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Evolution of Specifications and Analytical Methods During ...

Evolution of Specifications and Analytical Methods During Synthetic Peptide Drug DevelopmentMichael Verlander, , Proactive quality ComplianceBiologics Monographs 1 Peptides & Insulins Expert Committee MemberWebinar, March 14, 20192 2017 USP Definitions Challenges Regulatory guidance Specifications quality attributes/ Specifications for peptides Characterization Methods Qualification/validation requirements Peptide-related impurities Origins Regulatory guidance Examples of Purity/Related Substances method development Setting limits for peptide-related impurities Bioassay/bioidentityconsiderations Final thoughtsAgenda3 2017 USP Protein Any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size (May be)

manufacturing process and the associated analytical methods (in-process and final product) must be developed in parallel Because of their complexity, a relatively large number of tests is required to adequately describe the quality characteristics of peptides (the specification) Challenges

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