Bioanalytics – Biomolecular
2019 PharmSci 360
The 2019 Final FDA Guidance For Industry: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, defines the robust requirements for validating a clinical immunogenicity assay. The goals of detection of immunogenicity for Clinical vs. Non-clinical studies are different, therefore the approach to method validation can be adjusted for nonclinical safety assessment to be both time and cost effective while meeting the goal of measurement of an immune response that impacts PK, PD, or the toxicology findings. This Rapid Fire will review a Method Validation strategy for nonclinical immunogenicity that will answer the questions required in a safety toxicology study while employing a streamlined workflow resulting in shortened timelines and cost savings.