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Public Workshop: Scientific Issues in Assessing the
Similarity of Follow-on Protein Products
December 12 – 14, 2005
Presentations by FDA staff and other meeting participants who have given permission to post their presentations on FDA's Web site are available below.
Monday, December 12, 2005
Introduction and Goals of the Workshop
- Welcoming Remarks, Rashid Shaikh, New York Academy of Sciences
- Current Regulatory Directions, Keith Webber, FDA
- Meeting Goals and Agenda, Emily Shacter, FDA
Session I: Analytical Techniques to Examine Molecular Heterogeneity of Active Ingredient: Comparisons, Strengths and Weaknesses
Primary Structure
Session Moderator: David Bunk, NIST
- Overview of Primary Structure and Related Issues, David Bunk, NIST
- Comparative Analysis of Post-Translationally Modified Peptides and Proteins by Mass Spectrometry: New Technology and Applications, Donald F. Hunt, University of Virginia
- Chromatography Techniques, William Hancock, Northeastern University
- Fourier Transform MS, Jonathan Amster, University of Georgia
- Towards a Goal of Automated Glycoproteomic Analysis, Vernon Reinhold, University of New Hampshire
- Panel Discussion
Panel Moderator: Barry Cherney, FDA
Secondary and Tertiary Structure
Session Moderator: Blair Fraser, FDA
- Overview and Issues, Russ Middaugh, University of Kansas
- NMR, Daron Freedberg, FDA
- Spectroscopic Techniques - FTIR, Fluorescence, Other – For Secondary Structure Analysis, Keith A. Oberg, Medical Research Products – A
- Spectroscopic Techniques for Tertiary Structure Analysis, Curtis Meuse, NIST
- Thermodynamic Characterization of Protein Pharmaceutical Products by Calorimetry, Frederick P. Schwarz, NIST
- Surface Hydrophobicity/HIC, Steve Cramer, Rensselaer Polytechnic Institute
- Panel Discussion
Panel Moderators: Daron Freedberg, FDA and Curtis Meuse, NIST
Tuesday, December 13, 2005
Session I (continued)
Protein-Protein Interactions - Quaternary Structure
Session Moderator: Amy Rosenberg, FDA
- Overview and Related Issues, Amy Rosenberg, FDA
- Critical Factors Governing Aggregation of Proteins in Aqueous Solution, John F. Carpenter, University of Colorado Health Sciences Center
- Field Flow Fractionation (FFF) in Protein Purification and Characterization, Karin D. Caldwell, Uppsala University, Sweden
- Light Scattering as a Tool for Assessing Protein Aggregates, Ewa Folta-Stogniew, Yale University
- Imaging Proteins Using Atomic Force Microscopy, Roger E. Marchant, Case Western Reserve University
- Uses of Analytical Ultracentrifugation, Thomas M. Laue, University of New Hampshire
- Mass Spectrometry of Higher Order Protein Structures, Igor A. Kaltashov, University of Massachusetts at Amherst
- Panel Discussion
Panel Moderator: Barry Cherney, FDA
Session II: Effect of the Manufacturing Process on the Product
Session Moderator: Stephen Moore, FDA
Session III: Impurities and Contaminants
Session Moderator: Andrew Chang, FDA
Wednesday, December 14, 2005
Session IV: Bioassays and Potency
Session Moderator: Marjorie Shapiro, FDA
- Case Studies
Session V: Assessing Similarity of Active Ingredients
Session Moderator: Emily Shacter, FDA
- Overview of Issues, Emily Shacter, FDA
- Challenges in Developing Reference Materials for Biotech Products, Adrian Francis Bristow, National Institute for Biological Standards and Control, United Kingdom
- Roundtable Discussion - How to Compare Products/Proteins in the Absence of Reference Standards
Moderator: Emily Shacter, FDA
- Workshop Wrap-Up, Emily Shacter, FDA
- Closing Remarks, Steven Kozlowski, FDA
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Date created: June 6, 2006, updated April 5, 2007 |
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