Plenary speakers

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

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

 



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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