SK pharmteco, Leaders in Continuous Flow Processing Innovate to Increase Capability to Manufacture in Small Scale 26th October 2022
SK pharmteco provides expertise in Continuous Processing and is a recognized world-leader in the development and manufacturing of custom cGMP Intermediates and APIs using Continuous Processes. AMPAC Fine Chemicals (AFC), an SK pharmteco Company, has revolutionized continuous flow process manufacturing development through a unique in-house modular approach. The modules can easily produce 20 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.
These modular units were developed by a cross-functional team at AFC’s Rancho Cordova Site. After identifying the need to close the gap between bench top development using micro reactors and the manufacturing scale using Continuous Flow Processing, AFC developed a library of modular units. Each of these units is fully qualified and can be rapidly connected allowing for a highly customized 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.
Continuous Processing can offer safer, greener, more scalable, and more economical options to batch manufacturing; however, manufacturing at small scale via continuous flow processing is usually hindered by the excessive lead time required to build dedicated and expensive skids. 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 optimized process easy to scale-up.
Dr William DuBay, VP Global Research & Development, SK pharmteco said ‘Innovation within the SK pharmteco group of companies has always been a priority to benefit our customers. 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 customized reaction system to efficiently manufacture a key API.
Andrew Carpenter, EVP of Manufacturing, Science & Technology at 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 team.”