Identification of a host cell protein impurity in therapeutic protein, P1.

Residual host cell proteins (HCPs) are process-related impurities present in biotherapeutics that can pose safety health risks to patients. An adequate control of HCP levels in the final product, and demonstration of HCP clearance throughout a product manufacturing process is critical for all biotherapeutic products. Developing effective downstream purification processes can be challenging as HCPs and product proteins may possess an affinity for each other or have similar physicochemical properties, resulting in co-purification.

Evaluation of automated Wes system as an analytical and characterization tool to support monoclonal antibody drug product development.

Monitoring and evaluation of critical quality attributes (cQA) in monoclonal antibodies (mAb) are a regulatory requirement in pharmaceutical industry. High molecular weight (HMW) species are of critical importance due to the potential risk associated with immunogenicity. HMW species are typically monitored by size exclusion chromatography (SEC).