Cambridge Healthtech Institute’s 14th Annual
Optimizing Bioassays for Biologics
Precision Potency and Control Strategies for Next-Generation Biotherapeutics
October 21-22, 2026
As biologics expand into genome editing, mRNA, autologous cell therapies, and complex immunotherapies, bioassay expectations continue to evolve. Now in its 14th year, CHI’s Optimizing Bioassays for Biologics brings together industry and academic experts to share practical case studies, statistical strategies, and regulatory insights for developing, validating, and maintaining robust potency assays. Join us this October to explore innovative approaches that align bioassays with mechanism-of-action, clinical relevance, and lifecycle control from early development through commercialization.
Coverage will include, but is not limited to:
- Potency assay development for complex and multi-modal biologics
- Bioassay strategies for mRNA, genome editing, plasmid, and autologous cell therapies
- Designing assays aligned to mechanism-of-action (MoA) and clinical relevance
- Establishing and qualifying potency-related critical quality attributes (CQAs)
- Reference standards, reagent qualification, and measurement assurance strategies
- Statistical considerations for bioassay monitoring, acceptance criteria, and tolerance intervals
- Managing variability in autologous and patient-derived products
- Regulatory expectations for phase-appropriate validation and lot release criteria
- Bioassay control, lifecycle management, and statistical process control in complex datasets
- Integrating automation, robotics, and digital workflows into cell-based assays
- AI, machine learning, and deep-learning applications in bioanalysis and assay optimization
- Immunogenicity risk assessment and mitigation by design in biologic development
The deadline for priority consideration is April 10, 2026.
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
Opportunities for Participation: