Associate Director-Protein Therapeutics in Research and Development EpiVax, Inc. Providence, Rhode Island
Presentation Description: In 2017 the FDA released a draft guidance that requires generic peptide drug manufacturers to provide evidence that synthesis-related impurities found in their drug substance do not increase the immunogenicity of the drug product. Peptide drugs can be associated with impurities that result from changes in the sequences due to failures in the manufacturing process leading to deletions, insertions, integration of incorrect amino-acids, side-chain modifications and other modifications. We have used both immunoinformatics-driven analysis and in vitro validation assays to perform immunogenicity risk assessment of peptide generics. This combination of in silico and in vitro tools is referred to as the PANDA assay and can be used to support generic peptide drug equivalency in an ANDA application. This presentation will provide insight into the PANDA assay, illustrating the process with two case studies (such as Calcitonin and Teriparatide).
understand in silico and in vitro methods for assessment of generic peptide drugs and their impurities
understand the contribution of synthesis related impurities to immunogenicity
understand the recent FDA guidance on immunogenicity assessment of generic peptide drugs