Fill-Finish in Cell & Gene Therapy

As pharma’s therapeutic toolbox continues to evolve, cell and gene therapies (CGTs) are beginning to reach patients at commercial levels. Produced in unique settings—including small, clinical-scale manufacturing operations, dedicated facilities in hospitals, and shared clinical/processing environments—these advanced personalized therapeutics require highly integrated supply chains. These incumbent complexities can pose significant challenges in compliance with current Good Manufacturing Practices (cGMP).

Advanced Therapies on the Horizon, Processing Innovation Required

According to The American Society of Gene & Cell Therapy (ASGCT), there are 3,366 gene and cell therapies in development from the preclinical through pre-registration stages as of Q3 2021.¹ Globally, there are 19 gene therapies (including genetically modified cell therapies), 15 RNA therapies and 54 non-genetically modified cell therapies approved to date.

As with any rapidly growing field, there are mounting challenges for both innovators and their manufacturing partners in building out the commercial process.^2,3 Expanding capacity to add