Cambridge Healthtech Institute’s 3rd Annual
Rapid Methods to Assess Quality & Stability of Biologics:
Improving Prediction and Screening
August 3-4, 2015
Part of CHI's 7th Annual The Bioprocessing Summit
August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts
Assurance of quality and stability of biologic formulations over the course of intended usage is critical in developing safe and efficacious biopharmaceutical products. Increasing regulatory expectations and aggressive development timelines calls for the need of rapid methodologies to predict and assess the quality and stability of biologics. The third annual Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss regulatory expectations, prediction and manipulation for protein stability and instabilities cause by particles and impurities. We invite you to attend to learn from and network with the leading experts from around the world.
Emerging Technology for Biologics Stability Testing
Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company
A Unique High-Throughput Assay for Determination of the Potency and Stability of Biologics
Michael Tovey, Ph.D., INSERM Director of Research, Laboratory of Biotechnology and applied Pharmacology, Ecole Normale Supérieure de Cachan, France
Analytical Testing Strategy for Admixture Testing of Therapeutic
Shenjiang Yu, Ph.D., Associate Principal Scientist, Sterile Product and Method Development, MRL, Merck Co. & Inc.
Challenges to Implementing High Throughput Methods in a QC Environment
Michelle Joubert, Staff Scientist, Genzyme, a Sanofi Company
A Novel Analytical Approach to Investigate the Effect of Methionine Oxidation on Antibody PK
Jan Stracke, Ph.D., Principal Scientist, Pharmaceutical Development & Supplies, PTD Biologics Europe, F. Hoffmann-La Roche Ltd.
HDX-MS Sheds Mechanistic Insights on Mutation Induced Changes in Physical Stability of an IgG1 mAb Engineered For Extended Serum Half-Life
Ranajoy Majumdar, Ph.D., Research Scientist, Biophysical Characterization, Biopharmaceutical Research and Development, Eli Lilly and Company
A Comparison of Biophysical Characterization Techniques in Predicting Drug Product Stability
Geetha Thiagarajan, Ph.D., Senior Scientist, Sterile Product and Analytical Development, Merck & Co.
Stability Challenges for Protein Therapeutics: Anticipating Aggregation Phenomena at Early Development Stage
Joël Richard, Ph.D., Senior Vice President Peptides, Technical Operations, Ipsen
Strategy for Characterization and Control of Submicron and Subvisible Particles in Biologics
Nataliya Afonina, Ph.D., President and Principle Consultant, AN Biologics Consulting LLC
Addressing the Gaps in Particle Measurements for Biotherapeutic Solutions
Reema Raghavendra, M.S., MBA, Scientist II, Global Protein Sciences, AbbVie, Inc.
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