Phlow and US Pharmacopeia open labs for API R&D services

By Ben Hargreaves

- Last updated on GMT

© chemicalbilly / Getty Images
© chemicalbilly / Getty Images

Related tags Usp Drug API

The partners announce that their lab facilities have opened, equipped with advanced manufacturing technologies to create API and KSMs.

Phlow Corp. and US Pharmacopeia (USP) opened the laboratories at the Advanced Pharmaceutical Development Center at Virginia Biotechnology Research Park in Richmond, US.

The two partners’ labs are ‘co-located’ to allow them to collaborate on guidelines, best practices and resources to assist the adoption of advanced manufacturing techniques.

The organizations will use the laboratories themselves to provide R&D services to the pharma industry and the US government for the production of small molecule active pharmaceutical ingredients (APIs) and key starting materials (KSMs).

According to the partners, they will leverage advanced manufacturing technologies to produce high quality and affordable medicine.

USP is a not-for-profit organization that works to establish quality expectations for medicines, in collaboration with the scientific community. The organization will use its laboratory space in Virginia to develop analytical methods to help ensure the quality of medicine produced through advanced manufacturing techniques, such as continuous manufacturing.

The lab’s capacity will include traditional off-line analytical testing, as well as advanced in-line and at-line methods, such as process analytical technologies.

For Phlow’s part, it will use its lab to provide customized services for small molecule APIs and KSMs, particularly with the aim of reducing production costs, decreasing development time, and lowering the environmental impact of processes.

The partnership between the two organizations was revealed last year​, with the aim of using advanced manufacturing techniques to facilitate the domestic production of crucial ingredients for essential medicines. The overall goal of the project is to create a more resilient supply chain for essential medicines in the US.

Eric Edwards, CEO of Phlow, previously told Outsourcing-Pharma​ why there was a need for such work: For essential medicines, it has not been cost-effective for generic companies to manufacture in the US, thus, offshoring API production with foreign suppliers has been a common business practice over the last few decades. There is a very limited domestic capacity to make these essential medicine ingredients; the US manufacturing base to make them has drastically eroded over the last several decades, and most of the supply now comes from abroad.”

In terms of what the partners will offer to interested parties, the organizations stated that they will be able to provide R&D analytical solutions that include: drug assays, methods to control impurities, cleaning validation, purity analysis, material isolation, identification and characterization, spectrometric and other process analytical technology applications, and more.

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