Experts Statements: Shawn Conway, Cambrex High Point
Flow Chemistry: A Mature Technology still on the Rise
Flow chemistry or milli- and micro reaction technology (MRT) is a platform that can offer enormous advantages in this respect. But MRT has not yet achieved the status in fine chemicals and active ingredient manufacturing that one might expect. What are the reasons for this reluctance?
CHEManager asked executives and industry experts dealing with flow chemistry so share their opinion on why some industry sectors are so reluctant in adopting continuous production processes. We wanted to know:
Which factors are affecting the global flow chemistry market and the implementation of flow chemistry in the industry?
Shawn Conway: Batch production has traditionally been – and still is – the mainstay of the pharmaceutical manufacturing sector, largely due to quality and regulatory requirements. Continuous flow chemistry had typically been reserved for niche applications, such as highly energetic and/or hazardous reactions where continuous processing allows risks to be managed to avoid catastrophic events as well as expensive infrastructure requirements.
Flow chemistry has become more widely accepted throughout the pharmaceutical industry for several key reasons in addition to process safety, namely volume and cost, as well as quality and reduced development timelines. An increase in the number of highly potent and/or orphan drugs has led to a need for a nimble, smaller-volume capacity model. Existing large batch processing infrastructure is not well suited for these applications for both capability and cost considerations. Developing, designing and implementing modular flow chemistry platforms that can be customized serves this growing need in the industry.
Flow process scalability also allows for fewer scale-up cycles in a development lifecycle, reduces investment cost and speeds time to market for successful drugs. Furthermore, flow chemistry has been shown to provide superior quality for a range of challenging synthetic steps such as cryogenic organolithiations. The ability to tightly control the physical parameters has been shown to afford more consistent products with fewer impurities or unwanted by-products, which can reduce development efforts required to extract, isolate and purify target compounds. This provides a more efficient and streamlined process, and can also reduce timelines, material and energy requirements, enhancing process sustainability.
Recognizing these advantages, the pharmaceutical market has invested accordingly in the technologies, triggering a corresponding investment and growth of process development and equipment providers to enable these powerful technologies.