Integrating iPSC-Derived Functional Models with Immunogenicity Assessment to De-Risk Antibody & Bioconjugate Candidates Earlier

Thursday, May 21st at 15:00 GMT | 16:00 CET | 10:00 EST | 07:00 PST

Late-stage attrition is one of the costliest problems in biotherapeutic development and one of the most preventable. Too many antibody and bioconjugate programs reach late preclinical or clinical stages with liabilities that could have been identified and addressed much earlier. The tools to do this exist, but the challenge is knowing how to deploy them effectively.

Two gaps that drive the problem:

• First, standard preclinical models routinely fail to capture how complex biotherapeutics behave in human immune tissue, leaving off-target immune activation or cytokine dysregulation undetected until it becomes a clinical finding.
• Second, immunogenicity risk assessment is still too often treated as a late-stage obligation rather than an early selection criterion, despite being a leading driver of attrition and post-approval withdrawal.

However, both gaps are addressable earlier than most programs attempt.

Join experts, Dr Sanne Holt (Associate Director, Immuno-Oncology, Ncardia) and Dr Erika Kovacs (Sr. Director of Bioassay, Abzena) on May 21^st, as they present a practical, case-based integrated approach to early safety assessment. Drawing on human iPSC-derived functional immune models, alongside in vitro immunotoxicity and immunogenicity evaluations, they will share key insights into the mechanistic understanding needed to make informed candidate selection decisions.

Key learning objectives

• Why conventional early safety tools leave predictable blind spots in antibody and bioconjugate development
• How iPSC-derived immuno-oncology models surface functional liabilities that standard assays miss
• How immunotoxicity and immunogenicity risk — using both in silico and in vitro approaches using primary human cells — can be assessed before IND-enabling studies
• How to combine these approaches into an integrated early safety strategy that reduces downstream attrition

Register to learn how to implement an integrated early safety strategy and assess how this approach could increase your biotherapeutics’ chances of clinical success.

Who should attend?

For discovery, translational, and preclinical scientists working on antibody and bioconjugate programs who want to improve early safety assessment and reduce downstream risk.

Speakers

With over 10 years of experience in immuno-oncology and translational research, Sanne specializes in advancing large molecules and cell therapies from early discovery to IND-enabling studies. At Ncardia, she manages a scientific team and drives innovation in efficacy and safety testing of novel drug therapies on human iPSC-derived cell models. Previously, she held leadership roles at Merus N.V. and Charles River Laboratories, where she managed cross-functional teams and delivered impactful research solutions. She holds a PhD from King’s College London and is passionate about supporting the translation of cutting-edge science into real-world therapies.

With over 19 years of pharmaceutical industry experience, she leads the Bioassay team at Abzena, supporting drug discovery and development efforts with cell-based assays for lead selection, characterization, potency, and safety. With her expertise in functional characterization and complex modes of actions, she is passionate about finding new modalities to fight cancer. Erika has a strong academic background, earning a PhD in Biochemistry from Eötvös Loránd University, Hungary, and completing a postdoc at the University of California, Berkeley, prior to joining Abzena.

About Abzena 

Abzena is a global life sciences company providing integrated services across the development of biologics and complex therapeutics, with facilities in the US and UK. The company focuses on supporting biopharmaceutical partners from early discovery through clinical development, combining antibody engineering, cell line development, and CMC expertise into a single, streamlined offering. Abzena’s goal is to reduce development risk and accelerate timelines by aligning scientific insight with scalable manufacturing strategies. For more information, visit www.abzena.com.