Article | November 15, 2024

Streamlined Cell Therapy Development: Part II

Source: Kincell Bio

By Dr. Bruce Thompson

GettyImages-1294339649 drug development, cleanroom

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.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Bioprocess Online? Subscribe today.

Subscribe to Bioprocess Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Bioprocess Online