USP Expertise

The development and revision of USP’s biologic and biotechnology standards is undertaken and guided by volunteer experts serving on USP Expert Committees and USP Expert Panels. The work of these volunteers is supported by USP’s scientific staff and state-of-the-art biologic laboratory facilities.

Expert Committees & Expert Panels

USP standards are in a process of continuous review and revision based upon new evidence, emerging public health concerns, and requests for revision from FDA, the public, and other stakeholders. The ongoing role of USP Expert Committees is to evaluate new data and to shape standards based on the available evidence, public input, and the Expert Committee’s expertise. USP Expert Panels are formed to provide additional input on a particular compendial topic, thereby supplementing Expert Committee expertise. They may advise one or more Expert Committees, but they are not decision-making bodies.

General Chapters Biological Analysis Expert Committee

Associated Expert Panels

  • <30> Residual DNA Testing
  • <57> Protein Determination Procedures
  • <1044> Cryopreservation
  • <1050.1> Viral Clearance
  • <1106> Immunogenicity
  • <1239> Viral Vaccines
  • <1240> Viral Testing for Human Plasma
  • Glycoprotein & Glycan Analysis
  • Glycoconjugate Vaccines Chapters
  • Immunological Test Methods
  • Recombinant Therapeutic MAbs

 

Monographs 1 Expert Committee

Associated Expert Panels

  • Epoetin
  • Glucagon
  • Insulin
  • Low Molecular Weight Heparin
  • Pharmaceutical Enzyme Preparations
  • Therapeutic Peptides
  • Unfractionated Heparin

 

Monographs 2 Expert Committee

Associated Expert Panels

  • Coagulation Factors
  • Plasma Protein Analytical
  • Tissue and Tissue-based Products