Author Archives: Eric Bishop

eBook: Process-Related Impurities — Emerging Strategies for Detection, Identification, and Management of Host-Cell Proteins

Host-cell proteins (HCPs) represent a major class of process-related impurities (PRIs) that are generated during biopharmaceutical manufacture. Although the vast majority of such proteins are removed from a drug substance during downstream purification, residual HCPs can remain in a finished drug product. Even in minimal concentrations, copurifying HCPs can pose safety risks and compromise protein-product yield, efficacy, and stability. Thus, regulatory agencies consider the presence of HCPs to be a critical quality attribute (CQA). Sufficient clearance of these impurities helps…

Ask the Expert: Improving Host-Cell Protein Detection By Enriching Mass Spectrometry Samples

Enzyme-linked immunosorbent assays (ELISAs) remain the industry standard for process monitoring and lot-release testing for host-cell proteins (HCPs), but researchers need orthogonal tests to confirm that an ELISA is fit for purpose. On 22 April 2020, Eric Bishop (vice president of research and development at Cygnus Technologies) delivered an “Ask the Expert” presentation about his company’s solution: mass spectrometry (MS) preceded by a novel Antibody Affinity Extraction (AAE) technique. Bishop explained that an AAE step can magnify a sample’s HCP…

Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

Host cell proteins (HCP) constitute a major group of impurities for biologic drugs produced using cell culture technology. Even at nanogram per milligram concentrations of HCP to drug substance (DS), HCPs can elicit undesired immune response, interfere with drug safety and efficacy, or impact DS stability. A broadly-reactive HCP ELISA should be used during the purification processes to ensure removal of HCPs and to demonstrate process consistency and final DS purity. Regulatory authorities are requesting biopharmaceutical companies employ orthogonal methods…