Type of Posting: Notice of Intent to Revise
Posting Date: 01-Nov-2024
Targeted Official Date: TBD
Expert Committee: Biologics Monographs 2 –Proteins Expert Committee
USP general chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Liquid Chromatography-Mass Spectrometry was published in Pharmacopeial Forum 49(3) and subsequently approved for publication on November 1, 2024, in USP-NF 2025, Issue 1.
The posted file for this monograph did not reflect all content that the Expert Committee agreed to move to ballot during its deliberations. It is anticipated that changes will be processed via an appropriate accelerated revision vehicle.
The changes include the following:
- In the INTRODUCTION AND SCOPE section, the term ‘Residual HCP ELISA’ is being revised to ‘HCP ELISA’ to align with the Expert Committee’s decision on a public comment received.
- In the 4.1 Sample Preparation section, the term ‘product’ is being revised to ‘product protein’ in one instance to improve clarity.
- In the 5.1 Methods for HCP Quantitation section, the term ‘product’ is being revised to ‘product protein’ in three instances to improve clarity.
These intended changes have been articulated in the Commentary for USP-NF 2025, Issue 1.
Should you have any questions, please contact Ying Han, Principal Scientist (ying.han@usp.org).