2010–2015 General Chapters—Biological Analysis Expert Committee

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
  • 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.
  • Lynn C. Yeoman, Ph.D.

Government Liaisons

  • Rajesh K. Gupta, Ph.D.
  • Carla S.R. Lankford, M.D., Ph.D.
  • Ewa Marszal, Ph.D.

USP Documentary Standards Staff

  • Anthony DeStefano, Ph.D.
  • Maura Kibbey, Ph.D.
  • Tina Morris, Ph.D.
  • Astrid Puch Thayer

USP Reference Standards Staff

  • Edit Chang, Ph.D.
  • Mary Crivellone, Ph.D.
  • Fabian Jameison, Ph.D.

Primary Point of Contact