USP Announces Corrections to General Chapter <1132.1> on Residual Host Cell Protein Measurement

SMART AAV Analytical Method Toolbox - Live Online Training

Recommendation

Tuesday, 17 June 2025 9 .00 - 15.30 h

SMART AAV Analytical Method Toolbox - Live Online Training
Suitable analytical methods to assess AAV quality during development and manufacturing

The United States Pharmacopeia (USP) has announced minor corrections to General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. The chapter was originally published in Pharmacopeial Forum 49(3) and subsequently approved for publication on 01 November 2024, in USP-NF 2025, Issue 1.

The following errata were published on 31 January 2025, and all changes will take effect on 01 May 2025:

Section 1. INTRODUCTION AND SCOPE – In paragraph 3: Change Residual HCP ELISA to: HCP ELISA.
Section 4. SAMPLE PREPARATION, CHROMATOGRAPHIC SEPARATION, AND MASS SPECTROMETRY ANALYSIS – In paragraph 4 in 4.1 Sample Preparation: Change product (or polysorbate) to: product protein (or polysorbate).
Section 5. QUANTITATION OF HCPS – In three instances in 5.1 Methods for HCP Quantitation: Change product to: product protein.
Section 7. BEST PRACTICES FOR REPORTING DATA FROM ELISA VERSUS LC-MS/MS – In paragraph 1 in 7.3 Comparison of ELISA and LC-MS/MS HCP Results: Change the comparing to: comparing.

For a comprehensive list of errata, refer to the USP-NF Errata Table.

Additionally, please see the Notice of Intent to Revise, published on 01 November 2024, for further details.