Forced Degradation for Biologics Conference
This new event for 2010 is the only Forced Degradation event specific to biologics
Over 2 days, delegates will explore the unique challenges in carrying our fored degradation for biologics via 13 industry case studies. These cover methodologies for successful studies, troubleshooting for key problem areas, the latest analytical techniques and crucial regulatory requirements.
Highlights of Forced Degradation for Biologics
- Examine best practice for carrying out forced degradation studies read more
- Evaluating the newest anayltical techniques and bioassays read more
- Advice from the experts on challenging aspects of studies read more
- Winning strategies to deal with unexpected interactions read more
- Complying with ICH and FDA requirements for forced degradation studies read more
Homepage speakers
Homepage speakers
Dr Tapan Das
Senior Principle Scientist
Pfizer Global Biologics
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Dr Sharon Gao
Principle Scientist
Biogen Idec
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Professor Tudor Arvinte
Chairman and CEO
Therapeomic Inc
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Dr Paul Dalby
Department of Biochemical Engineering
UCL
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Dr Salman Muzammi, Head, Biophysics & Developability, Biologics Research, Johnson & Johnson, USA
Dr Peter Matthiessen, Senior Manager, Pharmaceutical Sciences & Formulation Design, Baxter Innovations GmbH, Austria
Dr John O’Hara, Characterisation Group Leader, Analytical R&D, UCB Celltech, UK
Dr Mark S. Galinski, Senior Director, Vaccine Analytical Sciences, Medimmune, USA
Dr Bernardo Perez-Ramirez, Senior Scientific Director, BioFormulations Development, Genzyme, USA
Dr Henrik Næsted, Senior Scientist, Symphogen A/S, Denmark
Dr Hui Zhao, Lab Head, Analytical R&D, Process Science and Production, Biologics, Novartis, Switzerland
Dr Yatin R. Gokarn, Associate Director, Genentech, USA
Dr Markus Tschoepe, Section Manager, Global Formulation Sciences Parenterals, Abbott GmbH & Co. KG, Germany
Dr C Jane Robinson, Principal Scientist, National Institute for Biological Standards & Control, UK
Sponsors
Pre-Conference Workshop, Tuesday 12 April 2010
Practical Approached to Forced Degradation Studies for Biologics
Don't miss this guide to the best ways to design raised temperature, freeze-thaw, light and physical stress tests. Identify the optimal times to perform forced degradation studies, compile study protocols for example biologics and use these techniques to reveal major degradation pathways.
Professor Tudor Arvinte, Therapeomic and University of Geneva, Switzerland
Dr Judy Chou, Genentech, USA
Post-Conference Workshop, Friday 15 April
Use of Forced Degradation Studies for the Validation of Stability
Indicating Methods for Biotechnology Products
Regulators are becoming more strict on the requirement that degradation methods are validated as stability-indicating. Experimental data for this are often incomplete or non-existant, but this workshop will provide attendees with the crucial skills needed for optimal product method development and validation
Dr Nadine Ritter, Biologics Consulting Group¸ USA
Evening Seminar, Wednesday 13 April 2010
Protein Aggregation: Prediction, Detection and Prevention
Our experts will guide you through data integration to help you understand and predict aggreagtion kinetics. You will learn methods for early detection of aggregates, how to assess risk levels from in-vitro data and finally to implement prevention strategies.
Dr Tapan Das, Pfizer, USA
Professor Tudor Arvinte, Therapeomic Inc, University of Geneva, Switzerland
Dates and Venues
13 Apr 2010 - 14 Apr 2010
Danubius Hotel Regents Park
Sponsors
This event will provide valuable information for senior figures in the following departments
- Analytical Services
- Quality Assurance
- Quality Control
- Stability
- Chemists
- Protein Chemists
- Formulation Development
- Pre-Clinical Development
