Director, Global R&D Bioassay and Microbiology Pfizer Lake Forest, Illinois, United States
Immunogenicity assessment is an important component for the approval of biological/biosimilar and complex generic drug products. For drug approvals that rely or partially rely on safety data from clinical experience with a reference product (RLD, or originator Reference Product) the reliability of non-clinical methods is paramount. Multiple in vitro methods may be required to obtain a full comparative characterization of the safety profile. We will describe some of the challenges associated with method development and implementation of relevant assay controls. Benefits to the use of in vitro methods, such as the ability to perform surveillance across a broad distribution of haplotypes, will also be discussed.
