Streamlined Cell Therapy Development: Part I

By Dr. Bruce Thompson

Product development in cell therapy presents unique challenges for CDMOs (Contract Development and Manufacturing Organizations) and their clients, who aim to deliver the highest quality product in the shortest time and at the lowest cost. Early program decisions—such as whether to opt for a "quick-to-clinic" approach or invest in a more scalable, commercial-ready process—can stall progress as teams struggle to balance competing priorities on the path from candidate selection to a successful commercial filing.

Early collaboration between research and development teams is critical in navigating these decisions. Though "research and development" is often seen as a unified function, it actually encompasses two distinct goals: discovery and process optimization, which can lead to missed opportunities for mitigating future development challenges. Involving a development partner early on, particularly by incorporating "manufacturability" considerations into the target product profile (TPP), helps ease the transition from research to later-stage preclinical development.

To streamline this process, organizations can apply guiding principles and stage-gates that break down the development journey into more manageable steps. This approach allows innovators to prioritize decisions, conduct risk assessments, and address key aspects of the product’s process and control strategy at the right moments. By treating development as a series of milestones, teams can plan mitigation strategies and align their efforts with the product’s lifecycle in advance.

This article, the first in a two-part series, focuses on the initial stages of product development—specifically, how to move from candidate selection to a Phase 1 Investigational New Drug (IND) application. Part II will explore process and analytical optimization activities, including strategies for reducing risk, ensuring comparability, and minimizing execution challenges as the product moves toward commercialization.