UPCOMING WEBINAR SERIES
Advanced ELISA-MS™ for Host Cell Protein (HCP) coverage and ELISA Antibody Characterisation
17 June 2026 | With experts from Alphalyse
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 PDT (Los Angeles) / 11:00 h EDT (New York) / 16:00 h BST (London) / 17:00 h CEST (Paris/Berlin)
Duration: Approximately 60 – 90 minutes, incl. Q&A.
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
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Presenters / Panellists
Anette Draborg, PhDSubject-matter expert in ELISA characterisationAlphalyse (Denmark)Anette Draborg, PhD, is a subject-matter expert in ELISA characterisation at Alphalyse, where she applies her extensive research experience in immunology and immunochemical assay development to support biopharmaceutical clients. She specialises in ELISA-MS™ coverage assessment, which combines immunocapture with liquid chromatography-mass spectrometry (LC-MS) to assess the suitability of ELISAs for Host Cell Protein (HCP) detection and control. Since joining Alphalyse in 2021, Anette has helped numerous clients evaluate the performance of their HCP-ELISAs using ELISA-MS™, ensuring fit-for-purpose assays that meet regulatory expectations and support the development of safe biologics.
Ejvind Mørtz, PhDCo-Founder & COOAlphalyse (Denmark)Ejvind holds a PhD from the University of Southern Denmark in Protein Chemistry & Molecular Biology. He has more than 20 years of experience developing protein analyses and mass spectrometry methods in the research & development of protein biologics, vaccines, monoclonal antibodies, therapeutic proteins, and cell and gene therapies.
Søren Skov Jensen, PhDAssociate DirectorHemab Therapeutics (Denmark)Søren Skov Jensen, M.Sc., PhD, serves as Associate Director, CMC Analytical Development at Hemab Therapeutics. He has over 14 years of experience in the biotechnology industry and has worked on therapeutics ranging from peptides to proteins and monoclonal antibodies across early- and late-stage development. Søren holds a PhD in Biochemistry and Molecular Biology from the University of Southern Denmark.
Anette Draborg, PhDSubject-matter expert in ELISA characterisationAlphalyse (Denmark)Anette Draborg, PhD, is a subject-matter expert in ELISA characterisation at Alphalyse, where she applies her extensive research experience in immunology and immunochemical assay development to support biopharmaceutical clients. She specialises in ELISA-MS™ coverage assessment, which combines immunocapture with liquid chromatography-mass spectrometry (LC-MS) to assess the suitability of ELISAs for Host Cell Protein (HCP) detection and control. Since joining Alphalyse in 2021, Anette has helped numerous clients evaluate the performance of their HCP-ELISAs using ELISA-MS™, ensuring fit-for-purpose assays that meet regulatory expectations and support the development of safe biologics.Ejvind Mørtz, PhDCo-Founder & COOAlphalyse (Denmark)Ejvind holds a PhD from the University of Southern Denmark in Protein Chemistry & Molecular Biology. He has more than 20 years of experience developing protein analyses and mass spectrometry methods in the research & development of protein biologics, vaccines, monoclonal antibodies, therapeutic proteins, and cell and gene therapies.Søren Skov Jensen, PhDAssociate DirectorHemab Therapeutics (Denmark)Søren Skov Jensen, M.Sc., PhD, serves as Associate Director, CMC Analytical Development at Hemab Therapeutics. He has over 14 years of experience in the biotechnology industry and has worked on therapeutics ranging from peptides to proteins and monoclonal antibodies across early- and late-stage development. Søren holds a PhD in Biochemistry and Molecular Biology from the University of Southern Denmark.
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Moderators
Prof. Dr. Cari Sänger-van de GriendScientific DirectorBioQCExpert 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 TrichtScientific DirectorBioQCExpert 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.
Prof. Dr. Cari Sänger-van de GriendScientific DirectorBioQCExpert 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 TrichtScientific DirectorBioQCExpert 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.
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