Biologics

From raw material qualification, to the development and validation of product assays, to packaging, USP supports industry innovation of biologics and biotechnology. With a growing line of documentary and reference standards for all phases of product development and manufacturing cycles, 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 USP Education courses on timely bio-focused topics, and offers opportunities for industry involvement in its standards-setting process.

 

What's New

General Chapters that Support Development and Characterization of Biologics (Download free!):

Also Featured! USP General Chapter <124>  Erythropoietin Bioassays (official in USP 39)

Did you miss our previously featured chapters? Download <89.1> Collagenase I, <89.2> Collagenase II<212> Oligosaccharide Analysis<127> Flow Cytometric Enumeration of CD34+ Cells<129> Analytical Procedures for Recombinant Monoclonal Antibodies

  • New Biologics Reference Standards: 
    • Erythropoietin (released soon!)
    • PS NMR System Suitability (released soon!)
    • Prekallikrein Activator
    • Collagenase I
    • Collagenase II
    • CD 34+ Cell Enumeration System Suitability
    • Exenatide
    • [Glu13]-Exenatide
    • [Met(O)14]-Exenatide
    • [N-Acetyl1-His1]-Exenatide
    • Calcitonin Salmon Related Compound A
    • Corticotropin
  • Newly Proposed Standards Published in PF 43(3):
    • Desmopressin Acetate
    • Triptorelin Pamoate (NEW)