The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.
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The US Pharmacopeia (USP) announced on June 4, 2025 that it has opened its Advanced Technologies Laboratory in Rockville, Md. The lab and related expertise will be utilized to develop and scale innovations to create efficient and expanded drug production that the organization believes will help secure supply chains. The lab builds onto USP’s 70,000 square feet of laboratory space located across the United States and India. The organization plans an additional 8000 square feet of lab space in 2026.
The lab will allow USP to assist manufacturers in the adoption of advanced manufacturing technologies by developing approaches and processes for flow chemistry as well as the use of advanced analytical techniques (e.g., process analytical technology) to enable real-time quality monitoring. The development of alternative and novel synthetic routes for API production will also be supported with key starting materials. “Taken together, these capabilities are essential in efforts to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine,” USP stated in a press release (1).
“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, PhD, chief executive officer of USP, in the release. “The Advanced Technologies Lab will help launch and scale innovations that get products to patients more efficiently, while strengthening our medicine supply chains.”
USP’s end-to-end supply chain analytics and solutions include chemical precursors for finished drug products and comprehensive mapping of the supply chain to identify safety risks. The new lab will assist in the adoption of new technologies to mitigate these supply chain risks and establish guidance to support regulatory actions and create efficiencies to strengthen domestic drug manufacturing.
The supply chain of APIs, other materials, and finished drug products is an ongoing concern for both manufacturers and regulators. Risks to the supply chain include poor API quality, which can result in interruptions in production (2). “Because of the poor-quality API, additional quality control measures become necessary, driving up costs and diminishing profit margins. If such issues arise repeatedly, they can harm a company’s reputation and undermine market confidence in its products. Beyond these commercial setbacks, manufacturers also face considerable legal and regulatory risks if they fail to meet the standards required for pharmaceutical quality and patient safety,” Qixuan Lu, vice-president of Process Chemistry at BioDuro, said in an interview with Pharmaceutical Technology® (2).
In Europe, the European Commission has proposed the Critical Medicines Act to improve drug production and secure the drug supply chain in Europe. The Act addresses problems associated with manufacturing capacity, diversification, dependencies on foreign materials, and market demand (3).
“The Advanced Technologies Lab exemplifies USP’s commitment to advancing efficient, quality, and sustainable pharmaceutical manufacturing through the application of cutting-edge technologies,” said Emily Kaine, SVP of Global Health and Manufacturing Services, in the USP press release (1). “USP’s unique capabilities and decades of expertise can help overcome the barriers that have limited the adoption of advanced manufacturing technologies. Doing so will help ensure that the medicines people rely on for health are available when and where they’re needed.”
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