Phlow Corp., a U.S.-based essential medicines public benefit company, announced strategic 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 robust and growing internal capabilities, Phlow’s network of established, innovative, and experienced strategic 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 and unique industry insights.
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 & 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 our 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, M.D., Ph.D., 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, Dr. Malcolm Berry has signed an exclusive agreement to join Phlow’s R&D Team as a Senior Consultant. Dr. Malcom Berry is a world-renowned 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.
“Phlow is creating a platform that is unique and differentiated in the industry,” said Dr. Malcolm Berry, Senior Consultant at Phlow. “From firsthand experience I know that operating continuously will enable the management of quality in real time and through the exquisite control of reaction parameters bring about a reduction in manufacturing variance, which is great news for patients.”
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 trailblazer 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 world leader and 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, Ph.D., 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.”
“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.,” said Jeffrey Butler, PhD, President of AMPAC Fine Chemicals. “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, the leading 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 T. Piervincenzi, Ph.D., CEO of 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.”
Through a public-private partnership with the U.S. Government, Phlow has demonstrated proof of concept that its novel continuous platform is revolutionizing small molecule API development. Specifically, Phlow has delivered an essential medicine API to the U.S. Government and successfully transferred several additional critical APIs to manufacturing for scale up. In 2021, Phlow became part of the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) Contract Development and Manufacturing Organization Network, established to provide domestic API capability for essential medicines and medical countermeasures. Additionally, Phlow received the HHS, Office of Small and Disadvantaged Business Utilization (OSDBU), Small Business Prime Contractor of the Year Award in 2021 for excelling in contract performance. Phlow is proud to have been accepted into the FDA Emerging Technology Program for the development and continuous manufacturing of APIs.
Together, Phlow and the U.S. Government are securing the nation’s supply of essential medicines and medical countermeasures by leveraging continuous flow and advanced manufacturing technologies. Under this historic partnership, Phlow is constructing the infrastructure and performing the R&D to create a resilient, U.S.-based, end-to-end essential medicine supply chain. Recognizing the importance of long-term sustainability, and consistent with Phlow’s Commercial Sustainability Plan submitted as a part of the U.S. Government contract award, Phlow is committed to becoming self-reliant and maximizing the government’s investment. The provision of innovative continuous manufacturing R&D services for small molecule pharmaceutical product development in the commercial sector is an important step towards delivering on Phlow’s commitment.
Phlow Corp. is a U.S. -based innovative essential medicines impact company that is reimagining the essential medicine supply chain through innovation in how these medicines are manufactured. Founded in 2020, Phlow is committed to securing the nation with a predictable and stable domestic supply of essential medicines. Phlow is working to establish a resilient end-to-end solution that is U.S.-based, comprehensive, and fully integrated so no patient visits a hospital to find out that the medicine they need is not available. With the support of an exceptional team, experienced strategic partners, and established relationships at the policy, regulatory, and federal levels, Phlow will manufacture APIs and finished pharmaceutical products domestically for essential medicines critical to the future of healthcare. Using state-of-the-art green chemistry, continuous flow technology, and other advanced manufacturing processes, Phlow is able to reduce costs and waste, improve quality and yield, and offer a more environmentally friendly alternative to batch manufacturing.