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 now!

  • Upcoming Workshops and Pharmacopeial Education Courses:
    • 3rd USP Peptides Workshop: Synthetic Therapeutic Peptides: Regulations, Standards and Quality, November 14-15, 2016, in Rockville, MD. N-linked Glycan Analysis: New Compendial Procedures and Associated Reference Standards (Free Webinar), October 6, 2016, 11 a.m. – 12 p.m. EST
    • N-linked Glycan Analysis: New Compendial Procedures and Associated Reference Standards (half-day course), October, 2016, China
    • CPC and USP Global Peptide Symposium, October 19-21 in Hangzhou, China
  • Updated Expert Committee Workplans

 



In this Section:

Documentary Standards

Reference Standards
 

USP Expertise
 

Biologics Meetings & Courses
 

Resources & Tools