Phlow Corp. and U.S. Pharmacopeia Announce the Opening of Laboratories at the Advanced Pharmaceutical Development Center in Richmond, Virginia
Richmond, VA., – Phlow Corp., a U.S.-based public benefit corporation and contract development and manufacturing organization (CDMO), and the U.S. Pharmacopeia (USP), announced the opening of laboratories co-located at the Advanced Pharmaceutical Development Center at Virginia Biotechnology Research Park in Richmond, Virginia. Phlow and USP’s laboratories, located adjacent to Virginia Commonwealth University’s Medicines for All Institute, will provide pharmaceutical and biotechnology companies, as well as the U.S. Government, with best-in-class R&D services for small molecule active pharmaceutical ingredients (APIs) and key starting materials (KSMs) that leverage advanced manufacturing technologies to help with the development of affordable, high-quality, life-changing medicines.
USP, a global, scientific not-for-profit organization located in Rockville, Maryland, develops public standards that establish the quality expectations for medicines, collaborating with scientific experts from the academic, industry, and healthcare practitioner communities along with the United States Food and Drug Administration. USP will leverage its new laboratory capacity to develop analytical methods to help ensure the quality of medicines made with advanced manufacturing technologies like pharmaceutical continuous manufacturing. This capacity includes traditional off-line analytical testing and advanced in-line and at-line methods such as process analytical technologies.
“Reducing technical and training barriers to adoption of advanced manufacturing technologies like pharmaceutical continuous manufacturing will help strengthen resilience by allowing medicines to be made in more places. This diversifies sources of supply and strengthens the medicines supply chain,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “Our new analytical laboratory service offerings extend USP’s capability to assist manufacturers considering the adoption of continuous manufacturing, and will help ensure availability of trusted, quality medicines made with continuous manufacturing alongside those made with traditional batch manufacturing technology.”
The USP and Phlow collaboration will facilitate the development of guidelines, best practices and resources to assist in the adoption of advanced manufacturing technologies. Leveraging in- house scientific expertise and state-of-the-art facilities, USP and Phlow will offer R&D analytical solutions that include – though are not limited to – drug assays, methods to control impurities, cleaning validation, purity analysis, material isolation, identification and characterization, spectrometric and other process analytical technology applications, and more.
“Our contract development and manufacturing organization is on a mission to offer a range of customized services for small molecule APIs and KSMs to help pharmaceutical and biotech companies of all sizes reduce production costs, decrease development time, and lower their environmental impact by serving as an extension of each customer’s R&D team,” said Eric Edwards, M.D., Ph.D., co-founder, president, and CEO of Phlow. “Phlow is uniquely positioned to further expand its impact by now delivering differentiated R&D services at our new laboratory as part of our essential work to help develop and scale pharmaceutical products in the United States more cost effectively while improving time to market.”
“Phlow and USP will work side-by-side at the Advanced Pharmaceutical Development Center in a way that complements each other’s efforts to support the use of advanced manufacturing technologies. Ultimately, the two labs will work to qualify best-in-class, U.S.-based advanced manufacturing processes that can help increase geographic diversity in manufacturing capacity and reduce over-reliance on medicines from just a few countries,” said Andrew Carpenter, Ph.D., Executive Vice President of Manufacturing, Science, and Technology at Phlow.
In addition to its new R&D lab, Phlow is also in the process of further growing its advanced manufacturing infrastructure and capabilities as part of its mission to domestically manufacture life-changing medicines. Phlow is on track to open cGMP API manufacturing facilities in Petersburg, VA in 2023 and 2024 to move programs into an advanced manufacturing environment. The facilities will provide a platform for accelerating the transfer of processes developed in the lab into medium and large-scale reactors to support early-to-late stage clinical and commercial production.
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