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.
USP Biologics standards are organized by product classes. Each page below includes the latest updates related to reference standards and documentary standards for a specific product class.
two-blue-white
Biologics 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:
Roundtables:
two-blue-white
Development and Characterization of Biologics
Quality standards have long been part of the testing process used to help ensure the identity, purity and potency of drugs. But the requirements and challenges for biologics quality standards from standards for small molecule APIs. Learn about the evolution of quality standards and how USP is working with manufacturers and regulatory agencies to develop solutions for biopharmaceutical manufacturing quality challenges.
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.
Stay informed
Check out our new blog, newsletter and other resources that can help you stay informed and ensure the quality of biologics and peptides.
Get updates in your inbox
Subscribe to USP’s Biologics newsletter to stay up to date with the latest information about biologics standards and access valuable resources, such as guidelines, webinars and more.