Leaders in Continuous Flow Processing Innovate to Increase Capability to Manufacture in Small Scale

Press Release: Immediate Release
Date: 26 October 2022

Leaders in Continuous Flow Processing innovate to
increase capability for small scale manufacture

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.”

About SK pharmteco and AMPAC Fine Chemicals

SK pharmteco is the single customer-facing team comprised of SK biotek Ireland, AMPAC Fine Chemicals, SK biotek Korea, Yposkesi and most recently The Center for Breakthrough Medicines. Creating substantial market synergies in the API and Cell and Gene Therapy CDMO space by combining highly complementary assets and expertise, this union enables us to provide the highest-quality services to our customers.
With world-class state-of-the-art facilities and technology, increased capabilities: energetic chemistry, continuous flow process, controlled substances, particle engineering, high potency – with world-class potent handling capability (down to low nanogram per cubic meter levels). We have multiple cGMP manufacturing and development sites, with ~1300m³ of capacity among 8 sites plus analytical services facilities across USA, Korea and Ireland.
SK pharmteco is a portfolio company of SK Inc. (South Korea) and serves as a strategic part of SK’s growing pharmaceutical sector. For more information, visit https://www.skpharmteco.com/.

AMPAC Fine Chemicals, an SK pharmteco company, is a US-based company with demonstrated capabilities in process development, scale-up, and CGMP-compliant commercial production of active pharmaceutical ingredients and registered intermediates for pharmaceutical and biotechnology customers.

AMPAC Fine Chemicals is a portfolio company of SK pharmteco, a US-based company with state-of-the-art facilities located across the US, Europe, and Asia.
AFC’s specially engineered facilities and experienced staff allow for the safe production of highly energetic compounds at commercial scale. In addition, AFC’s other technology platforms include production of highly potent compounds, continuous processes, industrial-scale chromatographic separation using simulated moving bed chromatography and analytical services to the pharmaceutical industry. AFC’s operations are in Rancho Cordova and El Dorado Hills California, La Porte Texas, and Petersburg Virginia.

Additional information about us can be obtained by visiting our website at www.skpharmteco.com | www.ampacfinechemicals.com

For further information or comment contact:
Patrick Park, VP Strategy and Business Development, SK pharmteco
Tel: +1 (916) 357-6376 Email: patrick.park@skpharmteco.com

For Interview Requests during CPhI Frankfurt contact:
Audraí O’Dwyer Global Marketing Communications Lead audrai.odwyer@skpharmteco.com

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