GoodingBEBPA-HCP19.pdf

BEBPA HCP 2019 -- The most critical part of developing an ELISA for measuring Host Cell Protein (HCP) impurities in Biotherapeutics is generation of specific antibodies with appropriate recognition of the total population of HCPs potentially present in the product. The generation of the antiserum is dependent upon the sum of the individual biological responses (i.e., antibodies) of multiple animals to the antigen. Response is monitored throughout the program qualitatively by 1D (one dimension) Western Blot and adjustments are made to the antigen (immunogen) as needed to yield the broadest antigen recognition. Ultimately, the highest quality antisera from multiple animals are pooled. The quality of the final product is demonstrated through evaluation of coverage which is typically by 2D (two dimension) Western Blot or more recently by mass spectrometry. The BioCMC Group at Covance was tasked with development of a process capable of supporting this type of assessment. This capability will be illustrated through discussion of a typical antibody reagent production program.