Updated HCP Risk Review
Understanding (HCP) Risks: An Updated Industry Perspective.
Phase-Appropriate Approaches to
HCP Risk Management
in 2025
Host Cell Proteins (HCPs) remain a major focus in biopharmaceutical manufacturing. In this article, we highlight a recently published industry review on HCP clinical safety and explore how evolving technologies are reshaping impurity profiling and risk assessment.
Occasionally, a new paper emerges that helps sharpen our collective lens on key topics across the biotech industry. One such paper was recently published in Biotechnology & Bioengineering, providing a comprehensive update on Host Cell Protein (HCP) Clinical Safety Risk Assessment.
While HCPs have been acknowledged in the field for decades, they can still introduce significant challenges if not properly addressed. This updated review offers a holistic and phase-appropriate approach to navigating HCPs and the issues that may arise from their presence during clinical development.
As analytical technologies continue to evolve, the integration of mass spectrometry (MS)-based techniques alongside standard ELISA and Western blot platforms is providing a broader, more precise framework for HCP characterization and quantification. These advancements are empowering teams to take a more robust, data-driven approach to HCP impurity profiling, helping mitigate safety risks and ensuring compliance with global regulatory expectations.
Read the full paper:
Host Cell Protein Clinical Safety Risk Assessment: An Updated Industry Review (PDF)
This blog post references the following industry publication:
Coye, M., Zhang, P., Smith, L., & Johnson, R. (2025). Host Cell Protein Clinical Safety Risk Assessment: An Updated Industry Review. Biotechnology and Bioengineering.
Used under educational and commentary purposes.