2015–2020 General Chapters - Biological Analysis Expert Committee Work Plan


  • Shy Bhattacharya, Ph.D., Associate Science & Standards Liaison – Global Biologics, shy.bhattacharya@USP.org
  • Dibyendu Saha, Ph.D., Science & Standards Liaison—Global Biologics, dqs@usp.org

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Focus Areas

  • Physicochemical characterization of proteins and natural products
  • Vaccine characterization
  • Stability testing
  • Cell banking
  • Measurement of process and product-related impurities
  • Validation of test kits

Expert Committee Charge

The General Chapters – Biological Analysis Expert Committee is responsible for the development and revision of USP-NF chapters and their associated USP Reference Standards that support therapeutic biologics as well as ancillary materials and reagents used for production of biologics. The Expert Committee is also charged with the development and revision of vaccine monographs and supporting analytical general chapters.

Key Issues

  • Work with other Biologics & Biotechnology Expert Committees, FDA, and stakeholders to improve existing general chapters for analytical methods and vaccine product classes

Subgroups and Expert Panels

  • Biologics Stability Expert Panel
  • Cell Banking Expert Panel
  • Peptide Mapping Subcommittee
  • Vaccine Polysaccharide NMR Identity Testing Expert Panel
  • Vaccine Subcommittee
  • Viral Vaccine Expert Panel
  • Joint Subcommittee (Reference Materials)

Standards Development