Senior Scientist Genentech, Inc. South San Francisco, California
Assays that measure the immunogenicity of therapeutics are a critical component of bioanalysis. Anti-drug antibodies (ADAs) and especially neutralizing ADAs (NAbs) which block the mechanism of action (MOA) of the drug can lead to impaired efficacy, increased clearance, and potential induction of safety events such as infusion-related reactions and anaphylaxis. As research evolves, next-generation therapeutics such as bispecific molecules and cellular therapies provide even greater risk of inducing ADAs. The increased potential for immunogenicity coupled with shortened timelines for drug development means that our bioanalytical strategies need to be flexible, agile and adaptive. A common issue In ADA and NAb assay development is matrix interference, whether from the drug itself or other factors contained within the specimen. Sample pretreatment is a method employed to get rid of the interfering factors. However, developing individualized sample pretreatment methods can be time-consuming, costly, and laborious. We propose the idea of a universal sample pretreatment method that with little optimization would be able to be employed across multiple assay formats, including both ELISA and cell-based assays.
Upon completion, participants will understand the importants of sample pretreatment in immunogenicity assays.
Upon completion, participants will be able describe common methods of sample pretreatment.
Upon completion, participants will have a clear idea of the challenges involved in developing a universal sample pretreatment method, as well as the considerable benefits for such a bioanalytical strategy.