Realizing A New Approach To Allogeneic Cell Therapy Process Development

By Sara Miller, Associate Director, Cell Therapy Business Steering Group Lead, and Marie-Caline Abadjian, Senior Scientist, FUJIFILM Diosynth Biotechnologies

As cell and gene therapies continue to gain traction in the larger pharmaceutical development pipeline, innovations enabling more “off-the-shelf” advanced therapeutics are likewise gaining steam. Increasing investment in pursuing allogeneic therapies, alongside the process-level advancements necessary to achieve commercial scale, are paving the way for more streamlined, standardized cell therapy development and manufacturing.

Allogeneic cell therapies have the potential to greatly improve the economies of scale associated with cell therapy production when compared to the autologous cell therapies more commonly pursued today. By working to standardize the cell therapy process steps and tools common across both allogeneic and autologous applications, operators can enable greater speed and reduce the potential for error during later phases of development and scale-up. Balancing this standardization with the flexibility necessary to support unique assets and applications requires both expertise and experience in closing cell therapy processes. It also requires successfully navigating a new era in global cell therapy regulations and the skills and experience in dealing with regulatory authorities. For many biopharmaceutical companies, this necessitates identifying a contract development and manufacturing organization (CDMO) that can support process intensification comprehensively to help an asset achieve faster development and optimized scaling.