Phlow-United States Pharmacopeia Plan Richmond, Virginia, Joint Medical Research Venture
The new USP laboratory will be co-located with the R&D Laboratories at Phlow and the Virginia Commonwealth University’s Medicines for All Institute to support analytical process development and testing designed to improve efficiency in cost and time to produce essential medicines. Laboratory facilities and instruments in USP's Rockville laboratory will also be used to expand capabilities and capacity for other analytical and testing projects.
“Phlow’s partnership with the USP, working alongside the Virginia Commonwealth University’s Medicines for All team represents another key resource in our efforts to strengthen our supply chain for essential medicines,” said Frank Gupton, Ph.D., co-founder of Phlow, chair of Virginia Commonwealth University's (VCU) Department of Chemical and Life Science Engineering and CEO of the Medicines for All Institute. “USP is the recognized leader in quality standards for pharmaceuticals and their commitment to this effort underscores the importance that we all place on delivering medicines that are of the highest quality. We look forward to our collaboration with USP and Phlow in this important initiative to secure onshore manufacturing in the U.S.”
Phlow currently leverages the advanced manufacturing processes developed by Virginia Commonwealth University’s Medicines for All Institute to produce active pharmaceutical ingredients for essential medicines that are in short supply.
The anticipated impact of the partnership includes the development of early scientific and regulatory guidelines for high-quality continuous manufacturing processes. The partnership will also create a foundation for successful product development, tech transfer, and drug application filings and will guide the post tech transfer verification of active pharmaceutical ingredients, intermediates, and dosage forms. As a result, the partnership will provide validation of U.S.-based advanced manufacturing processes to increase local production capacity and reduce the over-dependance on exports from just a few countries.
“When crises such as natural disasters, geopolitical strife including barriers to trade and pandemics like COVID-19 arise, major interruptions in the global supply of quality medicines have an impact on American patients,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “Pharmaceutical Continuous Manufacturing 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. 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.”
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