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 We are seeking case studies, especially unpublished and innovative work, on the use of the effective scale-up strategies, excipient induced instability, process challenges, fill finish challenges, and predictive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.

Preliminary Agenda


EXCIPIENTS & SURFACTANT STABILITY IN BIOPHARMACEUTICAL FORMULATIONS

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.


PROCESS ATTRIBUTES, PLATFORM APPROACH & PRODUCT QUALITY

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 NEW MODALITIES & PROCESS OPTIMIZATION

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


CHALLENGES OF LOW CONCENTRATION FORMULATIONS

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.




For more details on the conference, please contact:
Nandini Kashyap
Conference Director
Phone: 781-972-5406
Email: nkashyap@healthtech.com

For media partnership opportunities, please contact:
Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419
Email: kchaudhuri@healthtech.com

For exhibit & sponsorship opportunities, please contact:

Companies A-K
Sherry Johnson
Business Development Manager
Phone: 781-972-1359
Email: sjohnson@cambridgeinnovationinstitute.com

Companies L-Z
Carolyn Benton
Business Development Manager
Phone: 781-972-5412
Email: cbenton@healthtech.com

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Event at a Glance
Event at a Glance


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