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

Featured Biologics General Chapters:

Did you miss our previously featured chapters?  Download <212> Oligosaccharide Analysis, <507> Protein Determination Procedures, <129> Analytical Procedures for Recombinant Monoclonal Antibodies

  • New Biologics Reference Standards:
    • [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)