Research consultant

Phlow™ will provide innovative continuous manufacturing research and development services for the development of small molecule pharmaceutical products in the commercial sector

Phlow enters into agreements with Virginia Commonwealth University’s Medicines for All Institute, AMPAC Fine Chemicals and Dr. Malcolm Berry, PhD, joins the Phlow team to provide industry-leading expertise

RICHMOND, Virginia, March 21, 2022–(BUSINESS WIRE)–Phlow Corp., a U.S.-based essential medicines utility company, today announced strategic alliances with the Medicines for All Institute at Virginia Commonwealth University (VCU) and AMPAC Fine Chemicals to provide contract manufacturing research and development (R&D) services for small molecule pharmaceuticals. In addition to its robust and growing in-house capabilities, Phlow’s network of established, innovative and experienced strategic partners will provide advanced, high-quality US-based manufacturing solutions for small molecule active pharmaceutical ingredients (APIs) and raw materials. registered firsts (RSM) in all fields. development stages using state-of-the-art technologies and unique industry insights.

Phlow’s Continuous Care™ Consulting is an ideation model that provides differentiated pharmaceutical R&D services, including laboratory services, route finding and process scaling, laboratory proof of concept and cGMP Kilo and full-scale manufacturing services. In addition to existing facilities and capabilities, Phlow is completing the construction of highly automated manufacturing facilities and a bench-scale R&D laboratory that will be located adjacent to our partners, VCU’s Medicines for All Institute and United States Pharmacopeia (USP).

“We are excited to offer customized and advanced API and RSM research and development services to help other pharmaceutical and biotechnology companies in their development of medicines for Americans using flow chemistry and advanced manufacturing to catalyze a positive change,” said Eric Edwards, MD, Ph.D., co-founder, president and CEO of Phlow. “Together with our partners, Phlow’s goal is to provide valuable insights and industry-leading processes to other businesses to deliver high quality, improve yields, reduce costs, and preserve our environment in the world. ‘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 lead consultant. Dr. Malcom Berry is a world-renowned leader in the field of small molecule continuous processing, whose work includes the development of the world’s first multi-step continuous production platform, as well as laboratory technology and a flow of work for the development of continuous API processes. . In his new role, Dr. Berry will use his network and ongoing manufacturing expertise to enable peer-to-peer collaboration and the development of custom solutions.

“Phlow creates a unique and differentiated platform in the industry,” said Dr. Malcolm Berry, principal consultant at Phlow. “From personal experience, I know that continuous operation will enable real-time quality management and, through precise control of reaction parameters, will lead to reduced manufacturing deviations, which is great news for the patients.

VCU’s Medicines for All Institute and AMPAC Fine Chemicals have been working closely with Phlow since May 2020 under Phlow’s contract with the US 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 pharmaceuticals. AMPAC Fine Chemicals, a global leader and custom manufacturer of APIs, will provide advanced large-scale, commercial contract manufacturing services, including ongoing, to Phlow’s research and development customers.

“By expanding our current partnership with Phlow to serve the commercial sector, we are creating a unique ecosystem between industry and academia that brings together the best minds in advanced pharmaceutical development and manufacturing to solve a problem where there is an unmet need. satisfied,” said Frank Gupton, Ph.D., co-founder of Phlow, chair of the Department of Chemical Engineering and Life Sciences at Virginia Commonwealth University 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 United States”

“We are excited to continue working with Phlow, VCU’s Medicines for All Institute, and our other partners in pharmaceutical product development here in the United States,” 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 continue to build the Virginia Gateway region into an innovative, end-to-end, advanced manufacturing campus.”

Under an agreement announced in February 2021, USP, the leading independent, nonprofit science-based organization focused on building trust in the supply of safe, quality medicines, is building a new co-located laboratory with Phlow’s R&D labs and VCU’s Medicines for All Institute which will develop testing methods and standards for continuous manufacturing. This work will facilitate product development, technology transfer, and drug application filings using continuous manufacturing to drive wider adoption of continuous manufacturing by generic drug manufacturers and other pharmaceutical manufacturers. The expected impact of the alliance includes the development of first scientific guidelines for high quality continuous manufacturing processes.

“Continuous pharmaceutical manufacturing (CPM) has several advantages over traditional batch manufacturing, particularly during supply disruptions. These include the availability and use of real-time data to accelerate time to market. manufacturing scale and help improve the quality of medicines, enabling more efficient and agile production of essential medicines and strengthening the global supply chain,” said Ronald T. Piervincenzi, Ph.D., CEO “Furthermore, we hope that USP’s work with Phlow will help pave the way for the pharmaceutical industry to more broadly apply continuous manufacturing of the generic drugs that many patients rely on.”

Through a public-private partnership with the US government, Phlow has demonstrated proof-of-concept that its new continuous platform is revolutionizing small molecule API development. Specifically, Phlow provided critical medical API to the US government and successfully transferred several additional critical APIs to manufacturing for scaling. In 2021, Phlow became a member of the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) Contract Development and Manufacturing Organization Network. , created to provide national 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 excellence in contract execution. Phlow is proud to have been accepted into the FDA Emerging Technology Program for the development and continued manufacture of APIs.

Together, Phlow and the U.S. government are securing the country’s supply of essential medicines and medical countermeasures by leveraging continuous flows and advanced manufacturing technologies. Under this historic partnership, Phlow is building the infrastructure and performing R&D to create a resilient, U.S.-based, end-to-end essential medicines supply chain. Recognizing the importance of long-term sustainability and consistent with Phlow’s Business Sustainability Plan submitted as part of the US Government contract award, Phlow is committed to becoming self-sustaining and maximizing government investment. Providing innovative continuous manufacturing R&D services for the development of small molecule pharmaceuticals in the commercial sector is an important step towards realizing Phlow’s commitment.

About PhlowMT

Phlow Corp. is an innovative American essential medicines impact company that is reinventing the essential medicines supply chain by innovating the way these medicines are made. Founded in 2020, Phlow is committed to ensuring the nation has a predictable and stable national supply of essential medicines. Phlow is working to build a resilient end-to-end US-based, complete and fully integrated solution so that no patient goes to the hospital to find that the medication they need is not there. not available. With the support of an exceptional team, experienced strategic partners, and established relationships at the political, regulatory, and federal levels, Phlow will manufacture APIs and finished pharmaceuticals nationwide for essential medicines critical to the future of healthcare. . By 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. from environment to batch manufacturing. For more information, visit www.plow-usa.com.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220321005296/en/

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Grace Catlett
516-318-8563
gcatlett@rxmedyn.com