New US Pharmacopeia General Chapter: 1132.1
May 1 2023
Residual HCP measurement in biopharmaceuticals by mass spectrometry
Host Cell Protein (HCP) analysis by mass spectrometry (MS) is our passion and mission, so we are excited to share the news! The USP 1132 chapter has been updated with the new 1132.1 chapter on identifying and quantifying HCPs using MS - and is now available in the Pharmacopeial Forum for public comments.
The United States Pharmacopeia (USP) is the most comprehensive source for standards about drug quality, purity, strength, and identity worldwide. USP standards are widely used as a reference by the FDA. USP general chapters outline the accepted processes, tests, and procedures for developing, manufacturing, and regulating pharmaceutical products.
The USP 1132 chapter on Residual Host Cell Protein Measurement in Biopharmaceuticals focuses almost exclusively on immunoassay methods, with only a limited discussion on supporting/orthogonal technologies.
The new USP 1132.1 chapter, Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry, contains general guidance and best practices for MS-based identification and quantification of high-risk and high-abundance HCPs.
This update of the USP 1132 chapter will pave the way for significant changes in the pharmaceutical industry
We're looking into a shift in the way HCP analysis is perceived and executed. Our COO, Ejvind Mørtz, looks forward to discussing the impact of the new chapter at the upcoming BEBPA 2023 HCP conference.
Learn more about how to investigate HCPs in biologics on our website or contact us to book a meeting where you can discuss the new possibilities and what it means for your biologic drug characterization..
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