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  4. Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling - 01/26/2021 - 01/26/2021
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Virtual | Virtual

Event Title
Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling
January 26, 2021

January 26, 2021


FDA is hosting a virtual workshop to communicate current regulatory thinking and considerations on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products. In addition, this workshop seeks to generate discussions on the following four topics:

  • In silico methods to assess binding affinity to major histocompatibility complex (MHC): Method validation and MHC selection
  • In vitro assays to monitor innate immune activation and inflammation: technical challenges and best practices
  • Assays monitoring antigen-specific T cell activation: technical challenges and validations
  • Using non-clinical data to assess immunogenicity risk

Peptides are alpha amino acid polymers composed of 40 or fewer amino acids. Peptides can occur naturally in the body or can be produced in a laboratory through chemical synthesis (synthetic peptide products) or recombinant DNA (rDNA) technology using other living systems (e.g., bacteria). Impurities may be present in peptide products. In some circumstances, peptide-related impurities may create the potential for differences in the ability to provoke an immune response in the body (immunogenicity) or may otherwise affect the safety or effectiveness of a peptide drug product. Therefore, non-clinical (i.e., in vitro, in vivo, in silico) immunogenicity evaluations comparing a proposed synthetic generic peptide to the reference listed peptide product of rDNA origin are recommended.

Exciting Features:

  • Informative presentations from scientists representing FDA, academia, and industry
  • Scientific panel discussion on the technical challenges and method validation related to generic peptide products
  • Question and Answer sessions with leaders in industry, academia, and FDA

Your input at this workshop will assist FDA in our continued effort to explore and utilize the latest scientific thinking and practices to encourage and facilitate development of more generic peptide products.

Meeting Recordings

If you have any questions about this workshop, please email ORSEvents@fda.hhs.gov.

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