USP is committed to collaborating with other scientific thought leaders to address current public health challenges and improve the quality of and access to medicines worldwide. We believe that together we can create a better future.
National Institute of Standards and Technology (NIST) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST), the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and USP have announced a research collaboration to assess analytical methods and develop standards for adeno-associated virus (AAV), an important mechanism for delivering gene therapies. Lean More
USP Shows Support for the Science and Technology Action Plan
USP signed on to the Science and Technology Action Plan that urges a renewed prioritization of science and technology research, and development and education in the U.S.
The Science and Technology Action Plan calls for the President’s Science Advisor to be elevated to the Cabinet (which has since been accomplished), a significant funding commitment to science and research over the next five years, and more effective federal coordination across research agencies. Importantly, the recommendations are compatible with and complementary to more specific advocacy for individual agencies and disciplines. You can read the full report and recommendations here.
The Science and Technology Action Plan was drafted by the Science and Technology Action Committee, a nonpartisan coalition of non-profit, academic, foundation, and corporate leaders working to reprioritize science and technology research, and development and education in the U.S.
In an environment where accelerated biopharmaceutical innovation is increasingly important, BioPhorum and USP are working together to harmonize industry practices and incorporate these into pharmacopeial standards to support the development, characterization, and manufacture of biopharmaceuticals.
BioPhorum and USP have signed a letter of intent that outlines how they will work together to facilitate joint scientific meetings and workshops to enhance awareness of challenges and best practices and engage scientific experts in discussions about advancing standardization. The two organizations are already working on topics of mutual interest, including trace metals, rapid methods, bioassays and plasmid DNA used in CGT manufacture.
- BioPhorum and USP collaborative journey to new standards
- Host cell protein (HCP): Benchmarking mass spectrometry standards for USP
- Webinar on Standards and Best Practices to Support Trace Metal Quantification in Cell Culture Chemically Defined Media and Hydrolysates
Phlow Corp., a public benefit essential medicines solutions provider, and USP announced a strategic alliance to develop a new laboratory that will certify and validate Pharmaceutical Continuous Manufacturing processes resulting in affordable, high-quality, U.S.-manufactured essential medicines. Throughout its 200-year history of setting standards for medicine quality, USP has been providing validated scientific methods used by manufacturers and regulators to determine what “good quality” looks like. The methods developed through this strategic alliance will be available for use by other domestic generics manufacturers to encourage broader adoption of Pharmaceutical Continuous Manufacturing in order to strengthen the U.S. drug supply.
USP extends collaborations with global pharmacopeias to strengthen quality standards, discuss known public health challenges, share expertise and participate in joint standard-setting and harmonization activities.
- BP and USP formalize collaboration to strengthen quality of medicines and public health
- USP and Chinese Pharmacopeia extend collaboration to improve medicines quality and patient safety
World Health Organization (WHO)
The World Health Organization (WHO) Executive Board has welcomed USP into official relations, recognizing USP as a trusted expert, advisor, and collaborator to ensure quality medicines around the world. Learn more
Dietary Supplements Quality Collaborative
The Dietary Supplements Quality Collaborative is a diverse group of national stakeholder organizations across the public health spectrum representing consumers, practitioners, manufacturing industry, research, standard-setting, and academic organizations committed to advancing the quality and safety of dietary supplements in the United States, ultimately helping protect the public’s health. Learn more
Asia-Pacific Economic Cooperation (APEC)
USP is supporting the Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF), a government and industry platform for 21 economies around the Pacific, to disseminate best practices, standards, and guidance that improve the quality and security of global pharmaceutical supply chains. Learn more
Food Safety and Standards Authority of India (FSSAI)
USP and the Food Safety and Standards Authority of India (FSSAI) have been collaborating to strengthen quality standards and regulations to help improve access to quality food and dietary supplements for people in India. The activities proposed under their Memorandum of Understanding include training programs on the standards-setting process and scientific exchange programs. Learn more
International Pharmaceutical Excipients Council of India
USP India is an active member of International Pharmaceutical Excipients Council of India and participates in their initiative to review standards published by various pharmacopeias to strengthen the quality of excipients manufactured worldwide and protect public health to support USP’s mission.