USP opens Advanced Technologies Laboratory to drive pharma manufacturing innovations
Independent scientific organization U.S. Pharmacopeia (USP) has announced the opening of its Advanced Technologies Laboratory in Rockville, Maryland to develop, pilot, and scale innovations in pharmaceutical manufacturing.
The goal of USP’s lab is 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),” according to the announcement.
Among other initiatives, the lab will support the development of alternative and novel synthetic methods to produce active pharmaceutical ingredients (APIs) and key starting materials, as well as assist industry and regulators to accelerate the adoption of new technologies that help to mitigate supply chain risks.
In April, USP released an analysis showing that more than half of the APIs for prescription medicines in the U.S. come from India and the European Union (EU). The report found that just 12% of total API volume is made in the U.S., excluding IV fluids such as saline. USP noted that the “major hubs” of production are India and the EU, with European countries like Norway and Switzerland cited as important contributors.
Generic drugs, which make up 90% of prescription volume in the U.S., come primarily from India — while 43% of branded pharmaceutical API comes from the EU, according to USP.
Ronald Piervincenzi, CEO of USP, in a statement in Wednesday’s announcement about the opening of its lab noted that advanced manufacturing technologies “make possible the responsive, distributed manufacturing and onshoring strategies that make our medicine supply chains more secure and reliable” while the “adoption at commercial scale can be challenging, especially for generic manufacturers.”
Currently, USP operates more than 70,000 square feet of laboratory space at sites in the U.S. and India, providing expertise in developing quality and process standards, establishing and validating analytical methods, as well as characterizing impurities and synthesizing organic compounds.
The Advanced Technologies Lab in Maryland is USP’s latest investment in advanced manufacturing technologies, with plans to continue expansion with the addition of an 8,000-square-foot laboratory in 2026.
Emily Kaine, senior vice president of global health and manufacturing services at USP, said in a statement that its “unique capabilities and decades of expertise can help overcome the barriers that have limited the adoption of advanced manufacturing technologies” resulting in more efficient and expanded production of critical medicines and more secure and reliable supply chains.