Cambridge Healthtech Institute’s 8th Annual
Cell Therapy Manufacturing and CMC
Commercialising and Scaling ex vivo and in vivo Cell Therapies
10-11 March 2026
Despite notable clinical successes, the cell therapy industry continues to face significant cost pressures, suboptimal commercialisation strategies, and complex regulatory hurdles. CHI’s 8th Annual Cell Therapy Manufacturing and CMC conference will highlight the latest advances in production, quality, and delivery of these transformative therapies to patients.
Key themes include lessons learned from approved therapies, advancing centralized and decentralized models such as Point-of-Care, and the role of digital tools, AI/ML, automation, robotics, and digital twins in streamlining complex workflows and enabling real-time control. The program also highlights in vivo CAR T as a disruptive paradigm, covering vector design, regulatory considerations, and CMC implications.
Coverage will include, but is not limited to:
- Scaling & Commercialising Cell Therapies—learnings from approved products, scale-up strategies, centralised vs. decentralised models, and patient-centric manufacturing
- Investment Trends in Cell & Gene Therapies—funding outlook for 2026 and beyond
- Process Optimisation and Intensification for Gene-Edited therapies—enabling scalable and efficient manufacturing of complex gene-edited therapies
- AI, Digital Twins & Automation—real-time data acquisition, process simulation, and robotics integration in cell therapy production
- Automating Manual Operations—balancing efficiency gains with product quality in sensitive workflows
- CMC Strategies for Cell Therapies—QbD integration, critical quality attributes (CQAs), and control strategies
- Regulatory Perspectives—FDA platform technology guidance, MHRA POC manufacturing guidance, and EU ATMP regulation updates
- Analytical Advances—potency assay development, sterility/purity testing, and NGS for adventitious agent detection
- In vivo CAR T Manufacturing—paradigm-shift potential, CMC challenges, and vector-design considerations for LLVs and LNPs
- Safety & Regulatory Considerations for in vivo Delivery—addressing dosing, long-term monitoring, and risk mitigation
The deadline for priority consideration is Friday 12 September
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: