Developing a Cell Therapy cGMP Program for Early Phase Trials within a Hospital Setting


Topic:

Clinical Trials

Poster Number: 450 V

Author(s):

Tatyana Matveeva, PhD, Mass General Hospital

Neurodegenerative conditions are prevalent and devastating diseases with severe economic, personal, and healthcare expense consequences. Cell replacement therapies have offered a route to functional recovery, but clinical cell manufacturing frequently requires distributed production and oversight associated with substantial financial burden. The present report will outline an in-hospital cGMP cell manufacturing facility with adjacent quality control and in direct proximity to patients, and demonstrate the challenges of developing a compliant and all-inclusive program at cost.