�ݺ�ߣshows by User: MerckMillipore

�ݺ�ߣshows by User: MerckMillipore / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: MerckMillipore / Fri, 28 Jul 2023 08:48:02 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: MerckMillipore Launch of our new Titanium Dioxide Alternative /slideshow/launch-of-our-new-titanium-dioxide-alternative-259479547/259479547 launchofpartecktacalciumcarbonatemerck20230623-230728084802-38d3b2c8
Parteck® TA (Calcium carbonate) Emprove® Essential The ideal morphology and particle size for enhanced opacity in tablet coating. ]]>
Parteck® TA (Calcium carbonate) Emprove® Essential The ideal morphology and particle size for enhanced opacity in tablet coating. ]]> Fri, 28 Jul 2023 08:48:02 GMT /slideshow/launch-of-our-new-titanium-dioxide-alternative-259479547/259479547 MerckMillipore@slideshare.net(MerckMillipore) Launch of our new Titanium Dioxide Alternative MerckMillipore Parteck® TA (Calcium carbonate) Emprove® Essential The ideal morphology and particle size for enhanced opacity in tablet coating. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/launchofpartecktacalciumcarbonatemerck20230623-230728084802-38d3b2c8-thumbnail.jpg?width=120&height=120&fit=bounds" /> Parteck® TA (Calcium carbonate) Emprove® Essential The ideal morphology and particle size for enhanced opacity in tablet coating.

Launch of our new Titanium Dioxide Alternative from Merck Life Sciences

]]> 165 0 https://cdn.slidesharecdn.com/ss_thumbnails/launchofpartecktacalciumcarbonatemerck20230623-230728084802-38d3b2c8-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 The Viscosity Reduction Platform: Viscosity-reducing excipients for improvement of filtration processes /slideshow/the-viscosity-reduction-platform-viscosityreducing-excipients-for-improvement-of-filtration-processes-258554138/258554138 viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230622065042-833578fb
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process. This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work. Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform]]>
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process. This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work. Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform]]> Thu, 22 Jun 2023 06:50:42 GMT /slideshow/the-viscosity-reduction-platform-viscosityreducing-excipients-for-improvement-of-filtration-processes-258554138/258554138 MerckMillipore@slideshare.net(MerckMillipore) The Viscosity Reduction Platform: Viscosity-reducing excipients for improvement of filtration processes MerckMillipore Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process. This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work. Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230622065042-833578fb-thumbnail.jpg?width=120&height=120&fit=bounds" /> Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process. This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work. Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform

The Viscosity Reduction Platform: Viscosity-reducing excipients for improvement of filtration processes from Merck Life Sciences

]]> 137 0 https://cdn.slidesharecdn.com/ss_thumbnails/viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230622065042-833578fb-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post

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0 Use of Excipients in Downstream Processing to Improve Protein Purification /slideshow/use-of-excipients-in-downstream-processing-to-improve-protein-purification-258286517/258286517 use-of-excipients-in-downstream-processing-to-improve-protein-purification-whitepaper-merck-230607075530-18a94f66
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms. This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.]]>
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms. This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.]]> Wed, 07 Jun 2023 07:55:29 GMT /slideshow/use-of-excipients-in-downstream-processing-to-improve-protein-purification-258286517/258286517 MerckMillipore@slideshare.net(MerckMillipore) Use of Excipients in Downstream Processing to Improve Protein Purification MerckMillipore Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms. This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/use-of-excipients-in-downstream-processing-to-improve-protein-purification-whitepaper-merck-230607075530-18a94f66-thumbnail.jpg?width=120&height=120&fit=bounds" /> Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms. This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.

Use of Excipients in Downstream Processing to Improve Protein Purification from Merck Life Sciences

]]> 55 0 https://cdn.slidesharecdn.com/ss_thumbnails/use-of-excipients-in-downstream-processing-to-improve-protein-purification-whitepaper-merck-230607075530-18a94f66-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post

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0 Exploring the protein stabilizing capability of surfactants against agitation stress and the underlying mechanisms /slideshow/exploring-the-protein-stabilizing-capability-of-surfactants-against-agitation-stress-and-the-underlying-mechanisms-258286495/258286495 exploring-the-protein-stabilizing-capability-of-surfactants-against-agitation-stress-merck-230607075416-5c8d9f2c
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase. One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations. Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms. ]]>
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase. One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations. Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms. ]]> Wed, 07 Jun 2023 07:54:16 GMT /slideshow/exploring-the-protein-stabilizing-capability-of-surfactants-against-agitation-stress-and-the-underlying-mechanisms-258286495/258286495 MerckMillipore@slideshare.net(MerckMillipore) Exploring the protein stabilizing capability of surfactants against agitation stress and the underlying mechanisms MerckMillipore Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase. One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations. Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/exploring-the-protein-stabilizing-capability-of-surfactants-against-agitation-stress-merck-230607075416-5c8d9f2c-thumbnail.jpg?width=120&height=120&fit=bounds" /> Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase. One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations. Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.

Exploring the protein stabilizing capability of surfactants against agitation stress and the underlying mechanisms from Merck Life Sciences

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0 The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein Formulation /slideshow/the-viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation/257731231 viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230508150518-e2b6a6fc
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection. This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity. To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform]]>
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection. This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity. To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform]]> Mon, 08 May 2023 15:05:17 GMT /slideshow/the-viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation/257731231 MerckMillipore@slideshare.net(MerckMillipore) The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein Formulation MerckMillipore Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection. This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity. To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230508150518-e2b6a6fc-thumbnail.jpg?width=120&height=120&fit=bounds" /> Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection. This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity. To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform

The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein Formulation from Merck Life Sciences

]]> 48 0 https://cdn.slidesharecdn.com/ss_thumbnails/viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230508150518-e2b6a6fc-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post

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0 Characterization of monoclonal antibodies and Antibody drug conjugates by Surface Plasmon Resonance /slideshow/characterization-of-monoclonal-antibodies-and-antibody-drug-conjugates-by-surface-plasmon-resonance-254773447/254773447 final-221206082302-adb548a6
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr Highlights of this webinar: - Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs. - SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations. - Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies. - The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process Detailed description: Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life. An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo. Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs. ]]>
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr Highlights of this webinar: - Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs. - SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations. - Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies. - The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process Detailed description: Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life. An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo. Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs. ]]> Tue, 06 Dec 2022 08:23:02 GMT /slideshow/characterization-of-monoclonal-antibodies-and-antibody-drug-conjugates-by-surface-plasmon-resonance-254773447/254773447 MerckMillipore@slideshare.net(MerckMillipore) Characterization of monoclonal antibodies and Antibody drug conjugates by Surface Plasmon Resonance MerckMillipore Watch the presentation of this webinar: https://bit.ly/3Pjpjvr Highlights of this webinar: - Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs. - SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations. - Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies. - The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process Detailed description: Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life. An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo. Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/final-221206082302-adb548a6-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar: https://bit.ly/3Pjpjvr Highlights of this webinar: - Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs. - SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations. - Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies. - The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process Detailed description: Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life. An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo. Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.

Characterization of monoclonal antibodies and Antibody drug conjugates by Surface Plasmon Resonance from Merck Life Sciences

]]> 91 0 https://cdn.slidesharecdn.com/ss_thumbnails/final-221206082302-adb548a6-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 The Role of BioPhorum Extractables Data in the Effective Adoption of Single-Use Systems /MerckMillipore/the-role-of-biophorum-extractables-data-in-the-effective-adoption-of-singleuse-systems-252513039 whitepaper-the-role-of-biophorum-extractables-mk-220811104508-07d8034a
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study. Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio ]]>
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study. Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio ]]> Thu, 11 Aug 2022 10:45:08 GMT /MerckMillipore/the-role-of-biophorum-extractables-data-in-the-effective-adoption-of-singleuse-systems-252513039 MerckMillipore@slideshare.net(MerckMillipore) The Role of BioPhorum Extractables Data in the Effective Adoption of Single-Use Systems MerckMillipore Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study. Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/whitepaper-the-role-of-biophorum-extractables-mk-220811104508-07d8034a-thumbnail.jpg?width=120&height=120&fit=bounds" /> Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study. Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio

The Role of BioPhorum Extractables Data in the Effective Adoption of Single-Use Systems from Merck Life Sciences

]]> 14 0 https://cdn.slidesharecdn.com/ss_thumbnails/whitepaper-the-role-of-biophorum-extractables-mk-220811104508-07d8034a-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post

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0 The Future of Pharma- and Biopharmaceutical Audits /slideshow/the-future-of-pharma-and-biopharmaceutical-audits-252413488/252413488 webinarthefutureofpharmaandbiopharmaceuticalaudits-220803112229-575e193a
Watch the recording of this presentation here: https://bit.ly/3zTOpe4 Detailed description: SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits. In this webinar, you will learn: • Regulatory overview of remote audits • The technologies needed to support the audit process • What types of inspections are possible with the use of these technologies • How audits may look in the future Presented by: Daniel Buescher, Product Manager - Digital Solutions]]>
Watch the recording of this presentation here: https://bit.ly/3zTOpe4 Detailed description: SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits. In this webinar, you will learn: • Regulatory overview of remote audits • The technologies needed to support the audit process • What types of inspections are possible with the use of these technologies • How audits may look in the future Presented by: Daniel Buescher, Product Manager - Digital Solutions]]> Wed, 03 Aug 2022 11:22:28 GMT /slideshow/the-future-of-pharma-and-biopharmaceutical-audits-252413488/252413488 MerckMillipore@slideshare.net(MerckMillipore) The Future of Pharma- and Biopharmaceutical Audits MerckMillipore Watch the recording of this presentation here: https://bit.ly/3zTOpe4 Detailed description: SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits. In this webinar, you will learn: • Regulatory overview of remote audits • The technologies needed to support the audit process • What types of inspections are possible with the use of these technologies • How audits may look in the future Presented by: Daniel Buescher, Product Manager - Digital Solutions <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/webinarthefutureofpharmaandbiopharmaceuticalaudits-220803112229-575e193a-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the recording of this presentation here: https://bit.ly/3zTOpe4 Detailed description: SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits. In this webinar, you will learn: • Regulatory overview of remote audits • The technologies needed to support the audit process • What types of inspections are possible with the use of these technologies • How audits may look in the future Presented by: Daniel Buescher, Product Manager - Digital Solutions

The Future of Pharma- and Biopharmaceutical Audits from Merck Life Sciences

]]> 259 0 https://cdn.slidesharecdn.com/ss_thumbnails/webinarthefutureofpharmaandbiopharmaceuticalaudits-220803112229-575e193a-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Landscape /slideshow/moving-your-gene-therapy-from-rd-to-ind-how-to-navigate-the-regulatory-landscape-252412280/252412280 20220728ebgenetherapyalisonmanjula-220803091732-09a6da83
Watch the recording of this presentation here: https://bit.ly/3SqOsoP Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years. Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance. In this webinar, we'll answer: • Which regulatory guidelines do you need to comply for your INDs? • When do you start implementing GMPs and validated assays? • How do you get your QC testing strategy ‘right the first time’? • How do you ensure testing is not your rate limiting step for the IND submission? Presented by: Manjula Aysola, Senior Regulatory Consultant Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions]]>
Watch the recording of this presentation here: https://bit.ly/3SqOsoP Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years. Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance. In this webinar, we'll answer: • Which regulatory guidelines do you need to comply for your INDs? • When do you start implementing GMPs and validated assays? • How do you get your QC testing strategy ‘right the first time’? • How do you ensure testing is not your rate limiting step for the IND submission? Presented by: Manjula Aysola, Senior Regulatory Consultant Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions]]> Wed, 03 Aug 2022 09:17:31 GMT /slideshow/moving-your-gene-therapy-from-rd-to-ind-how-to-navigate-the-regulatory-landscape-252412280/252412280 MerckMillipore@slideshare.net(MerckMillipore) Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Landscape MerckMillipore Watch the recording of this presentation here: https://bit.ly/3SqOsoP Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years. Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance. In this webinar, we'll answer: • Which regulatory guidelines do you need to comply for your INDs? • When do you start implementing GMPs and validated assays? • How do you get your QC testing strategy ‘right the first time’? • How do you ensure testing is not your rate limiting step for the IND submission? Presented by: Manjula Aysola, Senior Regulatory Consultant Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/20220728ebgenetherapyalisonmanjula-220803091732-09a6da83-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the recording of this presentation here: https://bit.ly/3SqOsoP Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years. Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance. In this webinar, we'll answer: • Which regulatory guidelines do you need to comply for your INDs? • When do you start implementing GMPs and validated assays? • How do you get your QC testing strategy ‘right the first time’? • How do you ensure testing is not your rate limiting step for the IND submission? Presented by: Manjula Aysola, Senior Regulatory Consultant Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions

Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Landscape from Merck Life Sciences

]]> 96 0 https://cdn.slidesharecdn.com/ss_thumbnails/20220728ebgenetherapyalisonmanjula-220803091732-09a6da83-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 Identity testing by NGS as a means of risk mitigation for viral gene therapies /slideshow/identity-testing-by-ngs-as-a-means-of-risk-mitigation-for-viral-gene-therapies/252146802 ngsidassaywebinarslides-23june2022-220708105812-6dd1614d
Watch the presentation of this webinar here: https://bit.ly/3RijkHC Detailed description: Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented. The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches. In this webinar, we'll explore: • Regulatory requirements for identity testing • NGS applications for identity testing as compared to traditional methods • A case study on the impact of not establishing a proper risk-based testing strategy Presented by: Bradley Hasson, Director of Lab Operations for NGS Services]]>
Watch the presentation of this webinar here: https://bit.ly/3RijkHC Detailed description: Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented. The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches. In this webinar, we'll explore: • Regulatory requirements for identity testing • NGS applications for identity testing as compared to traditional methods • A case study on the impact of not establishing a proper risk-based testing strategy Presented by: Bradley Hasson, Director of Lab Operations for NGS Services]]> Fri, 08 Jul 2022 10:58:12 GMT /slideshow/identity-testing-by-ngs-as-a-means-of-risk-mitigation-for-viral-gene-therapies/252146802 MerckMillipore@slideshare.net(MerckMillipore) Identity testing by NGS as a means of risk mitigation for viral gene therapies MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3RijkHC Detailed description: Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented. The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches. In this webinar, we'll explore: • Regulatory requirements for identity testing • NGS applications for identity testing as compared to traditional methods • A case study on the impact of not establishing a proper risk-based testing strategy Presented by: Bradley Hasson, Director of Lab Operations for NGS Services <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ngsidassaywebinarslides-23june2022-220708105812-6dd1614d-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3RijkHC Detailed description: Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented. The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches. In this webinar, we'll explore: • Regulatory requirements for identity testing • NGS applications for identity testing as compared to traditional methods • A case study on the impact of not establishing a proper risk-based testing strategy Presented by: Bradley Hasson, Director of Lab Operations for NGS Services

Identity testing by NGS as a means of risk mitigation for viral gene therapies from Merck Life Sciences

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0 Latest advancements of melt based 3D printing technologies for oral drug delivery /slideshow/latest-advancements-of-melt-based-3d-printing-technologies-for-oral-drug-delivery/252054340 2022-06-233dpwebinarfinal-220624125719-41fb75fa
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4 The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing. Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented: The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures. In this webinar, you will learn: • Latest advancements of melt based 3D printing approaches • Application examples for the individual technologies • Deep dive in the MED® 3D printing technology to design dedicated drug release profiles Presented by: Dr. Thomas Kipping, Head of Drug Carriers Dr. Xianghao Zuo, Deputy Director of R&D, Triastek]]>
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4 The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing. Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented: The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures. In this webinar, you will learn: • Latest advancements of melt based 3D printing approaches • Application examples for the individual technologies • Deep dive in the MED® 3D printing technology to design dedicated drug release profiles Presented by: Dr. Thomas Kipping, Head of Drug Carriers Dr. Xianghao Zuo, Deputy Director of R&D, Triastek]]> Fri, 24 Jun 2022 12:57:18 GMT /slideshow/latest-advancements-of-melt-based-3d-printing-technologies-for-oral-drug-delivery/252054340 MerckMillipore@slideshare.net(MerckMillipore) Latest advancements of melt based 3D printing technologies for oral drug delivery MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3A2WcH4 The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing. Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented: The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures. In this webinar, you will learn: • Latest advancements of melt based 3D printing approaches • Application examples for the individual technologies • Deep dive in the MED® 3D printing technology to design dedicated drug release profiles Presented by: Dr. Thomas Kipping, Head of Drug Carriers Dr. Xianghao Zuo, Deputy Director of R&D, Triastek <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2022-06-233dpwebinarfinal-220624125719-41fb75fa-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3A2WcH4 The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing. Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented: The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures. In this webinar, you will learn: • Latest advancements of melt based 3D printing approaches • Application examples for the individual technologies • Deep dive in the MED® 3D printing technology to design dedicated drug release profiles Presented by: Dr. Thomas Kipping, Head of Drug Carriers Dr. Xianghao Zuo, Deputy Director of R&D, Triastek

Latest advancements of melt based 3D printing technologies for oral drug delivery from Merck Life Sciences

]]> 124 0 https://cdn.slidesharecdn.com/ss_thumbnails/2022-06-233dpwebinarfinal-220624125719-41fb75fa-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes and Other Key Steps /slideshow/cart-manufacturing-innovations-that-work-automating-low-volume-processes-and-other-key-steps-251953253/251953253 car-tmanufacturinginnovationsthatwork-automatinglowvolumeprocessesandotherkeystepsv3-220609131820-4bd619a0
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed. This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection. In this webinar, you will: • Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps • Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal • Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps Presented by: Benjamin Ross-Johnsrud, Acoustic Technology Expert Robert Scott, Mechanical Engineer III]]>
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed. This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection. In this webinar, you will: • Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps • Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal • Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps Presented by: Benjamin Ross-Johnsrud, Acoustic Technology Expert Robert Scott, Mechanical Engineer III]]> Thu, 09 Jun 2022 13:18:20 GMT /slideshow/cart-manufacturing-innovations-that-work-automating-low-volume-processes-and-other-key-steps-251953253/251953253 MerckMillipore@slideshare.net(MerckMillipore) CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes and Other Key Steps MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3NDNIKe Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed. This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection. In this webinar, you will: • Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps • Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal • Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps Presented by: Benjamin Ross-Johnsrud, Acoustic Technology Expert Robert Scott, Mechanical Engineer III <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/car-tmanufacturinginnovationsthatwork-automatinglowvolumeprocessesandotherkeystepsv3-220609131820-4bd619a0-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3NDNIKe Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed. This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection. In this webinar, you will: • Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps • Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal • Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps Presented by: Benjamin Ross-Johnsrud, Acoustic Technology Expert Robert Scott, Mechanical Engineer III

CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes and Other Key Steps from Merck Life Sciences

]]> 189 0 https://cdn.slidesharecdn.com/ss_thumbnails/car-tmanufacturinginnovationsthatwork-automatinglowvolumeprocessesandotherkeystepsv3-220609131820-4bd619a0-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 Viral safety of biologics: What's changing with the ICH Q5A revision? /slideshow/viral-safety-of-biologics-whats-changing-with-the-ich-q5a-revision/251894586 impactichq5arevbiologicswebinarmay2022final-220531203702-08bebb11
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg How does the ICH Q5A revision impact viral safety strategies for biologics? Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples. In this webinar, you will learn about: • The Importance of virus testing in biologics products • Regulatory landscape, expectations for the Q5A revision • What's new and changing • Examples of alternate testing schedules, impact on viral clearance Presented by: Manjula Aysola, Senior Regulatory Consultant Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions]]>
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg How does the ICH Q5A revision impact viral safety strategies for biologics? Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples. In this webinar, you will learn about: • The Importance of virus testing in biologics products • Regulatory landscape, expectations for the Q5A revision • What's new and changing • Examples of alternate testing schedules, impact on viral clearance Presented by: Manjula Aysola, Senior Regulatory Consultant Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions]]> Tue, 31 May 2022 20:37:01 GMT /slideshow/viral-safety-of-biologics-whats-changing-with-the-ich-q5a-revision/251894586 MerckMillipore@slideshare.net(MerckMillipore) Viral safety of biologics: What's changing with the ICH Q5A revision? MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3t7X9tg How does the ICH Q5A revision impact viral safety strategies for biologics? Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples. In this webinar, you will learn about: • The Importance of virus testing in biologics products • Regulatory landscape, expectations for the Q5A revision • What's new and changing • Examples of alternate testing schedules, impact on viral clearance Presented by: Manjula Aysola, Senior Regulatory Consultant Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/impactichq5arevbiologicswebinarmay2022final-220531203702-08bebb11-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3t7X9tg How does the ICH Q5A revision impact viral safety strategies for biologics? Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples. In this webinar, you will learn about: • The Importance of virus testing in biologics products • Regulatory landscape, expectations for the Q5A revision • What's new and changing • Examples of alternate testing schedules, impact on viral clearance Presented by: Manjula Aysola, Senior Regulatory Consultant Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions

Viral safety of biologics: What's changing with the ICH Q5A revision? from Merck Life Sciences

]]> 1323 0 https://cdn.slidesharecdn.com/ss_thumbnails/impactichq5arevbiologicswebinarmay2022final-220531203702-08bebb11-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration /slideshow/improve-operational-efficiency-by-over-30-with-product-process-systems-agnostic-orchestration-251846756/251846756 webinarfinalpresentation4thmay2022final-220524142853-0d3ff27c
Watch the presentation of this webinar here: https://bit.ly/3adaxWh When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs. They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost? In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement). To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle. Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance. In this webinar, let's explore: • Challenges of automation and digital technology adoption • What a product, process, and system agnostic platform entails • Applications and benefits of a process orchestration platform • Ensuring future readiness with process orchestration Presented by: Braj Nandan Thakur, Global Product Manager - Automation]]>
Watch the presentation of this webinar here: https://bit.ly/3adaxWh When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs. They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost? In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement). To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle. Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance. In this webinar, let's explore: • Challenges of automation and digital technology adoption • What a product, process, and system agnostic platform entails • Applications and benefits of a process orchestration platform • Ensuring future readiness with process orchestration Presented by: Braj Nandan Thakur, Global Product Manager - Automation]]> Tue, 24 May 2022 14:28:53 GMT /slideshow/improve-operational-efficiency-by-over-30-with-product-process-systems-agnostic-orchestration-251846756/251846756 MerckMillipore@slideshare.net(MerckMillipore) Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3adaxWh When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs. They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost? In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement). To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle. Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance. In this webinar, let's explore: • Challenges of automation and digital technology adoption • What a product, process, and system agnostic platform entails • Applications and benefits of a process orchestration platform • Ensuring future readiness with process orchestration Presented by: Braj Nandan Thakur, Global Product Manager - Automation <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/webinarfinalpresentation4thmay2022final-220524142853-0d3ff27c-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3adaxWh When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs. They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost? In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement). To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle. Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance. In this webinar, let's explore: • Challenges of automation and digital technology adoption • What a product, process, and system agnostic platform entails • Applications and benefits of a process orchestration platform • Ensuring future readiness with process orchestration Presented by: Braj Nandan Thakur, Global Product Manager - Automation

Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration from Merck Life Sciences

]]> 152 0 https://cdn.slidesharecdn.com/ss_thumbnails/webinarfinalpresentation4thmay2022final-220524142853-0d3ff27c-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 Insights from a Global Collaboration Accelerating Vaccine Development with an Optimized VLP Platform /slideshow/insights-from-a-global-collaboration-accelerating-vaccine-development-with-an-optimized-vlp-platform/251770025 vaccinecollaborationtechnovax12may2022finalv3-220512132216-ce9bf10a
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process. The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine. In this webinar, you will learn: • About building a priceless collaborative network with integrated solutions • Virus-Like Particle Vaccines • Process Development Overview and Challenges • Pre-clinical Results and Next Steps Presented by: Jose M. Galarza, PhD, President and Founder of TechnoVax Naomi Baer, Business development consultant, Emerging Biotech, BioProcess division Youssef Gaabouri, Eng. , Associate Director, Head of Sales Middle East & Africa, BioProcess division]]>
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process. The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine. In this webinar, you will learn: • About building a priceless collaborative network with integrated solutions • Virus-Like Particle Vaccines • Process Development Overview and Challenges • Pre-clinical Results and Next Steps Presented by: Jose M. Galarza, PhD, President and Founder of TechnoVax Naomi Baer, Business development consultant, Emerging Biotech, BioProcess division Youssef Gaabouri, Eng. , Associate Director, Head of Sales Middle East & Africa, BioProcess division]]> Thu, 12 May 2022 13:22:16 GMT /slideshow/insights-from-a-global-collaboration-accelerating-vaccine-development-with-an-optimized-vlp-platform/251770025 MerckMillipore@slideshare.net(MerckMillipore) Insights from a Global Collaboration Accelerating Vaccine Development with an Optimized VLP Platform MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process. The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine. In this webinar, you will learn: • About building a priceless collaborative network with integrated solutions • Virus-Like Particle Vaccines • Process Development Overview and Challenges • Pre-clinical Results and Next Steps Presented by: Jose M. Galarza, PhD, President and Founder of TechnoVax Naomi Baer, Business development consultant, Emerging Biotech, BioProcess division Youssef Gaabouri, Eng. , Associate Director, Head of Sales Middle East & Africa, BioProcess division <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/vaccinecollaborationtechnovax12may2022finalv3-220512132216-ce9bf10a-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process. The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine. In this webinar, you will learn: • About building a priceless collaborative network with integrated solutions • Virus-Like Particle Vaccines • Process Development Overview and Challenges • Pre-clinical Results and Next Steps Presented by: Jose M. Galarza, PhD, President and Founder of TechnoVax Naomi Baer, Business development consultant, Emerging Biotech, BioProcess division Youssef Gaabouri, Eng. , Associate Director, Head of Sales Middle East & Africa, BioProcess division

Insights from a Global Collaboration Accelerating Vaccine Development with an Optimized VLP Platform from Merck Life Sciences

]]> 82 0 https://cdn.slidesharecdn.com/ss_thumbnails/vaccinecollaborationtechnovax12may2022finalv3-220512132216-ce9bf10a-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

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0 Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems /slideshow/riskbased-qualification-of-xray-sterilization-for-singleuse-systems/251731833 webinarpresentationrisk-basedqualificationofx-raysterilizationmay05final-220506152255-ab5d3294
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods. The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods. In this webinar, you will learn about: • The comparison of gamma and X-ray irradiation sterilization • A risk-based qualification test strategy • Data evaluation of gamma versus X-ray sterilized single-use components Presented by: Monica Cardona, Global Senior Program Manager Paul Killian, Ph.D., R&D Director, Analytical Technologies]]>
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods. The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods. In this webinar, you will learn about: • The comparison of gamma and X-ray irradiation sterilization • A risk-based qualification test strategy • Data evaluation of gamma versus X-ray sterilized single-use components Presented by: Monica Cardona, Global Senior Program Manager Paul Killian, Ph.D., R&D Director, Analytical Technologies]]> Fri, 06 May 2022 15:22:54 GMT /slideshow/riskbased-qualification-of-xray-sterilization-for-singleuse-systems/251731833 MerckMillipore@slideshare.net(MerckMillipore) Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3vQf0qv In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods. The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods. In this webinar, you will learn about: • The comparison of gamma and X-ray irradiation sterilization • A risk-based qualification test strategy • Data evaluation of gamma versus X-ray sterilized single-use components Presented by: Monica Cardona, Global Senior Program Manager Paul Killian, Ph.D., R&D Director, Analytical Technologies <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/webinarpresentationrisk-basedqualificationofx-raysterilizationmay05final-220506152255-ab5d3294-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3vQf0qv In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods. The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods. In this webinar, you will learn about: • The comparison of gamma and X-ray irradiation sterilization • A risk-based qualification test strategy • Data evaluation of gamma versus X-ray sterilized single-use components Presented by: Monica Cardona, Global Senior Program Manager Paul Killian, Ph.D., R&D Director, Analytical Technologies

Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems from Merck Life Sciences

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0 Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot release /slideshow/rapid-replication-competent-adenovirus-rrca-detection-accelerate-your-lot-release-251706477/251706477 rrcawebinarslides-final-en-22-220502130818
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release. Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines. In this webinar, you will learn about: • Regulatory framework for adenoviral vector products • Considerations for lot release testing of adenoviral-based therapies • Advantages of a rapid method for RCA testing on production lot material Presented by: Axel Fun, Ph.D., Principal Scientist Alberto Santana, MBA, Product Manager, Biologics Biosafety Testing]]>
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release. Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines. In this webinar, you will learn about: • Regulatory framework for adenoviral vector products • Considerations for lot release testing of adenoviral-based therapies • Advantages of a rapid method for RCA testing on production lot material Presented by: Axel Fun, Ph.D., Principal Scientist Alberto Santana, MBA, Product Manager, Biologics Biosafety Testing]]> Mon, 02 May 2022 13:08:18 GMT /slideshow/rapid-replication-competent-adenovirus-rrca-detection-accelerate-your-lot-release-251706477/251706477 MerckMillipore@slideshare.net(MerckMillipore) Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot release MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release. Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines. In this webinar, you will learn about: • Regulatory framework for adenoviral vector products • Considerations for lot release testing of adenoviral-based therapies • Advantages of a rapid method for RCA testing on production lot material Presented by: Axel Fun, Ph.D., Principal Scientist Alberto Santana, MBA, Product Manager, Biologics Biosafety Testing <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/rrcawebinarslides-final-en-22-220502130818-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release. Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines. In this webinar, you will learn about: • Regulatory framework for adenoviral vector products • Considerations for lot release testing of adenoviral-based therapies • Advantages of a rapid method for RCA testing on production lot material Presented by: Axel Fun, Ph.D., Principal Scientist Alberto Santana, MBA, Product Manager, Biologics Biosafety Testing

Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot release from Merck Life Sciences

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0 The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patient's Taste Test /slideshow/the-high-intensity-sweeteners-neotame-and-sucralose-2-ways-to-ace-the-patients-taste-test/251706097 webinar2waystoacethepatientstastetestneotameandsucralose20220426-220502115102
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations. Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects: • excellent sugar-like taste profile • outstanding sweetness factors • use effectiveness • enhanced stability We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception. In this webinar, you will learn: • How to optimize the patients' taste experience of your pharmaceuticals • How sweeteners can be differentiated by their sensory profiles and features • How our new product offering Neotame can be effectively used in your targeted formulations Presented by: Almut von der Brelie, Senior Manager Strategic Marketing Excipients for Solid Applications]]>
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations. Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects: • excellent sugar-like taste profile • outstanding sweetness factors • use effectiveness • enhanced stability We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception. In this webinar, you will learn: • How to optimize the patients' taste experience of your pharmaceuticals • How sweeteners can be differentiated by their sensory profiles and features • How our new product offering Neotame can be effectively used in your targeted formulations Presented by: Almut von der Brelie, Senior Manager Strategic Marketing Excipients for Solid Applications]]> Mon, 02 May 2022 11:51:02 GMT /slideshow/the-high-intensity-sweeteners-neotame-and-sucralose-2-ways-to-ace-the-patients-taste-test/251706097 MerckMillipore@slideshare.net(MerckMillipore) The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patient's Taste Test MerckMillipore Watch the presentation of this webinar here: https://bit.ly/3vQyN7K Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations. Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects: • excellent sugar-like taste profile • outstanding sweetness factors • use effectiveness • enhanced stability We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception. In this webinar, you will learn: • How to optimize the patients' taste experience of your pharmaceuticals • How sweeteners can be differentiated by their sensory profiles and features • How our new product offering Neotame can be effectively used in your targeted formulations Presented by: Almut von der Brelie, Senior Manager Strategic Marketing Excipients for Solid Applications <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/webinar2waystoacethepatientstastetestneotameandsucralose20220426-220502115102-thumbnail.jpg?width=120&height=120&fit=bounds" /> Watch the presentation of this webinar here: https://bit.ly/3vQyN7K Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations. Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects: • excellent sugar-like taste profile • outstanding sweetness factors • use effectiveness • enhanced stability We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception. In this webinar, you will learn: • How to optimize the patients' taste experience of your pharmaceuticals • How sweeteners can be differentiated by their sensory profiles and features • How our new product offering Neotame can be effectively used in your targeted formulations Presented by: Almut von der Brelie, Senior Manager Strategic Marketing Excipients for Solid Applications

The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patient's Taste Test from Merck Life Sciences

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0 The Developability Classification System (DCS): Enabling an Optimized Approach for Formulation of Poorly Soluble Molecules /slideshow/the-developability-classification-system-dcs-enabling-an-optimized-approach-for-formulation-of-poorly-soluble-molecules-251691675/251691675 merc-22047prowhitepapersafcsolubilitymrklow-220429105626
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS). The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed. #solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment]]>
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS). The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed. #solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment]]> Fri, 29 Apr 2022 10:56:26 GMT /slideshow/the-developability-classification-system-dcs-enabling-an-optimized-approach-for-formulation-of-poorly-soluble-molecules-251691675/251691675 MerckMillipore@slideshare.net(MerckMillipore) The Developability Classification System (DCS): Enabling an Optimized Approach for Formulation of Poorly Soluble Molecules MerckMillipore This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS). The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed. #solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/merc-22047prowhitepapersafcsolubilitymrklow-220429105626-thumbnail.jpg?width=120&height=120&fit=bounds" /> This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS). The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed. #solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment

The Developability Classification System (DCS): Enabling an Optimized Approach for Formulation of Poorly Soluble Molecules from Merck Life Sciences

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0 How to Accelerate and Enhance ADC Therapies /slideshow/how-to-accelerate-and-enhance-adc-therapies/251677020 adcore-chetosenasar-adcexpresswebinarapril212022finalupdate-220427125119
In this webinar, you will learn about: The advantages of using advanced intermediates to develop ADC therapies How to increase ADC solubility and efficiency Fast, small-scale ADC library generation Seamless supply chain with reduced complexity and regulatory support The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window. Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.]]>
In this webinar, you will learn about: The advantages of using advanced intermediates to develop ADC therapies How to increase ADC solubility and efficiency Fast, small-scale ADC library generation Seamless supply chain with reduced complexity and regulatory support The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window. Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.]]> Wed, 27 Apr 2022 12:51:19 GMT /slideshow/how-to-accelerate-and-enhance-adc-therapies/251677020 MerckMillipore@slideshare.net(MerckMillipore) How to Accelerate and Enhance ADC Therapies MerckMillipore In this webinar, you will learn about: The advantages of using advanced intermediates to develop ADC therapies How to increase ADC solubility and efficiency Fast, small-scale ADC library generation Seamless supply chain with reduced complexity and regulatory support The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window. Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/adcore-chetosenasar-adcexpresswebinarapril212022finalupdate-220427125119-thumbnail.jpg?width=120&height=120&fit=bounds" /> In this webinar, you will learn about: The advantages of using advanced intermediates to develop ADC therapies How to increase ADC solubility and efficiency Fast, small-scale ADC library generation Seamless supply chain with reduced complexity and regulatory support The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window. Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.

How to Accelerate and Enhance ADC Therapies from Merck Life Sciences

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0 https://cdn.slidesharecdn.com/profile-photo-MerckMillipore-48x48.jpg?cb=1690534063 Not intended for US & CA visitors. Merck Life Sciences is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of Life Science. Merck Millipore is known as EMD Millipore in the U.S. and Canada. www.merckmillipore.com https://cdn.slidesharecdn.com/ss_thumbnails/launchofpartecktacalciumcarbonatemerck20230623-230728084802-38d3b2c8-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/launch-of-our-new-titanium-dioxide-alternative-259479547/259479547 Launch of our new Tita... https://cdn.slidesharecdn.com/ss_thumbnails/viscosity-reduction-platform-viscosity-reducing-excipients-for-protein-formulation-whitepaper-merck-230622065042-833578fb-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/the-viscosity-reduction-platform-viscosityreducing-excipients-for-improvement-of-filtration-processes-258554138/258554138 The Viscosity Reductio... https://cdn.slidesharecdn.com/ss_thumbnails/use-of-excipients-in-downstream-processing-to-improve-protein-purification-whitepaper-merck-230607075530-18a94f66-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/use-of-excipients-in-downstream-processing-to-improve-protein-purification-258286517/258286517 Use of Excipients in D...