Cambridge Healthtech Institute’s Third Annual
Higher-Order Protein Structure
Characterization, Prediction, Comparability and Biosimilars
Part of CHI’s 6th Annual The Bioprocessing Summit
August 21-22, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts
Understanding of the biomolecular structure of proteins is of high importance in drug development process. Biophysical properties such as protein dynamics, conformation, self-association, aggregation and particulate formation affect the quality attributes of protein therapeutics. Detailed knowledge and characterization of the underlying proteins and their behavior thus enables assessment of how protein structure is affected by manufacturing, storage, handling and delivery; and, in turn, allows researchers to better determine the impact on safety and efficacy.
This popular annual conference will feature informative, high-quality case studies and successful strategies to overcome the problems you are facing in the rapidly changing higher-order protein structure landscape. We invite you to attend to learn from and network with the leading experts from around the world.
Measuring Higher Order Structure of Proteins: Rationale, Methodologies and Expected Outcomes
Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India
Qualification of Analytical Method Used for Characterization of Protein Higher-Order Structure
Marina Kirkitadze, Ph.D., Deputy Director, Analytical Research & Development, Sanofi Pasteur, Canada
Regulatory Considerations to Demonstrate Analytical Comparability & Biosimilarity
Maria-Teresa Gutierrez-Lugo, Ph.D., Product Quality Reviewer, Division of Therapeutic Proteins, OBP/Center for Drug Evaluation and Research, US Food and Drug Administration
Assessing Aggregate Content in Originator Products as a Specification Guideline for Biosimilars
Christina R. Vessely, Associate Director, Merck & Co.
NMR Fingerprinting the Higher-Order Structure of Biosimilars: A High-Resolution Comparability Tool
Yves Aubin, Ph.D., Research Scientist, Protein Structure and Analysis Laboratories, Biologics and Genetic Therapies Directorate, Health Canada [Invited]
Application of High-Resolution UPLC-MS in Drug Product Comparability Studies
Yimin Hua, Ph.D., Quality Control Scientist I, Genzyme Corporation, a Sanofi Company
Adopting Imaging and Other Techniques to Study Novel Therapeutic Modes Such as the DVD-IgTM Molecule
Ivan R. Correia, MBA, Ph.D., Senior Principal Research Scientist, Protein Analytics, Process Sciences, AbbVie Bioresearch Cente.
Site-Directed Spin Labeling to Assess Higher-Order Protein Structure
Lawrence Berliner Ph.D., Professor of Chemistry and Biochemistry, Chemistry and Biochemistry, University of Denver; Emeritus, Ohio State University
Evaluation of Vibrational Spectroscopic Techniques for Structural Characterization of a Therapeutic Monoclonal Antibody in Formulation Matrix
Geetha Thiagarajan, Ph.D., Senior Scientist, Sterile Product and Analytical Development, Merck & Co.
Advantages of Hydrogen Deuterium Exchange Mass Spectrometry in Understanding Multi-Domain Proteins
Thomas E. Wales, Ph.D., Research Assistant Professor, Department of Chemistry and Chemical Biology The Barnett Institute of Chemical and Biological Analysis, Northeastern University
Talk Title to be Announced
Speaker to be Announced, Analytical Development and Analytical Development and Characterization, Merck Serono (Italy)