Contact
- 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
Interested in learning more about the work of this Expert Committee?
Download Roster Observe a Meeting
Upcoming Official Meetings
- SAVE THE DATE! September 16–17, 2019, at USP–U.S., Rockville, MD
Past Meetings – Executive Summaries
Latest Updates
- Sign up and read the latest edition of the Global Biologics e-Newsletter.
- Explore relevant workshops.
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
- Validation of Commercial Test Kits Expert Panel
- Viral Vaccine Expert Panel
- Joint Subcommittee (Reference Materials)