Phlow Corp., a U.S.-based essential medicines public benefit company, has entered alliances with both Virginia Commonwealth University’s (VCU) Medicines for All Institute and AMPAC Fine Chemicals to provide contract continuous manufacturing research and development (R&D) services for small molecule pharmaceutical products. In addition to its internal capabilities, Phlow’s network of established partners will provide high quality, U.S.-based advanced manufacturing solutions for small molecule active pharmaceutical ingredients (APIs) and registered starting materials (RSMs) across all stages of development using state-of-the-art technologies.

Phlow’s Continuous Care consultation is an ideation model that provides differentiated pharmaceutical product R&D services, including laboratory services, route scouting and process intensification, laboratory proof of concept and cGMP kilo and large-scale manufacturing services. In addition to existing facilities and capabilities, Phlow is completing construction of highly automated manufacturing facilities and a bench scale R&D laboratory facility which will be located adjacent to its partners, VCU’s Medicines for All Institute and United States Pharmacopeia (USP).

“We’re thrilled to offer customized, advanced API and RSM research and development services to help other pharmaceutical and biotech companies in their development of medications for Americans by using flow chemistry and advanced manufacturing to catalyze positive change,” said Eric Edwards, co-founder, president and CEO of Phlow. “Together with our partners, it is Phlow’s goal to provide valuable insights and state-of-the-art processes to other companies in support of delivering high quality, improving yields, reducing costs, and sustaining our environment in the pharmaceutical industry.”

In addition to Phlow’s alliances with VCU’s Medicines for All, AMPAC Fine Chemicals and USP, Malcolm Berry has signed an agreement to join Phlow’s R&D team as a senior consultant. Dr. Berry is a leader in the field of continuous processing for small molecules, whose work includes the development of the world’s first multistage continuous production platform, as well as the lab-based technology and a workflow for developing continuous API processes. In his new role, Dr. Berry will be using his network and expertise on continuous manufacturing to enable peer-to-peer collaboration and the development of customized solutions.

VCU’s Medicines for All Institute and AMPAC Fine Chemicals have been working closely with Phlow since May 2020 in support of Phlow’s contract with the U.S. government to develop APIs using advanced and innovative processes. Under the new agreements, VCU’s Medicines for All Institute, a pioneer in flow chemistry and other continuous advanced manufacturing processes, will provide research and development support to Phlow as a preferred strategic partner for certain small molecule pharmaceutical products. AMPAC Fine Chemicals, a custom manufacturer of APIs, will provide scale up and commercial contract advanced manufacturing services, including continuous, to Phlow’s research and development clients.

“By expanding our current partnership with Phlow to service the commercial sector, we are creating a unique ecosystem between industry and academia that brings the best minds in advanced pharmaceutical development and manufacturing together to solve a problem where there is an unmet need,” said Frank Gupton, co-founder of Phlow, chair of Virginia Commonwealth University’s Department of Chemical and Life Science Engineering and CEO of the Medicines for All Institute. “Flow chemistry is an innovative, low-cost manufacturing platform that we need to introduce to other pharmaceutical companies in the U.S.”

Jeffrey Butler, president, AMPAC Fine Chemicals, said, “We are excited to continue working with Phlow, VCU’s Medicines for All Institute and our other partners in the development of pharmaceutical products here in the U.S. We are proud of what we are doing in Virginia with this transformational strategic alliance and are continuing to make the Virginia Gateway region home to an innovative, end-to-end, advanced manufacturing campus.”

Under an agreement announced in February 2021, USP, an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, is building a new laboratory co-located with the R&D laboratories at Phlow and VCU’s Medicines for All Institute that will develop test methods and standards for continuous manufacturing. This work will aid product development, tech transfer and drug application filings using continuous manufacturing to foster wider adoption of continuous manufacturing by generic-drug and other pharmaceutical manufacturers. The anticipated impact of the alliance includes the development of early scientific guidelines for high-quality continuous manufacturing processes.

“Pharmaceutical continuous manufacturing (PCM) poses several advantages over traditional batch manufacturing, especially during supply disruptions. These include the availability and use of real-time data to accelerate manufacturing scale-up and help improve medicine quality, enabling more efficient and nimble production of essential medicines and strengthening the overall supply chain,” said Ronald Piervincenzi, CEO, USP. “In addition, we hope that USP’s work with Phlow will help pave the way for the pharmaceutical industry to apply continuous manufacturing more broadly for the generic medicines so many patients rely upon.”