Bioanalytical Challenges For Cellular Immunogenicity Testing Using Validated ELISpot Assays

Advanced modalities do not easily lend themselves to the standard approaches for quantitating drug product as small and large molecule therapeutics do. Technologies such as qPCR, ddPCR and flow cytometry not typically used for this purpose, must be used to support these complex drug modalities. These platforms were not previously leveraged for extensive use in the regulated space for the purpose of drug quantitation. However, the industry is rapidly adjusting to define criteria for the development, validation and implementation of assays on these platforms to support this exciting field of growth for the biotech and pharma industry. We’ll discuss these topics along with an open Q&A session with our scientists developing and implementing these assays.