USP Biologics

From raw material qualification, to the development and validation of product assays, to packaging, USP supports industry innovation of biologics and biotechnology. With a growing line of documentary and reference standards for all phases of product development and manufacturing cycles, our portfolio includes--or is expanding to address--standards for glycan analysis, bioassays, enzymes, proteins, peptides, amino acids, blood and plasma-derived products, ancillary/process materials, endotoxins, monoclonal antibodies, cell and tissue therapy, and excipients.
USP also hosts workshops and USP Education courses on timely bio-focused topics, and offers opportunities for industry involvement in its standards-setting process.


What's New


In this Section:

Documentary Standards

Reference Standards

USP Expertise

Biologics Meetings & Courses

Resources & Tools