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 General Chapters and Reference Standards that Support the Development and Characterization of Biologics - On Demand Webinar
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.