Director, Head of Product Quality and Occupational Toxicology Genentech Inc South San Francisco, California, United States
Impurities in biologic therapeutics (“biologics”) can arise from various stages of bioprocessing, from the cell line utilized, to the cell culture media, to downstream purification and storage of the final formulation.Examples of impurities that can occur in biologics include host cell proteins (HCPs), leachables from product contact surfaces, and ligands used in protein purification.Such impurities have the potential to impact the quality, safety, and immunogenicity of biotherapeutic products. This presentation will provide an overview of current strategies employed in the safety assessment of impurities (e.g., HCPs) in biologics as well as the challenges faced and ongoing efforts to innovate and harmonize practices in this space. In this presentation, we will provide an overview of current approaches utilized in the safety assessment of impurity levels in biologics including regulatory guidance and publications utilized to support the hazard and risk assessment of impurities in biologics.We will also present case studies on the observed effects of such impurities (e.g., HCP) on drug substances and in the clinic. This presentation will enable attendees to develop an understanding of current approaches and the direction of the field of impurity assessment in the evolving landscape of biopharmaceutical development.
