3D Tissue Models
Protein Aggregation in Biopharmaceutical Products
Sheraton Boston Hotel

Boston, Massachusetts


   The study and prevention of protein aggregation and its consequences
   represents one of the most demanding tasks in biomedical research and
   pharmaceutical manufacturing today. Whether one’s interests lie in
   protein characterization or analytics, the study of protein
   aggregation-induced adverse effects or immunogenicity, or you work in
   formulation and process development for protein-based therapeutics,
   “Protein Aggregation in Biopharmaceutical Products� will provide a
   comprehensive real-world perspective on this challenging arena.

Schedule of Presentations:

Wednesday, May 19, 2010
07:00:00 Registration and Morning Coffee
08:25:00 Mechanistic Perspectives On Aggregation
08:30:00 Chairperson’s Opening Remarks David Litzinger
08:40:00 KEYNOTE PRESENTATION - Proteins, Bad Environment: The Role of Ions in Governing Stability, Solubility, and Viscosity of Proteins Yatin Gokarn
09:10:00 The Role of Physical Stress on Aggregate Formation during Processing and Storage of Biotherapeutic Proteins Mark Pollo
09:40:00 Proximity Energies and Protein Aggregation Thomas M. Laue
10:10:00 Coffee Break, Poster and Exhibit Viewing
11:10:00 Solution Factors Affecting Aggregation in a High Concentration Antibody Solution Devendra S. Kalonia
11:40:00 A Case Study of Process Stress Induced Aggregation Carl Charlie Hitscherich
12:10:00 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
13:25:00 Tools And Methods For Analysis
13:30:00 Chairperson’s Remarks Joel Richard
13:35:00 Biophysical Techniques to Explore Protein Aggregation or Aggregation Propensity Min Huang
14:05:00 Analysis of Subvisible Particles in Protein Therapeutics: Methods and Applications Shawn Cao
14:35:00 DLS Characterization of High Concentration Protein Formulations in Shelf Life Studies Kevin Mattison
15:05:00 Networking Refreshment Break, Poster and Exhibit Viewing
15:50:00 Problem Solving Break-Out Sessions
15:55:00 TABLE # 1: The Physical Properties of mAbs That Lead to Aggregation and How to Control Them Thomas M. Laue
16:05:00 TABLE # 2: Sub-visible Particles in Therapeutic Protein Formulations: Analytical and Safety Aspects Henryk Mach
16:10:00 TABLE # 3: Aggregation and Immunogenicity: Can We Identify/Characterize Aggregates That Are "Provocative" to the Immune System and How Do we Tackle Them? Joel Richard
16:20:00 TABLE # 4: New Technologies in Use or Under Investigation by Scientists Mark Pollo
16:30:00 TABLE # 5: Addressing Issues of Observed Protein Aggregation: Risk Associated with Product Quality and Immune Responses Li Shi
16:40:00 TABLE # 6: Peptide and Protein Modifications to Improve Pharmaceutical Properties David Litzinger
16:50:00 Networking Cocktail Reception in the Exhibit Hall
18:00:00 End of Day
Thursday, May 20, 2010
08:00:00 Registration and Morning Coffee
08:25:00 Approaches For Managing Or Preventing Aggregation Issues
08:30:00 Chairperson’s Opening Remarks Li Shi
08:35:00 KEYNOTE PRESENTATION - Improving Physicochemical Properties of Biopharmaceutical Drug Candidates David Litzinger
09:05:00 Protein Structure Alteration and Aggregation in Liquid Formulations: What Impact on the Drug Product Features and How to Monitor These Issues? Joel Richard
09:35:00 Case Studies of Monoclonal Antibody Aggregation: Lessons Learned from Apparently Stable Molecules Tia Estey
10:05:00 Coffee Break, Poster and Exhibit Viewing
11:05:00 Monoclonal Antibody Aggregation Intermediates Visualized by Atomic Force Microscopy Henryk Mach
11:35:00 Structure-Based Engineering of a Monoclonal Antibody for Improved Solubility Sam Wu
12:05:00 End of Conference
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