Day 1 Afternoon Workshop:
Streamlining Immunogenicity Assessment of Host Cell Proteins (HCPs): Insights and Case Studies
Workshop leaders:
Anne De Groot, EpiVax | Ben Gabriel, EpiVax | Marla Abodeely, Sanofi | Vibha Jawa, EpiVax
Host cell proteins, or HCPs, remain one of the most persistent challenges in biologics development. Advances in purification and analytics have significantly reduced overall HCP burden, but residual proteins can still pose immunogenicity risks with potential clinical consequences. As LC-MS makes it possible to identify and quantify individual HCP species, the key question is no longer “How much HCP is present?” but “Which HCPs matter?”
This workshop will explore how to move from reporting total HCP levels to implementing a risk-based, immunologically informed assessment strategy. We will examine the strengths and limitations of traditional ELISA approaches and LC-MS, and discuss how integrating these tools with in silico epitope analysis and targeted in vitro assays can help triage HCPs based on their true immunogenic potential. Participants will gain insight into how factors such as T cell epitope content, sequence similarity to human proteins, abundance, and clinical context influence risk.
Through practical examples and discussion, we will outline how orthogonal methods can support more targeted risk mitigation strategies, such as selective process optimization or focused removal of higher-risk HCPs. We will also address evolving regulatory expectations and how a scientifically grounded, context-specific rationale can strengthen submissions and facilitate productive agency dialogue.
Attendees will leave with a clearer framework for applying integrated HCP immunogenicity assessment across the development lifecycle, enabling more efficient decision-making and a stronger alignment between analytical data and clinical risk.
Speakers to be announced soon!
*Attendance of the Day 1 Workshops is only possible with the 3-Day Event registration to the BEBPA HCP Conference. This will be an in-person only event.
