Webinars

From guidelines to practice:
Meet 2026 regulatory expectations for your HCP-ELISA

November 12, 2025 by Ejvind Mortz, PhD

WATCH NOW

Regulatory agencies are raising the bar for Host Cell Protein (HCP) analysis, now expecting detailed ELISA coverage data, including proof of coverage of individual HCPs of concern.

Join us for a practical webinar where Ejvind Mørtz shares the latest insights on ELISA HCP coverage analysis by LC–MS, in alignment with the new US Pharmacopeia (USP) General Chapter <1132.1>.

In this webinar, you will get:

  • Recent updates from regulatory authorities (EMA, USP, ICH)
  • Best practices described in USP <1132.1> on ELISA HCP coverage analysis
  • Practical case studies featuring Alphalyse clients

Don’t miss these insights on CMC strategies to ensure regulatory-ready biologics development.

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