2015 BPD Header

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.


Preliminary Agenda 


NEW METHODS FOR TESTING QUALITY & STABILITY

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


RAPID SCREENING OF FORMULATION STABILITY IN EARLY DEVELOPMENT

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.


PROTEIN AGGREGATION & PARTICLE MEASUREMENTS

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.




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

For exhibit & sponsorship opportunities, please contact: 

Companies A-K:
Elizabeth Lemelin
Business Development Manager
Phone: 781-972-1342
Email: elemelin@healthtech.com 

Companies L-Z:
Sherry Johnson
Business Development Manager
Phone: 781-972-1359
Email: sjohnson@healthtech.com