Quality by Design for Biologics (CQ3324)

Conference Overview

Quality by Design for Biologics 2009 tackles the challenges of effectively implementing the latest process quality and risk approaches into your own biopharmaceutical production.

KEY SPEAKERS:

  • Dr Patrick Swann, Deputy Director, Division of Monoclonal Antibodies, CDER, FDA, USA
  • Dr Ron Taticek, Director, Pharma Technical Regulatory, Genentech, USA
  • Dr Thomas Stangler, Analytical Characterization, Biopharmaceutical Operations, Sandoz GmbH, Austria
  • Dr Kuldip Sra, Prinicipal Scientist, MedImmune LLC, USA
  • Dr John Crowley, Cell Culture Team Lead, Pfizer Biotechnology Ireland, Ireland
  • Professor Nigel Jenkins, Principal Investigator, the National Institute for Bioprocessing Research & Training (NIBRT), Dublin, Ireland
  • Dr Sunil Chhatre, The Advanced Centre for Biochemical Engineering, University College London, UK
  • Dr Mary Cromwell, Director, Protein Analytical Chemistry, Genentech, USA
  • Jesús Zurdo, Head of Innovation LCM Development Serv, Lonza Biologics plc, UK
  • Dr Alan Gardner, Biopharmaceuitical Centre of Excellence, Global Manufacturing and Supply, GlaxoSmithKline, USA
  • Dr Jason Li, Director, Downstream Process Development, Genor BioPharma Co. Ltd., China
  • Dr Vatroslav Spudic, Scientist, Biopharmaceuticals, Bioprocess Development, Sandoz, Slovenia

Dr Mylène Talabardon, Senior Group Manager - Upstream Process Development, Merck Serono SA, Switzerland

Recommended Workshops

Tuesday 26 October 2010

Workshop S: How to gain a successful outcome when submitting a PAT or QbD approach to internal and external regulators

WORKSHOP LEADERS
Dr Ron Taticek, Director, Pharma Technical Regulatory (PTR), Genentech, USA & Dr Christian Valentin, Executive Director, Bioprocess R&D, Process Conception & Development, Sanofi Pasteur, France
Click Here for the full agenda

Friday 29 October 2010

Workshop W: A Practical Approach to Design Space and Design of Experiments (DoE) for Biotech

WORKSHOP LEADERS
Emil W. Ciurczak, President, Doramaxx Consulting, USA

Click Here for the full agenda

 

   
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