Rick Hancock, President of Althea, discusses industry trends in the outsourcing of biologics manufacturing. Featured in the October 2011 issue of BioPharmaceutical International publication.
This document discusses adapting program and student learning outcomes to lesson plans. It begins by outlining the agenda and distinguishing between program learning outcomes (PLOs), student learning outcomes at the syllabus level (SLOs), and student learning outcomes at the lesson level. It describes how to narrow syllabus-level SLOs down to more specific lesson-level SLOs. Finally, it addresses how to link assessments and activities to lesson-level SLOs and some challenges in assessing student learning at the lesson level.
Managing Objectionable Events in cGMP Cleanrooms: A Polyphasic Approach.Ajinomoto Althea
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Managing Objectionable Events in cGMP Cleanrooms: A Polyphasic Approach.
New technologies are finding far more organisms than before, creating the need for a rational, comprehensive approach to environmental monitoring.
BY J.S. SIDHU, C.T. TYLER, G. MA, AND M. SAMADPOUR, MOLECULAR EPIDEMIOLOGY, INC., AND E.J. BRANDRETH, ALTHEA TECHNOLOGIES
Corynex is a novel Protein Expression system that overcomes some of the most frustrating challenges with common microbial expression systems by secreting fully folded and active proteins directly into the cell medium with minimal host proteins and impurities. This greatly simplifies the entire purification process, lowers costs, and ultimately speeds time to market.
Genetic Engineering News article on transfection of DNA Vaccines. Several DNA Vaccines experts, including Althea's Magda Marquet, share their perspectives on DNA vaccine delivery and the future of theis great technology.
Fostering the Quality Based CMO-Sponsor RelationshipAjinomoto Althea
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Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.
Prefilled Syringes - A Container of Choice for PharmaAjinomoto Althea
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Special feature in the May 2012 issue of Drug Development and Delivery on Althea's Crystalomics technology, and how crystallized proteins create patient-friendly dosage and delivery.
Timing Is Everything In Protein Formulation by Angelo DePalma, Ph.D.Ajinomoto Althea
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The document discusses various perspectives on the optimal timing of protein formulation development. It notes that some experts recommend completing formulation before Phase I trials to address issues that cause drug failures, while others pursue formulation development throughout the drug development process as more data becomes available. The document also explores challenges like material limitations early in development and the rise of complex combination products. High-throughput screening and rational stepwise approaches to formulation are discussed.
Commercializing DNA vaccines presents several challenges at each phase of development. Early phases require formulations with short term stability and minimal manufacturing requirements. Later phases focus on establishing robust formulations through stability studies, optimizing and validating manufacturing processes, and selecting a final commercial container. Key formulation challenges include achieving room temperature stability while minimizing DNA degradation and particles. Buffers like TE buffer with ethanol addition can enhance plasmid stability, as demonstrated through accelerated stability studies. Final container selection requires consideration of DNA's affinity for glass and potential for metal ion leaching. Cold chain management is also a challenge, making lyophilization or liquid ambient temperature distribution desirable objectives.
DNA vaccines offer several advantages over traditional vaccine production methods:
1) They are faster to produce, taking 4-6 weeks from gene sequence to final vaccine compared to 6 months for traditional methods.
2) They are less expensive and use simpler production processes than traditional or recombinant protein vaccines.
3) Early safety studies have not found DNA integration into chromosomes as some initially feared.
However, DNA vaccine development has faced challenges and it has taken nearly 20 years to optimize the technology for human use. Significant progress has been made in manufacturing scale-up and ensuring product stability. If clinical trials continue to show DNA vaccines are safe and effective for humans, it could revolutionize vaccine production.
Corynex is a novel Protein Expression system that overcomes some of the most frustrating challenges with common microbial expression systems by secreting fully folded and active proteins directly into the cell medium with minimal host proteins and impurities. This greatly simplifies the entire purification process, lowers costs, and ultimately speeds time to market.
Genetic Engineering News article on transfection of DNA Vaccines. Several DNA Vaccines experts, including Althea's Magda Marquet, share their perspectives on DNA vaccine delivery and the future of theis great technology.
Fostering the Quality Based CMO-Sponsor RelationshipAjinomoto Althea
油
Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.
Prefilled Syringes - A Container of Choice for PharmaAjinomoto Althea
油
Special feature in the May 2012 issue of Drug Development and Delivery on Althea's Crystalomics technology, and how crystallized proteins create patient-friendly dosage and delivery.
Timing Is Everything In Protein Formulation by Angelo DePalma, Ph.D.Ajinomoto Althea
油
The document discusses various perspectives on the optimal timing of protein formulation development. It notes that some experts recommend completing formulation before Phase I trials to address issues that cause drug failures, while others pursue formulation development throughout the drug development process as more data becomes available. The document also explores challenges like material limitations early in development and the rise of complex combination products. High-throughput screening and rational stepwise approaches to formulation are discussed.
Commercializing DNA vaccines presents several challenges at each phase of development. Early phases require formulations with short term stability and minimal manufacturing requirements. Later phases focus on establishing robust formulations through stability studies, optimizing and validating manufacturing processes, and selecting a final commercial container. Key formulation challenges include achieving room temperature stability while minimizing DNA degradation and particles. Buffers like TE buffer with ethanol addition can enhance plasmid stability, as demonstrated through accelerated stability studies. Final container selection requires consideration of DNA's affinity for glass and potential for metal ion leaching. Cold chain management is also a challenge, making lyophilization or liquid ambient temperature distribution desirable objectives.
DNA vaccines offer several advantages over traditional vaccine production methods:
1) They are faster to produce, taking 4-6 weeks from gene sequence to final vaccine compared to 6 months for traditional methods.
2) They are less expensive and use simpler production processes than traditional or recombinant protein vaccines.
3) Early safety studies have not found DNA integration into chromosomes as some initially feared.
However, DNA vaccine development has faced challenges and it has taken nearly 20 years to optimize the technology for human use. Significant progress has been made in manufacturing scale-up and ensuring product stability. If clinical trials continue to show DNA vaccines are safe and effective for humans, it could revolutionize vaccine production.