Cambridge Healthtech Institute’s 13th Annual

Optimizing Bioassays for Biologics

Successful Bioassay Development in an Era of Emerging Modalities

October 9-10, 2025

New therapeutic modalities, including cell and gene therapies, immunotherapies, and antibody therapies, continue to push the need for better testing and improved bioassay development. Now in our 13th year, CHI’s Optimizing Bioassays for Biologics conference brings together speakers from industry and academia working in bioassay development, bioprocessing, and bioanalytical. This forum educates new and up-and-coming scientists entering the field by showcasing cutting edge case studies and discussing how regulatory agencies view testing with novel modalities. Join us this October to hear novel bioassay approaches and how our expert speakers overcome the most common challenges in biological assay development, validation, transfer, and maintenance.

Coverage will include, but is not limited to:

Lifecycle management of biologics and new drug formats
Potency assay development
New modalities including cell and gene therapies, immunotherapies, oncolytic virus therapies, and antibodies
Developing and bridging reference standards
Regulatory considerations
Using automation in bioassays: When, where, and how to integrate
Designing assays to fit into a clinical workflow
In vitro assays for characterization
Bioassay control and maintenance
Bioassay Quality by Design (QbD)
Bioassays to understand a drug's Mechanism-of-Action (MoA)
Designing bioassays for biologics with multiple Mechanism-of-Action (MoA)
Assay bridging and analytical bridging
New bioassay technologies to increase speed and sensitivity

The deadline for priority consideration is March 28, 2025.

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: