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.
Biologics
How Do You Manufacture
High Quality Peptides?
Join us for the 5th USP Workshop on
Therapeutic Peptides Regulations, Standards
and Quality.
The Need for Speed in
Cell and Gene Therapies
See why rapid microbial methods are needed
for cell therapy, tissue-engineered and gene
therapy products.
Biologics Product Classes
As biopharmaceuticals continue to evolve, USP
is keeping pace with quality standards in multiple
biologics categories.
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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
Workshops:
- 5th USP Workshop on Therapeutic Peptides: Regulations, Standards and Quality
November 5, 2018 | November 6, 2018
Events:
- CHI Bioprocessing Summit
August 13-17, 2018 - The 2nd Annual Biologics Formulation and Analysis Summit
September 20, 2018 - PPTD 2018
October 10, 2018
Roundtables:
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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.