USP & Biologics & Biotechnology Manufacturers
USP supports the innovation of the global biologics and biotechnology industry with a growing line of documentary and reference standards for all phases of product development and manufacturing cycles—from raw material qualification to the development and validation of product assays, to packaging. Our portfolio includes or is expanding to address standards for glycan analysis, bioassays, 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 Global Education and Training courses focused on timely bio-focused topics, and offers unique opportunities for industry involvement in its standards-setting process. Visit the links below to learn more about our work and how it can benefit yours.
- 2013 USP Workshop Series: Cell and Tissue-based Regenerative Medicine Products: From Characterization to Compendial Assays (Co-sponsored by ISCT and USP), November 7–8, 2013
- New Reference Standards: Acarbose, Acarbose System Suitability Mixture, Hemoglobin Protease Substrate
- Newly Proposed Standards Published in September PF: Fondaparinux Sodium, Fondaparinux Sodium Injection, Prekallikrein Activator <165>, Somatropin Bioidentity Tests <126> and more
- 2014 Workshop: 6th Bioassay Workshop, June 2–3, 2014