Process Development & Chemical Manufacturing – A View from the Regulators on Continuous Manufacturing

Whilst significant scientific advances in continuous manufacturing have been made, concerns have arisen as to the regulatory bodies views and acceptance of a change from ‘batch manufacturing to flow’. The message from the FDA is clear: “The FDA supports the implementation of continuous manufacturing using science and risk-based approaches”. The FDA stated that continuous manufacturing has the potential to ‘not only meet current expectations, but to really give enhanced product quality over what some of the current batch technology provides’. Continuous manufacturing offers the potential to move away from large-scale, capital intensive production installations towards decentralized, small scale units. This mode of operation has potential to reduce the time to market for breakthrough therapies, where accelerated timelines can be a challenge when planning to scale-up in batch, and response to outbreaks.