Kamalpreet Arora, Ph.D., Science & Standards Liaison—Global Biologics, firstname.lastname@example.org
Dibyendu Saha, Ph.D., Science & Standards Liaison—Global Biologics, email@example.com
Interested in learning more about the work of this Expert Committee?
Upcoming Official Meetings
- GCBA Expert Committee Meeting in Rockville, MD September 12 - 13, 2018
Past Meetings – Executive Summaries
- August 23 - 24, 2017 face-to-face meeting
- August 23–24, 2016 face-to-face meeting
- December 16–17, 2015 face-to-face meeting
- Sign up and read the latest edition of the Global Biologics e-Newsletter.
- Explore relevant workshops.
- 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.
- 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
- Residual DNA Measurement Expert Panel
- Vaccine Polysaccharide NMR Identity Testing Expert Panel
- Vaccine Subcommittee
- Validation of Commercial Test Kits Expert Panel
- Viral Vaccine Expert Panel
- Joint Subcommittee (Reference Materials)