Cambridge Healthtech Institute’s Fifth Annual
Overcoming Formulation Challenges for Biopharmaceutical Development:
Formulation and Process Optimization, Excipients, Analytics and Device Integration
Part of CHI's Ninth Annual The Bioprocessing Summit
August 21-22, 2017 | Westin Copley Place | Boston, MA
The popular fifth annual Overcoming Formulation Challenges for Biopharmaceutical Development conference will cover latest trends and challenges in biologic formulations development, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. We are seeking case studies, especially unpublished and innovative work, on the use of the effective scale-up strategies, excipient induced instability, process challenges, fill finish challenges, and predictive tools for rapid formulation and stability screening.
Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations
Andrea Hawe, Ph.D., CSO, Coriolis Pharma
Resolution of Surfactant Issue in Biologics Formulations
Sandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.
Polysorbate Interactions with Monoclonal Antibodies as Probed by 2D NMR
Krishna M.G. Mallela, Ph.D., Associate Professor of Biophysical Chemistry, Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus
Understanding the Impact of Histidine and Polysorbate 20 Degradation in Stainless Steel Containers on Protein Aggregation and Stability
Adithi Chandrasekhara, Research Associate, Late Stage Pharmaceutical Development, Genentech, Inc.
Impact of Formulation and Process Attributes on Protein Aggregation
Ashlesha S. Raut, Ph.D., Senior Scientist, Biologics and Vaccine Formulation, Merck
Aggregation due to Shear Stress and Surface Interaction: Molecule Specific or Universal Phenomenon
Tatiana Nanda, Ph.D., Biopharm Product Development Investigator, Biopharm Product Sciences, GlaxoSmithKline
Challenges in Handling of the Platform Formulations from Development through Marketing Application
Radhakrishna Maroju, Ph.D., Senior Scientist, Biologics CMC, Teva Biopharmaceuticals USA
Lyophilization of ADCs Containing Highly Potent Cytotoxic Agents
Amit Gangar, Ph.D., Scientist I, Drug Product and Process Development, Immunogen, Inc.
Investigation of Fogging/Haze Behavior in Lyophilized Drug Product
Min Huang, Ph.D., Principal Scientist, Pharmaceutical Research and Development, Pfizer, Inc.
Lyophilization Process Optimization and Identification of Design Space for Monoclonal Antibody Formulation Using Definitive Screening Design
Haresh T. More, Ph.D., Research Investigator I, Parenteral Science and Technology, Bristol-Myers Squibb
Transformational Science: Moving from Challenges of High Concentration Protein Formulations Development to Meet the Needs of Highly Potent Bispecifics
Sachin Dubey, Ph.D., Head of Formulation Development, Process Development, Glenmark Pharmaceuticals SA
Intravenous Administration of Low Concentration Protein Formulations: Challenges and Approaches
Ian Lent, MS, Development Associate II, MacroGenics, Inc.
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