Raw materials are among the most critical, and often underestimated, factors influencing the success of a cell therapy program. Decisions made during early development can have significant downstream consequences for manufacturing scalability, process robustness, regulatory compliance, cost of goods, and ultimately patient access.

This interactive expert workshop is designed to provide participants with a practical understanding of raw material strategy, qualification, and management within cell therapy development. Rather than focusing solely on regulatory requirements, the workshop explores the broader mindset behind raw material decision-making and how these choices influence the entire product lifecycle.

Drawing on extensive industry experience, the workshop covers key topics including raw material selection, supplier qualification, scalability considerations, GMP transition, risk assessment, change management, and future regulatory expectations. Participants will gain insight into common challenges encountered during development and learn how to identify and mitigate potential bottlenecks before they become costly technical or regulatory obstacles.

The session is highly interactive and intentionally limited in size to encourage discussion, questions, and exchange of experiences. Real-world examples and practical perspectives are used throughout to bridge the gap between theory and implementation.This workshop is particularly relevant for professionals who are new to raw material qualification and management in ATMP development, those collaborating with raw material specialists, and anyone seeking a clearer understanding of how material-related decisions impact the successful development and manufacture of cell therapy products.
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MEET THE EXPERTS:

Michael W. Christiansen
CMC & GMP Manufacturing Expert with extensive experience leading cell therapy development programs from research through clinical manufacturing, technology transfer, GMP implementation, and commercialization.

‍Marta Grifell
Materials Strategy & Qualification Expert with experience in Cell Therapy and ATMP development. Her expertise includes starting materials, material qualification & risk assessment, supplier communication, GMP transition strategies, and materials QMS systems, with a strong focus on helping companies anticipate future manufacturing and regulatory bottlenecks.
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Participants will receive a Certificate of Participation issued by Nordic Cell Therapy Group following completion of the workshop.

Secure registration via our partner platform Gumroad.