New US Pharmacopeia guidelines could transform biologics impurity control
The new guidelines on using mass spectrometry to detect host cell protein impurities in biologics promise to enhance safety, efficacy and regulatory compliance.
In a defining move, the US Pharmacopeia (USP; MD, USA) — a nonprofit scientific organization that sets quality standards for medicines, food and dietary supplements in the US and globally — introduced a new general chapter on 1 December 2024, guiding the use of mass spectrometry (MS) for analyzing host cell protein (HCP) impurities in biologic drugs. This guidance has the potential to significantly enhance drug safety and efficacy, laying the foundation for a new era in biopharmaceutical development.
