Open Or Closed? How To Find The Right Balance In Cell Therapy Manufacturing

By Krishnendu Khan Senior Scientist, R&D

The demand for cell-based therapies, specifically chimeric antigen receptor (CAR) therapies for cancer treatment, is growing rapidly. However, the small production scale and high costs associated with these therapies make it challenging to meet the increasing demand. In order to address this issue, scientists are working on developing allogeneic cell therapies that can be mass-produced, yet this requires a complete overhaul of the manufacturing process.

Currently, closed fill-finish systems are being used for autologous CAR therapies. These systems provide a controlled and sterile environment, ensuring the safety and efficacy of the therapy. However, they are costly and have limited scalability. On the other hand, open fill-finish processes, similar to those used for monoclonal antibodies, offer more flexibility but come with increased risks of contamination.

The choice between closed and open fill-finish systems depends on several factors, including safety, accessibility, efficacy, and the specific type of cell therapy being used. Researchers and clinicians need to carefully consider these factors in order to determine the most appropriate packaging strategy for their specific therapy.