USP, Phlow say new labs will bolster continuous manufacturing

Regulatory NewsRegulatory News | 13 December 2022 |  By 

Ronald Piervincenzi (left), Caren Merrick (center), Eric Edwards (right)

Updated 14 December 2022 to clarify Phlow's funding sources*

RICHMOND, VA – The United States Pharmacopeia (USP) and Phlow Corporation on Monday opened new laboratories at the Advanced Pharmaceutical Development Center that the pair say could spur the uptake of continuous manufacturing in the pharmaceutical industry.
Officials at the labs’ unveiling promoted the ability of continuous manufacturing to increase drug quality and improve the resilience of the drug supply chain alongside Virginia Secretary of Commerce and Trade Caren Merrick.
The alliance will expedite Phlow’s application of continuous manufacturing to produce essential drugs that are in shortage, while USP’s role is to test the final products produced from this mode of manufacturing, said a joint announcement.
This partnership is designed to reduce the barriers for companies to develop continuous manufacturing methods and to reduce US reliance on other countries for essential drugs, explained USP CEO Ronald Piervincenzi at the opening.
“The barriers to advanced manufacturing are common to those of any new technologies for regulated industries. What we see is the reluctance to take the risk and the worry that regulators won’t approve it, yet despite all of this, the need is clear not only to be able to product a quality medicine but to do it reproducibly and at small scale. This is critical for medicines that are in short supply,” he said.
Phlow CEO Eric Edwards said the company’s mission is to “create a reliable supply of high-quality medicines through advanced manufacturing” and that the firm partners with other organizations to achieve this goal. The company has partnered with Virginia Commonwealth University’s (VCU) Alliance for Medicines For All Institute in providing essential medicines for at risk of shortage.
Edwards said that Phlow’s partnership with USP complements its mission to support the use of advanced manufacturing techniques and to reduce reliance on other countries for providing needed medicines.
The labs will focus on developing drug assays, including stability indicating tests; methods to control impurities; cleaning validation; purity analysis; material isolation, identification and characterization; and spectrometric and other process analytical technology applications.
Piervincenzi told Focus that USP decided to “get in front” of advanced manufacturing and “not wait for industry to innovate on this,” as industry is not familiar with measuring drug quality produced in a continuous manufacturing line.
“This is like the chicken and the egg, but we decided we will be the chicken, so we would build this” capability, he said. Eventually pharmaceutical companies will have the expertise to build this analytical capability on their own without USP’s involvement.
Piervincenzi added that “while continuous manufacturing is not anything hard, it is substantially different. You can still do a test of the final product, for sure, but that is not sufficient to test on your final product.”
Despite the International Council for Harmonisation’s (ICH) adoption of its Q13 guideline on continuous manufacturing earlier this month, widespread application of the technique has been slow. (RELATED: ICH adopts Q13 guideline on continuous manufacturing, Regulatory Focus 5 December 2022)
The labs are jointly funded by USP and Phlow. USP derives its funding from the sale of reference standards and other government and private sources, while Phlow contributed funds raised from a Series A preferred offering round in 2021. Phlow has also received separate funding from the federal Biomedical Advanced Research and Development Authority (BARDA) to develop COVID-19 drugs and other drugs that are in shortage.
USP/Phlow announcement

*A previous version of this story mistated Phlow's funding source for the new laboratory. Regulatory Focus regrets the error.


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