Cambridge Healthtech Institute’s Second Annual
Rapid Methods to Assess Quality & Stability of Biologics
Improving Prediction and Screening
Part of CHI’s 6th Annual The Bioprocessing Summit
August 18-19, 2014 | Renaissance Waterfront 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 biologic formulations. This second annual conference will discuss regulatory expectations, prediction and manipulation for protein stability and key aspects of thermodynamic stability. It will also discuss real-time and accelerated stability studies and effective use of deign of experiment for assessment and data comparability from early to late stage development. We invite you to attend to learn from and network with the leading experts from around the world.
Quality by Design Method Development Using a Platform Approach for Multiple Commercial Biological Products
Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company
Recent Advances in Monitoring Protein Aggregation Kinetics and Mechanisms with Simultaneous Multiple Sample Light Scattering (SMSLS)
Wayne F. Reed, Ph.D., Murchison Mallory Chair Professor of Physics, Department of Physics, Tulane University
Rapid Analytical Techniques for the Commercial Quality Control Laboratories in Preparation for Regulatory Filings
Paul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc.
Evaluation of the Stability of Low-Concentration Maytansinoid ADCs in Infusion Bags and Their Compatibilities with Administration Sets
Joyce Lin, Sr. Analytical Associate, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.
Alternative Methods for Quantifying Temperature- And Formulation-Dependent Aggregation Rates
Christopher J. Roberts, Associate Professor, Department of Chemical & Biomolecular Engineering, University of Delaware
The Measurement of KD at Low Concentration and Its Application as a High-Throughput Screening Technique for Protein -Protein Interaction Measurements
Anthony L. Young, Ph.D., Principal Scientist, Pharmaceutical Research and Development Pfizer
Increasing the Throughput of Protein Formulation Screening Using 96-Well Plate Format
Qingyan Hu, Scientist, Ph.D., Scientist , Formulation Development, Regeneron, Inc.
Using High-Throughput Screening Methods to Screen Excipients during Formulation Development
Jamie Biddlecombe, Scientist II, Formulation Sciences, MedImmune UK
Application of DSF as a High-Throughput Tool in Protein Characterization and Formulation Development
Shuai "Sunny" Shi, Ph.D., Senior Scientist, Sterile Product Development, Merck
Additional Sponsored Presentation by BIA Separations
Breakout Discussions are facilitated, small-group discussions which encourage interactive participation leading to problem-solving and future collaborations around focused topics. Each breakout discussion will be facilitated by a moderator. Attendees can choose to join any topic table they prefer.