Streamlined Cell Therapy Development: Part II
By Dr. Bruce Thompson

Industrializing cell therapy is both exciting and complex. Innovators often face challenges balancing accelerated clinical timelines and regulatory requirements, leaving little room to optimize manufacturing later. Early decisions can profoundly impact commercialization, as misalignment between scientific exploration and commercial needs creates roadblocks. Research teams focus on answering scientific questions and expediting clinical progress, while commercial teams prioritize scalable, cost-efficient, high-throughput processes.
This disconnect, if unaddressed, can lead to significant process changes that may require comparability studies or even a new IND filing, delaying progress. Early alignment through thoughtful planning and integration of manufacturing strategies into the target product profile (TPP) is essential. Key considerations include assessing patient population and product attributes to design scalable processes, implementing a process optimization strategy to streamline development, and refining analytical controls to tighten specifications and elevate critical tests. Early, purposeful decisions lay the foundation for smoother transitions to commercialization and long-term success.
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