Cambridge Healthtech Institute’s 12th Annual

Optimizing Bioassays for Biologics

Successful Bioassay Development in an Era of Emerging Therapeutic Modalities

October 17-18, 2024

New therapeutic modalities, including cell and gene therapies, immunotherapies, antibody therapies, and drug conjugates, continue to push the need for better testing and improved bioassay development. Many of these formats present new challenges. Cambridge Healthtech Institute’s 12th Annual Optimizing Bioassays for Biologics conference brings together speakers from industry and academia working in bioassay development, bioprocessing, and bioanalytics. This forum educates new and up-and-coming scientists entering the field by showcasing cutting-edge case studies and discussing how US and global 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:

Bioassay standards and reference reagents
Leveraging assays for product characterization, comparability, lot release, and stability
Bioassays for novel therapeutic modalities, such as cell and gene therapies, immunotherapies, and antibody therapies
Lifecycle management of biologics
Bioassay design and optimization and potency assay development
Similarity measures for bioassay acceptance
FDA’s potency assurance for cellular and gene therapy products draft guidance
Technical challenges in bioassay development
USP 1033 bioassay validation revision
Bioassay Quality-by-Design (QbD)
Non-traditional and innovative assay approaches

The deadline for priority consideration is April 5, 2024.

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: