large molecule studies
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Veeda has experience analyzing large molecule biosimilars including completing multiple studies on the PD, immunogenicity, and pharmacodynamics of enoxaparin using techniques like ELISA and chromogenic assays. They have analyzed over 3,783 samples for PK, PD, and immunogenicity. Veeda is also developing LC/MS/MS methods for analyzing molecules like human insulin and its analogs with proposed linearity ranges of 50pg/mL to 10,000pg/mL. Recently, Veeda validated and analyzed samples of molecules like G-CSF, insulin aspart, and C-peptide using commercially available ELISA kits, with a high percentage of samples within acceptance criteria.
large molecule studies
- 2. Biosimilar Analytical Experiences/ Capabilities: 展 Completed Enoxaparin PD end point and Immunogenicity studies (03 studies for US FDA, 01 study each for EU and ANVISA). 展 Pharmacodynamic endpoint-Anti-Xa detection and Anti-IIa detection using Chromogenic method. 展 Immunogenicity-Anti heparin PF4 screening assay & Total Ig GAM screening assay using ELISA technique. 展 TFPI detection using ELISA technique, Linearity range: 0.050 IU/mL to 0.200 IU/mL. 展 Heparin Clotting assay Coagulation method, Linearity range: 0.100 IU/mL to 1.00 IU/mL. 展 IgG, IgA & IgM Screening assay using ELISA technique. 展 Total no of sample Analyzed PK-14784, PD-3866 & Immunogenicity 3783 samples. Large Molecules by LC/MS/MS: Human insulin (Method Under Optimization stage): Method under development, approach is to have intact molecule analyzed in MS (SH-8060) (As multiple charged molecule MRM). Proposed Linearity Range- 50 pg/mL 10000 pg/mL. The other analogs of insulin (Glargine, aspart are also planned to develop). Why partner with Veeda? 展 Experienced technical staff for handling different Bioanalytical issues. 展 Variety of Mass platform (from sub ng to sub pg level) to handle different molecules. 展 Privately owned company with no con鍖ict of interest. 展 Assured Business Continuity. +91 79 3001 3000 info@veedacr.com www.veedacr.com Recent Experience of Large Molecules by Ligand binding assay: Veeda has recently developed and validated below large molecules as per current EMEA guidance using commercially available kits by ELISA technique of G-CSF, Insulin Aspart, C Peptide, using validated methods study samples were analyzed as below: Sr. No. Analyte No. of Samples Analyzed No. of Samples Analyzed for ISR % of ISR Samples within Acceptance 1 2 3 G-CSF 2142 158 98.7% Insulin Aspart 2139 158 94.9% C- Peptide 2400 176 98.2%