The Central Role of Manufacturing for Complex Biologic Products

Cell and gene therapies are complex biologic products that continue to illustrate the longstanding adage that for biologics the process defines the product. Advancing manufacturing technologies for rapid scale up when large quantities of product are needed and for efficient throughput when small batches are required will be critical moving forward. Use of process automation, real time multiparametric in-line monitoring, and artificial intelligence, among other innovative technologies, may all combine to result in higher quality products produced with notably greater efficiency and at a lower cost. These advances will be particularly important in gene therapy for rare diseases, where the automation of small batch production of high-quality products is likely to be transformational. FDA will continue to advance the research and development of innovative manufacturing technologies while working to make a difference in public health.