Event Overview
Some products, such as advanced therapies and vaccines, are too complex to produce suitable antigens for generating ELISA antibodies for HCP analysis. Moreover, developing process-specific ELISA assays can be very time-consuming and costly.
GMP-compliant mass spectrometry (MS)-based analysis of host cell proteins offers an alternative as a release assay during Phase 3 and commercial production. It provides a flexible, cost-effective tool that can be developed more quickly while still offering the high coverage and sensitivity needed for a reliable assay.
This discussion will cover key considerations for implementing GMP-compatible LC-MS methods as release assays and highlight successful cases where this approach has replaced traditional ELISA methods.
Key Learning Outcomes
- Understand the basic requirements of a GMP-compliant LC-MS method for HCP analysis
- Considerations in implementing an assay in line with USP 1132.1 and ICH guidelines
- See some real-world case studies where this has been applied as an ELISA alternative.
What you need to know:
Dual-time broadcast, with starting times as follows:
Wednesday, 15 April 2026
- Broadcast #1 (Europe / Asia): 10:00 h BST (London) / 11:00 h CEST (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:
- Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data
- Advanced ELISA-MS™ for Host Cell Protein (HCP) ELISA Antibody Characterisation – coming!
Presenters / Panellists
Thomas Cofoed, PhD
CEO
Alphalyse (Denmark)
Further presenters/panellists to be confirmed.
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:
