Avoiding slowdowns on the cell and gene therapy development pathway

Process development of cell and gene therapy (CGT) products, from their origins in academic research labs to licensure and commercialization, involves multiple technology transfer steps. This is a critical but often problematic transition step in the lifecycle of CGT products. The science underpinning many novel CGT products originates in academic research laboratories, but reaching commercialization requires transfer to industry, for process development and controlled manufacturing. Subsequent technology transfers—from process development to GMP manufacturing, from one GMP manufacturing site to another—take place between industry laboratories and facilities, i.e., industry-to-industry. The first transfer, however, is a transition between two distinctly different cultures, academic research-and-industry manufacturing, and so presents unique challenges.