Cambridge Healthtech Institute’s 11th Annual
SYMPOSIUM: Cell Therapy Analytics
Rapid Release, Robust Control, and Advanced Characterization of Cell Therapies
August 10, 2026
Cambridge Healthtech Institute’s 11th Annual Cell Therapy Analytics conference explores the standards, strategies, and technologies essential for rigorous CMC, release testing, and analytical control of cell-based therapies. Highlights include regulatory insight and interpretation of recent guidance, case studies on CMC pitfalls and potency assay development, guidance on raw and starting-material characterization, and effective tech transfer to GMP. The agenda also covers rapid release testing, identity and sterility methods, analytical reference standards, flow cytometry and automation, and emerging tools such as NGS and mass spectrometry. Case studies demonstrate practical solutions for robust product and process characterization across advanced therapy modalities, including ex vivo and in vivo CAR T applications.
Coverage will include, but is not limited to:
CMC Strategies and Standards for Cell-Based Therapies
- Regulatory updates and advice on cell therapies
- CMC pitfalls when developing novel cell-based therapies—case studies
- Update from NIST: Establishing fit- for-purpose cell viability assays
- Translating products from academia to commercial—tech transfer, due diligence, tech transfer
- Control strategies at commercial scale
- Raw material, starting material characterization, analysis and supply
Release Testing and Quality Control for Cell Therapies
- Update from USP on sterility and microbial testing chapter
- Development and adoption of rapid release tests for cell and gene therapy products
- Identity, purity and sterility testing, mycoplasma testing
- Particulates in cell therapies
- Bioburden Testing
Potency Assays, Product and Process Characterization
- Potency assay development—design of experiments, assay structure, robustness, statistical analysis, validation, defining MoA, expectations vs. reality
- Flow cytometry in QC of cell therapy, validating across multiple sites, cell counting. Automated approaches
- Reference standards for analytical assay development—opportunities and challenges during development and validation
- Analytical strategies for cell-based therapies—in-process analytics, automation, cell counting
Next-Generation Analytics for Advanced Therapies
- Mass spectrometry for cell-based therapies
- Next generation sequencing (NGS) for cell therapies
Analytics for in vivo CAR T
The deadline for priority consideration is January 23, 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: