Cambridge Healthtech Institute’s 8th Annual

Cell Therapy CMC and Analytics

August 14-15, 2023

Cambridge Healthtech Institute’s Cell Therapy CMC and Analytics conference focuses on the characterization, control, and quality of cell-based therapies, supported by in-depth case studies and insight from leading industry and academic representatives. Topics include CMC regulatory requirements, product and process characterization, potency assays development, quality of starting materials, and commerical scale challenges, with examples coming from the fields of CAR Ts, CAR-NKs, IPSCs, gamma deltas and TILs.

Coverage will include, but is not limited to:

Standards and regulatory expectations
Analytical methods for gene edited cell-based therapies
Manufacturing strategies for gene edited cell-based therapies
CMC strategies for cell-based therapies – preclinical to Phase III
Digitalization and AI in cell therapy analytics
Lifecycle management
Raw materials and adventitious agent testing
Monitoring quality across the process
Process analytics for cell therapies
Comparability strategies following process change – late-stage, post-approval, tech transfer
Quality control
Process development
In-process controls – rapid sterility testing
Formulation

The deadline for priority consideration is February 3, 2023.

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: