This live web event has ended. Thank you for attending.
Host cell protein (HCP) impurities are a critical quality attribute (CQA) because they may trigger undesired immune responses with the potential to compromise the safety and efficacy of biologics. The presence of immune responses to Chinese hamster ovary (CHO)-derived HCPs has contributed to the suspension of clinical trials in the past.
HCP impurities may be introduced during process development and manufacturing of biologics and biosimilar products. In recent years, in silico tools and approaches have been developed to quantify the immunogenic risk that these impurities may pose to patients. In silico screening allows for quick assessment and bench-top decision making for process development scientists tracking HCPs present in drug products.