Cambridge Healthtech Institute’s 7^th Annual

Cell Therapy CMC and Manufacturing

New Strategies to Support Commercialization

19-20 March 2024

CHI’s Cell Therapy CMC and Manufacturing conference brings together leading industry, academic. and technology experts who have agreed to highlight their experiences, share their advice, and present case studies on how your company can best address core CMC and manufacturing challenges, including: selecting appropriate technologies to enable process efficiency, autologous and allogeneic manufacturing strategies (including CAR Ts, NK cells, TCRs, TILs, MSCs, IPSCs and gamma delta T cells), impact of automation and AI, managing data, analytical trends, current regulatory guidelines and compliance, managing supply chain and logistics, and facility design considerations.

Coverage will include, but is not limited to:

Improving Process Efficiency: Managing starting materials, donor source limitations, allogeneic cell banking, end-to-end process automation, procurement strategies, raw material sourcing to ensure lot-to-lot consistency, implementing existing and testing next-generation production technologies.
Integrating Analytics: Adapting existing technologies to reduce processing time, growing application of flow cytometry, managing cytotoxicity, improving potency.
Data Management and Automation: Exponential growth in data collection, techniques to manage batches and improve data sharing, leveraging automation and AI to better understand and treat patients, automating data analytics, identifying process change patterns.
Manufacturing: In vivo strategies to support CAR T and beyond, latest advancements in technology, shifting autologous and allogeneic strategies, scaling autologous cells, GMP strategies.
De-Centralized Manufacturing: Point-of-care strategies, improving patient access, role of hospitals and cancer centers, reducing process time/product volume requirements, minimizing cryopreservation steps to avoid product loss, managing COGs to expand assess-ability.
Regulatory Compliance: Clarifying what is/isn’t allowed, managing individual regulatory expectations, understanding SOHO (Substances of Human Origin), country specific starting material guidance, updating the 2001 law.
Facility Design: Multi-modal design considerations.
Supply Chain and Logistics: Precuring raw materials to support scale, ensuring lot-to-lot consistency, secondary supplier strategy and management; post-covid opportunities and expectations, temperature control strategies and cold chains.

The deadline for priority consideration is Friday 22 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 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: