The U.S. Pharmacopeia (USP) has opened its Advanced Technologies Laboratory in Rockville, Maryland. USP will use this lab to develop, pilot, and scale innovations that foster more efficient and expanded production of quality medicines for stronger and more secure supply chains.

The lab expands USP capabilities to help manufacturers overcome barriers in the adoption of advanced manufacturing technologies by developing new approaches and processes for flow chemistry and additive manufacturing coupled with advanced analytical techniques such as process analytical technologies (PAT) that can enable real-time quality monitoring. The lab will also support the development of alternative and novel synthetic routes to produce active pharmaceutical ingredients (APIs) and key starting materials. Taken together, these capabilities are essential in efforts to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine.

“Advanced manufacturing technologies make possible the responsive, distributed manufacturing and onshoring strategies that make our medicine supply chains more secure and reliable. But adoption at commercial scale can be challenging, especially for generic manufacturers,” said Ronald T. Piervincenzi, Ph.D., Chief Executive Officer of USP. “The Advanced Technologies Lab will help launch and scale innovations that get products to patients more efficiently, while strengthening our medicine supply chains.”

The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.

The Advanced Technologies Lab is the latest of USP’s investments in advanced manufacturing technologies. USP plans to continue expanding its advanced technology footprint into an additional 8,000 square foot laboratory in 2026.