The US Pharmacopeia (USP) announced the opening of its Advanced Technologies Laboratory in Rockville, Maryland, marking a significant expansion of the organization's capabilities to address pharmaceutical supply chain vulnerabilities and manufacturing challenges. The facility, which opened on June 4, 2025, represents USP's strategic investment in developing solutions for more efficient and secure drug production.
Expanding Manufacturing Innovation Capabilities
The new laboratory builds upon USP's existing 70,000 square feet of laboratory space located across the United States and India, with plans for an additional 8,000 square feet of lab space in 2026. The facility will focus on developing approaches and processes for flow chemistry and advanced analytical techniques, including process analytical technology, to enable real-time quality monitoring during drug manufacturing.
"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. "The Advanced Technologies Lab will help launch and scale innovations that get products to patients more efficiently, while strengthening our medicine supply chains."
Addressing Critical Supply Chain Risks
The laboratory's development comes in response to ongoing concerns about API quality and supply chain disruptions. According to industry experts, poor API quality can result in production interruptions and increased costs. "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," explained Qixuan Lu, vice-president of Process Chemistry at BioDuro.
The facility will support the development of alternative and novel synthetic routes for API production with key starting materials. These capabilities are designed to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine applications.
Comprehensive Supply Chain Solutions
USP's end-to-end supply chain analytics and solutions encompass chemical precursors for finished drug products and comprehensive mapping of the supply chain to identify safety risks. The new laboratory will assist manufacturers in adopting new technologies to mitigate these supply chain risks and establish guidance to support regulatory actions while creating efficiencies to strengthen domestic drug manufacturing.
"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. "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."
Global Context and Regulatory Alignment
The initiative aligns with broader international efforts to secure pharmaceutical supply chains. In Europe, the European Commission has proposed the Critical Medicines Act to improve drug production and secure the drug supply chain, addressing problems associated with manufacturing capacity, diversification, dependencies on foreign materials, and market demand.
The Advanced Technologies Laboratory represents USP's commitment to fostering broader implementation of cutting-edge manufacturing techniques while addressing quality assurance challenges. The facility will serve as a hub for research, collaboration, and testing of state-of-the-art processes designed to streamline pharmaceutical production and ensure consistent access to high-quality medicines.
