Event Overview
USP 1132.1 is a newly introduced chapter by the United States Pharmacopeia, effective from May 1, 2025. It outlines best practices for measuring residual host cell proteins (HCPs) in biologics using liquid chromatography–mass spectrometry (LC-MS/MS). The chapter extends USP 1132 by covering MS-based workflows for HCP identification, quantification, and validation.
The evolution from USP 1132 to 1132.1 reflects a broader industry transition from general quantification to precise characterisation. Traditional ELISA techniques provide an overview of total HCP levels but lack specificity.
In contrast, mass spectrometry enables detailed identification and quantification of individual HCPs. This distinction is critical when regulators ask not just “how much” but “which” HCPs remain in the drug substance.”
Key Learning Outcomes
- Understand the implications of USP 1132.1 in your drug candidate development
- What are the key steps to comply with USP 1132.1?
- Pros and Cons of each of the three HCP quantification methods outlined in USP 1132.1
What you need to know:
Dual-time broadcast, with starting times as follows:
Wednesday, 25 February 2026
- Broadcast #1 (Europe / Asia): 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
- Broadcast #2 (North America / Europe): 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)
Duration: Approximately 60 – 90 minutes, incl. Q&A.
- Registrants attending this online event’s live broadcast sessions will receive a ‘Certificate of Attendance’.
- If you’re unable to join the live broadcast, register anyway, and we’ll send you the recording.
- Join the BioQC user community for ongoing discussions after the event.
Who should attend?
- HCP Analysis, LC-MS, and Biologics Development roles, including: (Bio)Analytical Scientists, LC-MS/MS Scientists, Biochemists or Protein Chemists, and Principal Scientists in Analytical Development.
- Biologics Process Development and Characterisation roles, including: Upstream and Downstream Process Development Scientists, Purification Scientists, Bioprocess Engineers, Characterisation Scientists, CMC Scientists, and Formulation Scientists.
- Quality Roles (QA/QC) focused on Compliance, Release & Risk Management, including: QC Scientists (Biologics / Protein Analytics), QC Method Validation Specialists, QA Managers / Directors (Biologics / GMP), Compliance & Regulatory Specialists, and Data Integrity / Validation Specialists.
- Regulatory & CMC Roles focused on Filing Strategy, including: Regulatory Affairs Specialists / Managers (Biologics / CMC), CMC Regulatory Writers, and CMC Project Managers.
- Technical Leadership & Strategic Decision-Makers, including: Head / Director of Analytical Development, Head / Director of Biologics Development, Head / Director of CMC, VP/Director of Quality, and Technical Operations Leaders.
- Roles at CDMOs, including: MS-based HCP Service Providers, CDMO Project Managers, Biopharma Solutions Consultants, and Applications Scientists (LC, MS, HCP kits).
Related events as part of the webinar series
Register now:
- Moving HCP LC-MS analysis into a GMP environment – coming!
- Advanced ELISA-MS™ for Host Cell Protein (HCP) ELISA Antibody Characterisation – coming!
Presenters / Panellists
Victor Chrone, MSc
Scientist
Alphalyse (Denmark)
Moderators
Prof. Dr. Cari Sänger-van de Griend
Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.
Dr. Ewoud van Tricht
Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.
In collaboration with:
