Senior Research Scientist US FDA Silver Spring, Maryland, United States
In vitro assays and in silico methods can be used to characterize immunogenicity risk of product and process related impurities in generic peptides. This talk will discuss our experience with these assays, provide a regulatory framework to establish fit for purpose nature of these assays and will highlight common pitfalls with choice of assay platforms, suitability controls used, and data interpretation. Finally, remaining knowledge gaps and current Agency developments in this area will be discussed.
