Analysis of Protein Pharmaceuticals
A major focus of the Institute is the analysis of biopharmaceutical and biosimilars. Collaborating with the Barnett Institute can provide a competitive advantage through access to:
• Expertise and Experience in regulatory analysis
• Advanced Technologies, not available elsewhere.
• State-of-the-Art Instrumentation and Facilities
The Barnett Institute Can Support
Biopharmaceutical Development Through:
• Structural Characterization and Regulatory Analysis
– Posttranslational Modifications: level and heterogeneity
– Confirming Folded Conformation
– Glycoprotein and Glycan Analysis
– Follow-On Biologics Analysis
• Biomarker Discovery
– Surrogate Markers for Clinical Trials
– Defining Responsive Populations
– New Clinical Tests
• Mechanism of Action
• Structure-Activity Relationships
• Pharmacokinetics, Pharmacodynamics
• Biodistribution, by in vivo imaging
• Training and Certification Programs
These capabilities are being united in a new Center for Advanced Regulatory Analysis (CARA).
Short Courses in State-of-the-Art Protein Analysis and Regulatory Science
A Professional Science Masters Program in Regulatory Science, starting Sept 2010.
Expertise
Director Barry Karger (advanced LC/MS methods for comprehensive protein analysis)
Adjunct Professor Rob Garnick, Senior Vice-President of Regulatory, Quality and Compliance, Genentech, Inc. (ret.);
Professors William Hancock (glycoproteomics, M-LAC), John Engen (protein structure, HX-MS)
Research Faculty: Andraj Guttman, Marina Hincapie, Billy Wu:
extensive industrial experience.
A network of over 300 Barnett Institute Alumni, in distinguished positions in industry and academia.
• Hosted a major conference Biogenerics2008, with:
Senator Ted Kennedy, keynote address;
Heads of US FDA and counterparts in Europe and Asia, plenary lectures;
Leaders of major biotechnology and generics industries
From left: Charles DiLiberti (Barr Laboratories), Mary Alice Hefford (Health Canada), Amy Rosenberg (US FDA), Robert Garnick (Genentech), David Drake (Novartis),
Alison Lawton (Genzyme).
Advanced Techniques for Protein Analysis
ERPA Extended Range Proteomic Analysis
provides detailed characterization of previously intractable proteins, such as the 180 kDa
membrane receptor EGFR, with near-complete sequence coverage including characterization of the sites and levels of glycosylation, phosphorylation, other modifications, and degradation.
PLOT Porous Layer Open Tubular columns.
ultranarrowbore chromatography provides ultratrace limits of detection, to characterize low-level constituents
M-LAC Multiple Lectin Affinity Chromatography
isolation and separation of glycoforms of proteins
HX-MS Hydrogen Exchange Mass Spectrometry
detects changes in protein structure and dynamics upon ligand binding or activation
Instrumentation and Facilities
LTQ-FT Fourier-Transform Mass Spectrometer, hybrid with Linear Ion Trap
ETD Electron Transfer Dissociation
provides more information about glycosylation and phosphorylation modification lost using CID alone.
NMR and LC-MS-NMR
The Institute offers a level and breadth of expertise rarely found in the private sector.
For More Information, see:
List of Collaborators
Instrumentation
Research Groups
Publications
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