ROCKVILLE, Md. — The U.S. Pharmacopeia (USP) announced the opening of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia as part of its launch of a suite of R&D analytical solutions. These analytical lab services will support the efforts of drug manufacturers seeking to adopt advanced manufacturing technologies including pharmaceutical continuous manufacturing (PCM) as one way to help increase geographic diversity in pharmaceutical manufacturing and support medicines supply chain resilience.

“While presenting potential advantages, adopting new technologies comes with challenges. When it comes to PCM, not all companies have access to the expertise, resources, or capacity to develop and qualify new in-line, at-line, and off-line analytical methods required for the new manufacturing processes,” said Dennis Hall, USP Vice President, Advanced Manufacturing Technologies. “USP’s analytical lab service offerings can help fill the gap, and assist manufacturers to further drive innovation, contain production costs, and optimize efficiencies in staffing and resources while facilitating market access to quality medicines made with PCM. Our facility in Richmond provides capacity to support these vital services.”

Reducing technical and training barriers to adoption of advanced manufacturing technologies like PCM will help strengthen resilience by allowing medicines to be made in more places. This diversifies sources of supply and strengthens the medicines supply chain,” said Ronald Piervincenzi, Ph.D., CEO of USP. “Our new analytical laboratory service offerings extend USP’s capability to assist manufacturers considering the adoption of PCM, and will help ensure availability of trusted, quality medicines made with PCM alongside those made with traditional batch manufacturing technology.”

The new R&D analytical solutions will consist of analytical lab services that leverage USP’s in-house scientific expertise and state-of-the-art facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as USP’s headquarters facility in Rockville, Maryland. These capabilities will be used to characterize materials, and develop and qualify methods to help ensure the quality of medicines made with PCM. Areas of focus will include (but not be limited to):

• Drug assays, including stability-indicating tests
• Methods to control impurities (including mutagenic, process, and unknown impurities, as well as residual solvents)
• Cleaning validation
• Purity analysis
• Material isolation, identification, and characterization
• Spectrometric and other process analytical technology applications