Support For Regulatory Submission And Feedback By Applying State Of The Art In Silico And In Vitro Tools

An understanding of the potential immunogenicity risk of your therapeutic candidate is a key part of pre-clinical development. While human primary cell assays can provide vital data to help support this assessment, the design and qualification of such human in vitro assays is key to generating high quality, reliable data to support regulatory filings. Here, we discuss how a panel of healthy donors can be pre-qualified for specific assays and how this donor panel can then be used in studies to assess the immunogenicity risk of therapeutics.