Experts Statements: Charlotte Wiles, Chemtrix
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?
Charlotte Wiles: Continuous manufacturing (CM) is gaining global importance, boasting improved process control and reduced operating costs, leading to increased manufacturing profits and competitive edge. One of the most significant challenges for CM has been a lack of publicity around the technology’s implementation industrially. This is changing with CMO’s/CDMO’s now promoting their capabilities as outsourcing partners for CM; but still, details on what is achieved – and how – are less routinely disclosed.
An often-underestimated part of introducing a new technology into a company is how to navigate the transition from its use in a project to a process. This means a shift from a chemists‘ domain to one led by chemical and mechanical engineers, then beyond to plant operators and quality personnel for product release. Our view is that a multidisciplinary approach is required to achieve the project goals of safe, efficient, cost effective manufacturing and should involve a mixed team from the outset, obtaining the much needed “departmental buy-in” to accept a “new way” of doing something.
Whilst benefits such as increased process safety, reduced energy consumption and waste generation are widely noted, gaps remain in how to translate these advantages into a clear business case – as a result, we saw in the past several process development activities prematurely stop. The future of CM as a production technique rests on appropriate training, awareness of the benefits it can bring, together with its implementation early in product and process development. It is vital that disciplines are combined to identify opportunities for process improvement when assessing use of CM for manufacturing capabilities. This is not a field looking to compete with batch and existing hardware but to complement it, through access to new processing possibilities. The fear of regulatory reluctance has become less of a barrier for companies in the past 5 years, with the US FDA publicly stating their support for CM – this has led to more early stage process development activity.
Recent global events will undoubtedly change the way we manufacture fine and specialty chemicals, through to APIs, with supply chain management favoring in-house local and distributed manufacturing models. When combined with PAT/model-based automation, modular and flexible CM will increase productivity in companies focused on complex formulated products such as pharmaceuticals, chemicals and personal healthcare products.
Cooperation, not competition, is key to successful application of emerging technologies! It does not need to be “batch or flow,” “R&D chemist vs. scale-up engineer” and you do not have to do this alone. We advise learning from the experience of those in the equipment and CDMO space further to accelerate implementation of CM.