Immunogenicity Analysis for Host Cell Protein (HCP) impurities

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Description

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.

Contributors

Brian Roberts, Ph.D.

Brian Roberts is the scientific director of the EpiVax Preclinical Immunology program. Dr. Roberts received his Ph.D. in Cell and Molecular Biology from the University of Vermont in 2012. His research in the laboratory of Dr Sally Huber focused on the role of toll-like receptors in sex differences in viral-induced autoimmune myocarditis. Dr. Roberts joined EpiVax in 2015 as a postdoctoral researcher working primarily with the Tregitope team. In 2018 he became manager of the Protein Therapeutics group at EpiVax, and oversees the PANDA(Peptide Abbreviated New Drug Application) program, which provides synthetic generic peptide developers with in silico and in vitro immunogenicity assessments in advance of regulatory filing.

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Description

Contributors

Brian Roberts, Ph.D.