Phlow, USP to establish continuous manufacturing validation lab

By The Science Advisory Board staff writers

February 23, 2021 -- Phlow and United States Pharmacopeia (USP) have formed a strategic alliance to develop a new laboratory to certify and validate continuous pharmaceutical manufacturing processes.

USP is a nonprofit organization that develops public standards to establish quality expectations for medicines. The alliance will facilitate Phlow's integration of flow chemistry and other advanced manufacturing processes to produce critical ingredients that enable end-to-end drug manufacturing of essential medicines that have been or are at risk of being in shortage, thus strengthening the U.S. medicines supply chain.

Through the alliance, USP scientists will operate at a new laboratory facility onsite at the Virginia Biotechnology Research Park in Richmond. The new lab will be co-located with research and development labs at Phlow and the Virginia Commonwealth University Medicines for All Institute to support analytical process development and testing to improve efficiency in cost and time to produce medicines. Lab facilities and instruments in UPS's Rockville, MD, lab will also be used to expand capabilities and capacity for other analytical and testing projects.

The anticipated project outcomes include development of early scientific and regulatory guidelines for high-quality and continuous manufacturing processes. The partnership will also create a foundation for successful product development, technology transfer, and drug application filings and will guide the post technology transfer verification of active pharmaceutical ingredients, intermediates, and dosage forms.

The methods developed through the alliance will be made available to other domestic generic manufacturers to encourage broader adoption of continuous manufacturing techniques in the U.S.

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