USP standards are relevant to large pharmaceutical and biopharmaceutical companies, emerging biotechnology firms, contract manufacturing organizations, and analytical services companies. They are utilized particularly by manufacturers whose products are marketed in or imported into the U.S. USP’s standards are used by companies, regulatory bodies, and other stakeholder groups in more than 140 countries worldwide. With its headquarters in Rockville, MD, USP also has sites and offices in Hyderabad, India; Shanghai, China; São Paulo, Brazil; and Basel, Switzerland.
USP–NF provides comprehensive information to guide quality at all stages of biological manufacturing—from raw material qualification to the development and validation of product assays to packaging. USP’s standards are critical to biopharmaceutical developers, QA/QC scientists, analytical development scientists, QbD specialists, regulatory experts on biologics, bioassay developers, and biostatisticians.
Collaborative partnerships between USP and other thought-leaders in the biologics area shape industry standards. Prospective partners are invited to submit monographs and proposals to revise and modernize standards relevant to biologics and biotechnology; supply candidate materials for USP Reference Standards development; participate in USP workshops and stakeholder forums that help inform the standards-setting process; and recommend ideas for future monographs, general chapters and Reference Standards.