Monitoring Host Cell Proteins In Drug Substances – Implications For Drug Product Efficacy, Quality And Safety

Ensuring the safety and stability of a biologic requires more than just meeting a total concentration threshold; it demands a deep understanding of the specific host cell proteins (HCPs) that persist through purification. While traditional monitoring methods offer a broad view of contamination, they often lack the granularity needed to identify "problematic" HCPs, such as proteases or lipases, that can compromise product quality or trigger adverse immune responses even at trace levels.

Modern analytical control strategies are shifting away from general detection toward targeted risk assessments. By identifying individual impurities and evaluating their clinical impact, manufacturers can make more informed decisions during process development and validation. This proactive approach is essential for navigating the complexities of modern drug substances and ensuring long-term therapeutic success. To discover the latest industry frameworks for standardizing HCP risk assessments and to learn how to enhance your analytical control strategy, access the full article for a comprehensive guide on advanced monitoring practices.