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.
Resources
mAb Analytical Guide
Analytical assays and methods created throughout clinical development are important in any regulatory filing. Monoclonal antibodies (mAbs) are no exception. Thorough and reproducible analytical methods can accelerate product and process development, which can lead to earlier submissions for regulatory approval, and subsequent product launches.
USP has developed a free interactive tool, in collaboration with scientific and regulatory experts, to provide easy-access to mAb related-resources such as:
- Relevant documentary standards found in the USP-NF compendium recognized by the FDA and many regulatory bodies around the world
- Peer-reviewed publications, conference presentations, posters, and technical notes
- Physical reference standards
- USP education courses
Events & Training
View all education courses and events
Recent Roundtable Summaries
- USP Virtual Roundtable on AAV
- USP virtual Roundtable on Continuous Manufacturing in Biologics: Executive Summary
- USP virtual roundtable on insulin quality: Executive summary
- Roundtable on precision medicine and genomics