Advanced ELISA-MS™ for Host Cell Protein (HCP) coverage and ELISA Antibody Characterisation

Event Overview

This presentation showcases advanced ELISA-MS™ as the premier technology for detailed characterisation and comprehensive coverage of Host Cell Protein (HCP) ELISA reagents. Precisely assessing HCP coverage is essential for biopharmaceutical development and regulatory filing (e.g., IND/BLA).

Traditional methods often lack the specificity and quantitative accuracy needed. ELISA-MS™ addresses these issues by combining direct immunocapture in the ELISA well with LC-MS analysis to measure protein-antibody interactions under conditions that closely resemble the final ELISA test.

Key Learning Outcomes

• Learn about the pros and cons of the ELISA coverage methods outlined in USP 1132 and 1132.1
• Learn how ELISA-MS supports your bridging studies between ELISA reagent batches and compare commercial HCP-ELISAs to choose the best fit for your process
• Real-world case studies showing how Alphalyse clients have applied LC-MS-based ELISA coverage analysis to meet regulatory demands

What you need to know:

Dual-time broadcast, with starting times as follows:

Wednesday, 17 June 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
• Moving HCP LC-MS analysis into a GMP environment