Continuous Manufacturing and its Regulatory Challenge

So, what is the buzz about continuous manufacturing (CM)? What benefits does it bring to the manufacturer and what are the regulatory challenges? The author of this Contract Pharma article, José L. Toro, Ph.D. of Lachman Consultants, discusses the current thinking on the benefits of CM and the regulatory hurdles a manufacturer has to overcome.

In summary, CM can provide quicker response to demand, potential reductions in manufacturing cost, and facilities investments. Also, reduction in Work in Progress inventories are conceivable, the ability to reduce production cycle times, and improved quality of the finished product can be achieved by reducing the manipulation of intermediates. The FDA is open to emerging technologies and has issued recent guidance documents that provide those of us interested in the industry to consider and implement this technology in our operations. Automation, understanding your process by using a comprehensive QbD approach, and the patience to potentially expect prolonged approval cycles can ultimately give a better product to the patient and provide potential/significant manufacturing cost saving.