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 Pharmacopeial Education 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.
- Proposed Revisions to the General Notices and Requirements Published for Comment in Pharmacopeial Forum 39 (1)
- 2013 USP Workshop Series: Measurement of Residual Host Cell Protein and DNA in Biotechnology Products on June 3–4
- New Reference Standards: Filgrastim, Heparin Sodium Molecular Weight Calibrant, Insulin Aspart
- Newly Proposed Standards Publish in March PF: Cosyntropin, Particular Matter, Cryopreservation and more
- Newly Proposed Standards Publish in May PF: Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies and more