Host-Cell Protein Risk Management and Control During Bioprocess Development:A Consolidated Biotech Industry Review, Part 2

摘要

Even with increased understanding of host cell proteins (HCPs) and their potential risks, no practical approach has been made available for HCP risk management during bioprocess development. A BioPhorum Development Group (BPDG) team has identified common HCP-related risk factors and built a template for semiquantitative risk assessment during process development based on publicly available information. To this end, the BPDG HCP working teams assay and knowledge-sharing experts have established a common HCP risk assessment tool and mitigation strategy to guide bioprocess developers. In part 1 last month, we introduced this tool and described how to apply it when high levels of residual HCPs are found in a drug substance (DS). This month, we examine several other applications as well as address the limitations of our risk-assessment tool.