Safeguarding the quality of medication is fundamental to protecting the public's health, especially as ingredients and products come from all over the world. Biologics — such as recombinant therapeutic proteins, vaccines, blood components, tissues and gene therapies — are growing faster than any other segment of medicine. Just as they do for chemical medicines, manufacturers must ensure the purity and quality of the biologics that make their way to patients. USP quality standards serve as the foundation for a robust safety network that assists manufacturers by increasing predictability and reliability, and preserving the integrity of the global supply chain.
Protein standards
Peptide standards
Blood-related standards
Cell, gene and tissue standards
Glycosaminoglycans and carbohydrates standards
Raw and ancillary materials standards
Vaccine standards
Education and training resources
Events and summaries
Events & Training
Courses:
- USP General Chapters and Reference Standards that Support the Development and Characterization of Biologics - On Demand Webinar
View all USP education courses
Events:
- USP’s Global Biologics Summit: Virtual Edition-Executive Summary
- Gene Therapy CMS Workshop Executive Summary
- Analytical Methods to Support Vaccine Quality
Roundtables:
- USP virtual roundtable on insulin quality: Executive summary
- Roundtable on precision medicine and genomics
- USP Biologics stakeholder forum: Executive summary
- Roundtable on mRNA standardization
- Roundtable on visible particles
- Roundtable on performance standards development for chromatographic column qualifications
Our commitment to quality begins with our process
Our goal is to create broadly applicable standards that benefit both the industry and public health. Every decision we make—including the decision to move ahead with a proposed standard—is made with that intent in mind.
Call for participation in a laboratory study on the analysis of monoclonal antibodies USP will be releasing three new monoclonal antibody standards soon and is planning a round robin study to expand upon the collaborative testing of these materials to include additional laboratories and analytical methods. The study will include tests from USP Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies (e.g. SEC-HPLC, CE-SDS, oligosaccharides) as well as non-compendial tests (e.g. cIEF/icIEF, MS-based glycan, MW by MS). The opportunity to evaluate the new standards using in-house assays will also be available. If your laboratory is interested in participating in all or part of this study, please contact USP at USPBiologics@USP.org. Deadline is September 30th.
Standards development process
We are committed to ensuring that our approach evolves with the science of biologics and the needs of stakeholders, including patients, practitioners, industry and regulators.
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