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.
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.
Get customer support at every step to enable your success
You'll have the support of our science experts, education team, informational resources and global customer support.
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.