Continuous Manufacturing: An Evolving Technology For Drug Substance Manufacturing

Continuous manufacturing (CM) technology is revolutionizing the pharmaceutical industry. Initially used in the production of high-volume commodity chemicals, CM has now found its way into drug manufacturing. The Novartis-MIT Center for Continuous Manufacturing and the FDA's Emerging Technology Program have played key roles in promoting the adoption of CM in the pharmaceutical sector.

Three specific areas have emerged where CM has proven successful: high-temperature reactions, photochemistry, and membrane technologies. In high-temperature reactions, tubular reactors have been employed to facilitate extreme conditions and obtain desired isomers of late-stage intermediates. Photochemistry, an essential tool in medicinal chemistry labs, has also been scaled up successfully, with photoreactors designed to maintain similar photophysics from lab to production-scale. Membrane separation techniques, including tangential flow filtration and pervaporation, have been utilized to drive equilibrium and selectively remove by-products in drug manufacturing.

CM is becoming increasingly integrated with batch processing, resulting in a hybrid manufacturing process. As the complexity of synthetic drug substances continues to rise, the adoption of CM technology will only continue to grow and evolve. By overcoming technical challenges and providing more efficient and cost-effective solutions, CM is poised to transform the pharmaceutical industry. Learn more about the exciting developments in CM technology and how leveraging this innovative method can help improve manufacturing processes and discover new clinical candidates.