By Derek Pendlebury, Colder Products
Recent FDA approvals of the first cell and gene therapies (CGTs) are cause for celebration — but the marathon is not done. Attention has quickly turned to conquering the challenges of commercial-scale manufacturing for these promising therapies. Many of the current CGT manufacturing processes used to supply clinical trials are inadequate for commercial scale. Fortunately, some learning can be adopted from bioprocessing, a process with similar needs.
Understanding The Needs Of CGT Manufacturing
The pipeline of CGTs is impressive. In addition to the recent FDA approved therapies, over 400 therapies1 are in preclinical to Phase 3 development and approximately 1,700 clinical studies are underway globally.