January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 2nd Annual
Detection and Characterization of Particulates and Impurities
Rapid Tools and Strategies for Risk Assessment, Prediction and Characterization of Particles and Impurities from Products, Excipients and Processes
January 19-20, 2016


Particles and impurities can come from the products, any stage of bioprocessing or the packaging containers. The presence of particulates and impurities in the drug product can impact stability, safety, efficacy of the biomolecules and biologic products. Therefore, early understanding, detection and characterization of the impurities are critical to ensure safety and efficacy of the drug product for its intended duration of use. The 2nd Annual Detection and Characterization of Particulates and Impurities conference provides a platform to explore novel tools and strategies to detect, characterize and carry out risk assessment of particles and impurities.

We invite you to present a poster and join colleagues in this discussion of the key challenges and solutions for prediction, characterization, risk assessment of particles and impurities from products and processes.

Preliminary Agenda 


CHARACTERIZATION AND CONTROL
OF SUBVISIBLE PARTICLES AND AGGREGATES

Subvisible Particle Analysis: How to Invest Your Time and Resources Effectively and Improve Your Chance of Obtaining Results that Are Robust and Useful

Danny Chou, Ph.D., Senior Research Scientist I, Biologics Development, Gilead Sciences

Talk Title to be Announced

Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, United States Pharmacopeia

Visible and Subvisible Particles in BCG Immunotherapeutic Product

Marina Kirkitadze, Ph.D., MBA, Deputy Director, Analytical R&D Biochemistry, Sanofi Pasteur

Particle Identification by Multi-Technique Methods

Jonas Hoeg Thygesen, Ph.D., Research Scientist, R&D - Microanalysis Centre, Novo Nordisk Pharmatech


EXCIPIENTS-RELATED IMPURITIES: PRODUCT STABILITY
AND PARTICULATE ISSUES

Probing Protein-Surface Interactions and their Role in Particulate Formation – A Case Study

Vishal C. Nashine, Ph.D., Senior Research Investigator II, Drug Product Science & Technology, Bristol-Myers Squibb

Critical Considerations for Surfactant Stability in Biopharmaceutical Formulations

Sandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Understanding Particle Formation: Solubility of Free Fatty Acids as Polysorbate 20 Degradation Byproducts in Therapeutic Monoclonal Antibody Formulations

Nidhi Doshi, Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.


DETECTION AND CHARACTERIZATION OF PRODUCT
AND PROCESS-RELATED IMPURITIES

Identification and Characterization of Impurities in Diagnostic Proteins

Jeffrey Fishpaugh, Ph.D., Senior Principal Research Scientist, Diagnostic Analytical Chemistry R&D, Abbott Laboratories

Root Cause Analysis of Reversible Aggregates that Impact Opalescence of a Monoclonal Antibody Formulation

Radhakrishna K. Maroju, Ph.D., Scientist, CMC Management, Drug Product Development, Teva Biopharmaceuticals USA

Assessment of Protein Sensitivity to Residual Hydrogen Peroxide When Filled in Isolator

Y. John Wang, Ph.D., Principal Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.




For questions about the meeting, please contact:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute
Phone: 541-482-4709
Email: mlieberman@healthtech.com  

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email:dinerstein@healthtech.com