Cambridge Healthtech Institute’s 7th Annual
Cell Therapy CMC and Manufacturing
Optimise CMC, Analytical, and Manufacturing Strategies to Achieve Commercial Success
18-19 March 2025
Cambridge Healthtech Institute’s 7th Annual Cell Therapy CMC and Manufacturing conference brings together leading industry, academic, and technology experts to discuss recent advances in analytical characterisation, gene editing, CMC, and regulatory strategies. In-depth case studies will address the practical challenges faced during the scale-up and manufacture of cell therapies examining both autologous and allogeneic production platforms. Join us in Barcelona to learn how to enhance your product development processes and speed up time to market.
Coverage will include, but is not limited to:
- Regulatory considerations and quality control: What quality level do we need to reach at each stage of the clinical trial? What are the special considerations for cell therapies?
- EMA Substance of Human Origin: What does this mean for industry and how will it be implemented?
- Feedback on the new FDA guidance for allogenic cell-based products and safety testing
- CMC & emerging analytical methods: Issues with helper cells, fourier-transform spectroscopy, and cell analytics
- Assay development, characterisation, and validation
- Comparability strategies: Maintaining product comparability in accordance with EMA guidance, key considerations when setting up comparability studies for GM cells, how to validate methods, and reference standards for regulatory submissions
- Gene editing technology: CRISPR vs TALENs vs ZFNs
- Manufacturing processes: Point of care, scaling-up, and commercialisation, autologous manufacturing, allogeneic manufacturing, manufacturing equipment, automated closed systems, automated manufacturing devices, next generation production technologies, robust manufacturing methods, continuous improvement, process intensification, advanced process monitoring, biosensors, lean manufacturing, decentralized manufacturing
- In vivo CAR T—how will this impact manufacturing?
- AI, machine learning, and digitalisation in cell therapy manufacturing
- Formulation and aggregation strategies: Cryopreservation methods, high concentration protein formulations, Sub-Visible Particles (SVPs), and designing a stable liquid formulation
- Optimising technology transfer from small scale to large scale
- Supply chain and logistics: How to keep the drugs stable, temperature control strategies, and cold chains
The deadline for priority consideration is Friday 13 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: