Plenary

                    

Dr Lynne Krummen Senior Director, Pharma Technical Regulatory Genentech, USA




2010 Keynote Speakers

Dr Patrick Swann Deputy Director, Division of Monoclonal Antibodies FDA, USA

Dr Ron Taticek Director, Biologics Development & QbD, Pharma Technical Regulator Genentech, USA

Professor John R. Engen Associate Professor of Chemistry & Chemical Biology Northeastern University, USA

  

Speakers


Dr Anthony Rossomando Senior Director, Biotherapeutics/Bioprocessing, Alnylam Biotherapeutics, USA

EXCLUSIVE KEYNOTE interview, click here




BENEFITS OF ATTENDING

  • 4 conferences - 1 flexible event
  • Dedicated networking time
    More dedicated networking time to provide you with the perfect platform to share your experiences and make new contacts with senior level attendees.
  • 350+ attendees
    350+ bioprocessing scientists, managers and directors in one venue over 2 full days
  • Case Studies and Exhibitions
    60 case studies from leading biomanufacturing companies
    Network in the exhibition hall with 35+ exhibitor and sponsor companies
  • Online Networking
    Back by popular demand! Online networking, allowing you to contact pre-registered attendees before, during and after the event.
Attend any talk from any conference and design a programme tailored to your specific information needs.

 
Topical Plenary Session:
 
·      Dr Lynne Krummen from Genenetch will give an overview of the role of the A-Mab case study, well as the FDA’s biotech pilot program and other Health Authority interactions, in driving implementation of QbD in the biologics arena.
 
·       In what is meant to be the “decade for RNAi”, find out how this technology is being applied in bioprocessing to optimise and improve the production of biologics – Dr Anthony Rossomando of Alnylam Biotherapeutics reveals all

Programme Highlights

  • Dr Patrick Swann from the FDA and Dr Ron Taticek, Genentech will discuss some initial lessons learned from the US FDA pilot programme on the application of QBD
  • Dr Paul McCormac, Pfizer reveals how he managed a multi-site network and implementation strategy
  • Genentech reveals best practices for transferring cell culture processes, both internally and externally
  • Improve your understanding of Higher Order Stuctures, the best methods to analyse them and their role in comparability studies John Engen reveals latest HX-MS data
  • Discover how to successfully take QbD from concept to reality with an actual case study from development through to preparing for BLA filing from Dr John Crowley, Pfizer
  • Bridge the gap between analytics and process development with case studies from Genzyme, Merck, MedImmune and Boehringer Ingelhem
  • The design of a new facility dedicated to streamline production of a MAb clinical supply using nearly 100% disposable technology will be revealed from Dr Olivier Cochet, Pierre Fabre
 
   
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