WEBINAR SERIES
Qualification of Host Cell Protein ELISA and Phase-specific HCP Strategy
28 October 2026 | With expert from Cygnus Technologies | Better understand the advantages and limitations of Host Cell Protein (HCP) ELISA.
Event Overview
HCPs constitute a major group of process-related impurities in biological drugs and are a significant component of a biopharmaceutical drug developer’s overall risk-management strategy. HCP analytics have come a long way over the last 25 years. We have moved from a “black box” approach that produced numbers that were semiquantitative at best to groundbreaking Mass Spectrometry techniques that can identify every host cell protein in a Drug Substance sample.
Today, HCP ELISA remains the gold standard for HCP detection, and while still semi-quantitative, it is by no means a black box. We now have the tools to know exactly which HCPs the assay can detect and which ones it will miss. We will discuss how adopting advanced technologies and methods for HCP analytics ensures that an HCP ELISA, whether generic or process-specific, is appropriate for use and enables data-driven risk assessment to safeguard drug product integrity and safety.
Key Learning Outcomes
- How have HCP analytics advanced significantly over the past 25 years, evolving from limited, semi-quantitative methods to mass spectrometry techniques capable of identifying individual HCPs in drug substance samples?
- Learn why HCP detection and control are essential parts of biopharmaceutical risk management.
- Understand the advantages and limitations of HCP ELISA.
- Gain insights into advanced HCP analytical methods that verify whether generic or process-specific ELISA assays are fit for purpose, enabling data-driven risk assessment to support drug quality, integrity, and patient safety.
What you need to know:
Tri-time broadcast, with starting times as follows:
Wednesday, 28 October 2026
- Broadcast #1 (Europe / Asia): 10:00 h GMT (London) / 11:00 h CET (Paris/Berlin) / 15:30 h IST (New Delhi) / 18:00 h SGT (Singapore)
- Broadcast #2 (North America / Europe): 08:00 h PDT (Los Angeles) / 11:00 h EDT (New York) / 15:00 h GMT (London) / 16:00 h CET (Paris/Berlin)
Thursday, 29 October 2026
- Broadcast #3: (Asia / Pacific) 10:30 h IST (New Delhi) / 13:00 h SGT (Singapore) / 14:00 h JST (Tokyo) / 14:00 h KST (Seoul) / 16:00 h AEDT (Sydney)
Duration: Approximately 60 – 90 minutes, incl. Q&A.
Who should attend?
- Director of Analytical Development
- CMC Lead
- Analytical Development Technical Lead
- CMC Consultants
- Regulator Reviewers
Related events as part of the webinar series
Register your interest now:
- HCP Immunoassay Development: facts and myths – Coming soon
- Individual HCP Quantification by LC–MS: State of the Art and Challenges – Coming Soon
Presenters / Panellists
Eric BishopVice President, Research & DevelopmentCygnus Technologies (USA)Eric leads the research and development team and is responsible for new product development and custom development services. Eric has over 25 years of experience in HCP analytics. Eric joined Cygnus Technologies in 2010, Eric worked for AstraZeneca, formerly MedImmune, from 2002-2010. During his time there he had multiple roles from HCP assay development and tech transfer to being Analytical Representative on CMC teams guiding projects from IND to BLA submissions as well as Head of New Technology Development group. Prior to AstraZeneca, he was at CropTech Development from 1998-2002, where he was involved in characterization of recombinant proteins produced in plants.
Eric BishopVice President, Research & DevelopmentCygnus Technologies (USA)Eric leads the research and development team and is responsible for new product development and custom development services. Eric has over 25 years of experience in HCP analytics. Eric joined Cygnus Technologies in 2010, Eric worked for AstraZeneca, formerly MedImmune, from 2002-2010. During his time there he had multiple roles from HCP assay development and tech transfer to being Analytical Representative on CMC teams guiding projects from IND to BLA submissions as well as Head of New Technology Development group. Prior to AstraZeneca, he was at CropTech Development from 1998-2002, where he was involved in characterization of recombinant proteins produced in plants.
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Moderators
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.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.
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