Focus Areas
Analytical Methods that Support Testing of (Glyco)Proteins and Peptides, Polysaccharides, Blood and Blood Products, Vaccines and Virology, and Cell, Gene and Tissue-Engineered Products.
Including, but not limited to:
- Quality Attributes of Recombinant Therapeutic Monoclonal Antibodies
- Immunological Test Methods
- Glycoanalysis
- Total Protein Measurement
- Peptide Mapping
- Residual DNA Measurement
- Residual Host Cell Protein Measurement
- Cryopreservation
- Viral Safety Evaluation
- Ancillary Material Qualification and Residual Testing
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Expert Committee Members
- Wesley E. Workman, Ph.D., Chair
- Anthony R. Mire-Sluis, Ph.D., Vice Chair
- Robert G. Bell, Ph.D.
- Jill A. Crouse-Zeineddini, Ph.D.
- Gary C. du Moulin, Ph.D.
- Barry D. Garfinkle, Ph.D.
- Timothy K. Hayes, Ph.D.
- Christopher Jones, Ph.D.
- Kenneth R. Miller, Ph.D.
- Elizabeth I. Read, M.D.
- Anthony A.G. Ridgway, Ph.D.
- John A. Saldanha, Ph.D.
- Junzhi Wang, Ph.D.
- Teruhide Yamaguchi, Ph.D.
- Lynn C. Yeoman, Ph.D.
Government Liaisons
- Rajesh K. Gupta, Ph.D.
- Carla S.R. Lankford, M.D., Ph.D.
- Ewa Marszal, Ph.D.
Primary Point of Contact
