In contrast to the traditional batch mode of production, manufacturing by Continuous Flow Process is fluid, offering a greener more environmentally-friendly alternative. Continuous Processing can lead to safer and more economical and scalable production, reducing costs, waste and cycle time to improve quality and yield.

However, manufacturing at small scale via continuous flow processing is usually hindered by the excessive lead time required to build dedicated and expensive small-scale units. AMPAC Fine Chemicals (AFC), an SK pharmteco company, has revolutionised continuous process manufacturing development through the use of a unique in-house modular approach.

These modules can produce multi-kilograms of material per day, which can be used for the initial scale-up production of clinical phase programs, as well as commercial drug products under cGMP. The modular units were developed by a cross-functional team at AFC’s Rancho Cordova Site. To close the gap between bench top development, using micro reactors, and manufacturing at scale using large, dedicated equipment, AFC has developed a library of modular units.

Each of these units is fully qualified and can be rapidly connected allowing for a highly customised reaction system that delivers the exact process conditions the chemistry requires. Increasing the number of units for specific demand (material of construction, extended pressure range, etc) can be done incrementally, providing a lower capital investment. In addition, the fact that the library of modules exists allows for a reaction system to be built over days rather than months to years.

The result is a highly efficient process that enables a company to generate cGMP APIs at small, medium and large volume without incurring costs for high volumes of raw materials or large fixed assets. Finally, when the process is demonstrated, upscaling to larger dedicated continuous units is straightforward.

This innovative approach changes the landscape for continuous manufacturing by allowing early clinical phase products to be manufactured at smaller scale, quickly and cost-effectively while delivering an optimised process that is easy to scale-up.

“Innovation within the SK pharmteco group of companies has always been a priority to benefit our customers,” stated Dr. William DuBay, Vice-President, Global Research & Development SK pharmteco. “The team of chemists and engineers at our workshop in California has changed how we approach continuous flow processing within SK pharmteco. This innovation ensures that the future of continuous flow processing is strong, but, more importantly, that we can manufacture essential medicines in the US for our customers at a controlled cost.”

Working with Phlow Corp, a U.S.-based innovative public benefit corporation that is reimagining the essential medicine supply chain and providing differentiated contract continuous research, development and manufacturing services (CDMO) for small molecule pharmaceutical products, the AFC team in California has demonstrated the value and effectiveness of this highly customised reaction system to efficiently manufacture a key API.

Andrew Carpenter, Executive Vice-President of Manufacturing, Science & Technology, Phlow Corp, said: “This modular system reduces time and cost in manufacturing and is an integral part of our effort to develop and manufacture essential medicine APIs through advanced, continuous methods. We are proud to be partnered with the AFC team2”.