GMP Compliant Manufacturing

With 16 years of direct accountability for clinical bioprocess manufacturing (hematopoetic stem cells, pancreatic Islet isolates, genome modified T-cells and activated dendritic cell vaccines, engineered vasculature) and three years consulting, Dr. Irwin has supported development and manufacturing of some of the most important biological products in recent history. He has consistently brought order to chaos as a subject matter expert for cell culture, cryopreservation, bioreactor/fermenter, chemical treatment, fill/finish, storage, shipping, and many more activities. Experienced with scale-up, optimization, tech transfer, and external process oversight.