Phlow Corp. and USP Form Alliance

Phlow Corp., a public benefit essential medicines solutions provider, and the United States Pharmacopeia (USP) announced a strategic alliance to develop a new laboratory that will certify and validate Pharmaceutical Continuous Manufacturing processes resulting in affordable, high-quality, U.S.-manufactured essential medicines. Throughout its 200-year history of setting standards for medicine quality, USP has been providing validated scientific methods used by manufacturers and regulators to determine what “good quality” looks like. The methods developed through this strategic alliance will be available for use by other domestic generics manufacturers to encourage broader adoption of Pharmaceutical Continuous Manufacturing in order to strengthen the U.S. drug supply.

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 U.S. FDA. The alliance will facilitate Phlow’s application of “flow” chemistry and other continuous advanced manufacturing processes to produce the crucial ingredients that enable domestic, end-to-end drug manufacturing of essential medicines that have been or are at risk of being in shortage thereby contributing to a more resilient medicines supply chain.

“Phlow has embarked on a bold mission to provide access to affordable, high-quality essential medicines for every American,” said Eric Edwards, M.D., Ph.D., co-founder, president and CEO of Phlow. “We are fixing the broken essential medicines supply chain by creating a solution that is 100% U.S.-based and fully integrated. Our success, which is made possible by partners like USP, is achieved only when every human being has access to the most important medicines necessary to sustain life and conquer disease.”

“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.”

As part of the alliance, USP scientists will be employed at a new laboratory facility operated by USP that will be developed onsite at the Virginia Biotechnology Research Park, which includes Virginia Commonwealth University’s Medicines for All Institute. 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 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.”

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.

“Through this partnership with USP, the leading independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, Phlow will help assure the essential medicines being developed and manufactured meet the highest quality standards. We hope the USP and Phlow program will serve as a catalyst for industry change as we work together to apply pioneering flow chemistry, advanced manufacturing and novel analytical approaches to these critical medicines,” said Edwards. “We believe the essential medicines we make at Phlow today, in partnership with USP, will save countless American lives tomorrow.”