Manufacturing and Bioprocessing
2019 PharmSci 360
Fengqiang Wang, PhD, MS
Merck and Co Inc
Kenilworth, New Jersey
The presence of residual host cell protein (HCP) impurities in biologics often cause immunogenicity concerns due to the use of non-human host cells and their foreign nature to humans. Other than a holistic control strategy to remove HCP to acceptable low levels in drug substance during bioprocess development, whether and when bioanalytical assays should be developed to monitor patients' immune response against HCPs during clinical development is often unclear. I will use historic case studies to stimulate discussions on the necessity of using bioanalytical assays to monitor anti-HCP antibodies in patient sera samples especially when the residual HCPs in drug product are at very low levels.