By Per Hammer and Linda Lemieux
FDA’s current good manufacturing practice (cGMP) regulations are a critical factor in producing consistently safe and effective biopharmaceutical products. When a manufacturer is compliant with cGMP regulations, the process, facilities, equipment, and controls used to make the product will consistently produce a quality drug for human use. The regulations, 21 CFR Part 210 and 211, outline the minimum requirements for biopharmaceutical manufacturing. The regulations include controls over personnel, facilities, equipment, components, processes, testing, packaging, labeling, warehouse, and distribution. Traceability of these controls is a key aspect of ensuring compliance to all cGMP requirements.
As the landscape of the industry continues to grow and evolve, advanced therapies are now being produced in unique settings, including small-scale manufacturing facilities, hospitals, and translational facilities. They are also being developed using innovative processes, such as the genetic modification of a patient’s own cells. This creates significant challenges in cGMP compliance as these locations and processes may not be equipped to monitor and safeguard the manufacturing process. Even biomanufacturers with cGMP facilities outfitted for biologic production face obstacles when trying to ensure the stability, progression, and traceability of autologous cell therapies from the time cell material reaches their facility to when it leaves. Simplifying the day-to-day tasks of managing these cutting-edge, life-saving drugs and ensuring consistency in their production is vital to the future of the industry. Therefore, as automation continues to offer new possibilities in flexibility and optimized production in biomanufacturing, exploring its use in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance becomes a key factor in advancing patient care.