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

Nature Biotechnology Article (free download through February 22, 2017!)
The US Regulatory and Pharmacopeia Response to the Global Heparin Contamination Crisis

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:
    • Exenatide
    • [Met(O)14]-Exenatide
    • [N-Acetyl-His1]-Exenatide
    • [Glu13]-Exenatide
    • CD34+ Cells
    • Collagenase I
    • Collagenase II
    • Prekallikrein Activator 
    • And more
  • Newly Proposed Standards Published in PF 42 (5):
    • <503> Acetic Acid in Peptides
    • <503.1> Trifluoroacetic Acid (TFA) in Peptides
    • <509> Residual DNA Testing, Fondaparinux (and Injection)
    • Insulin Aspart, Teriparatide (and Injection)