USP Biologics™

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.

ATCC and USP Launch First Set of Products to Advance Quality and Reduce Risk in the Development of Biological Therapeutics and Vaccines

Six new products that can be used to detect residual host cell genomic DNA (gDNA)

Learn more

PLBL2 HCP Analytical Reference Material is now available

Identification and quantitation of PLBL2 HCP during mAb manufacturing

Learn more

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

Explore the guide