New US Pharmacopeia General Chapter: 1132.1

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 very excited to share the news!

The new US Pharmacopeia general chapter on the identification and quantitation of HCP using MS is now available in the Pharmacopeial Forum for public comments.

The United States Pharmacopeia (USP) is the most comprehensive source for standards pertaining to drug quality, purity, strength, and identity worldwide. USP standards are recognized under US law and enforceable by the FDA. USP general chapters outline the accepted processes, tests, and procedures for developing, manufacturing, and regulating pharmaceutical products.

The USP General Chapter 1132 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 General Chapter 1132.1, titled 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 will pave the way for major changes in the pharmaceutical industry.

Our COO Ejvind Mørtz looks forward to discussing the impact of the new chapter at the upcoming BEBPA HCP conference.