GMP Compliant Manufacturing

With nearly 20 years of direct leadership in clinical bioprocess manufacturing—including hematopoietic stem cells, pancreatic islet isolates, genome-modified T-cells, activated dendritic cell vaccines, and engineered vasculature—along with three years of consulting experience, Dr. Stuart Irwin has played a pivotal role in advancing some of the most significant biological products of our time.

Renowned for bringing structure to complexity, Dr. Irwin is a subject matter expert across a wide range of critical operations, including cell culture, cryopreservation, bioreactors and fermenters, chemical treatments, fill/finish processes, storage, shipping, and more. His expertise extends to scale-up, process optimization, technology transfer, and oversight of external manufacturing processes, making him an invaluable partner in developing and producing cutting-edge biopharmaceuticals.