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, 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.
- Synthetic Therapeutic Peptides – Regulations, Standards and Quality, October 1, 2014
- New Reference Standards: Fetal Bovine Serum, Fondaparinux Sodium family of RS’s, Dalteparin Sodium, Insulin Glargine for Peak Identification, and more…
- Newly Proposed Standards Published in July PF 40 (4): Gonadorelin Hydrochloride , <1132>Residual Host Cell Protein Measurement in Biopharmaceuticals, and more