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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

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


Date:
January 26, 2021
Time:
9:00 AM - 4:30 PM ET

Overview

FDA is hosting a 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 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

More information, including how to register, webcast links, and the meeting agenda, will be posted on this page once available.

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

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