Host cell protein detection gap risk mitigation: quantitative IAC-MS for ELISA antibody reagent coverage determination

• Main Authors: Daniel M. Waldera-Lupa (Author), Yvonne Jasper (Author), Pia Köhne (Author), Ronja Schwichtenhövel (Author), Heiner Falkenberg (Author), Thomas Flad (Author), Peter Happersberger (Author), Bernd Reisinger (Author), Alireza Dehghani (Author), Roland Moussa (Author), Thomas Waerner (Author)
• Format: Book
• Published: Taylor & Francis Group, 2021-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Host cell proteins (HCPs) must be sufficiently cleared from recombinant biopharmaceuticals during the downstream process (DSP) to ensure product quality, purity, and patient safety. For monitoring of HCP clearance, the typical method chosen is an enzyme-linked immunosorbent assay (ELISA) using polyc...