Drugs

Workshop on Generic Peptide Product Immunogenicity Risks

FDA has announced a 1/26 virtual workshop to communicate current regulatory thinking and considerations on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products. The agency says the workshop will discuss 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

According to an FDA notice, 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),” it says. Impurities may be present in peptide products, which may create the potential for differences in the ability to provoke an immune response in the body (immunogenicity) or affect product safety. “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,” it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome