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, 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 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.
- New Reference Standards: Cosyntropin Acetate [NEW], Insulin Lispro, Dextran 70 System Suitability, Heparin Sodium Identification, Heparin Sodium Molecular Weight Calibrant, and more…
- Newly Proposed Standards Published in PF 40 (6): <503.1> Trifluoroacetic Acid (TFA) in Peptides [NEW], <503> Acetic Acid in Peptides, and more…
- Workshop Report: Synthetic Therapeutic Peptides—Regulations, Standards and Quality, October 1, 2014