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Biopharmaceutical Manufacturing and Development Summit

Event Information

December 08 - 09, 2008 · Washington Duke Inn & Golf Club - Durham, NC

Document Title

Event Overview

Event Overview

Mark Your Calendar

Rave Reviews from Participants:

"This conference (BMD summit 2007) is leading the path in examination of operational excellence as a new focus for the maturing biopharmaceutical industry." - James Weidner, Director, Process Engineering, Amgen, Inc.

"The BMD Summit was very informative and engaging with an excellent mix of the current trends and technologies in the biopharma industry." - Melody Scott, Process Engineer III, Biogen Idec

"The case studies presented at this conference are helpful in sharing best practices and leading the way for others to follow." - James M. Robinson, P.E., Vice President, Technical and Quality Operations, Novavax Inc.

"A good use of my time to see the latest thinking in a focused area relevant to my specific needs and interests." - Michael Kadan, Ph.D.,lMBA, Director, Manufacturing, MacroGenics, Inc.

"Great assembly of speakers." - Kim Titus, Corning

"A great combination of timely talks from end users and suppliers that rely on real world examples and experiences." - Pete Latham, President, BioPharm Services US

"Informative for the direction of disposables." - Toug Sproul, Engineer, R&D, Finesse

IBC's 3rd BMD Summit speaker program received very positive feedback from the enthusiastic attendees who also enjoyed the amenable conference facilities and enjoyable surroundings at Disney's Contemporary Resort in Orlando.

A highlight was the extremely lively keynote address given by Amgen's Vice President of Quality, Martin VanTrieste who addressed how to streamline processes and structures, enhance capacity and reduce costs. Attendees also enjoyed a novel look into the future of single use technologies in the keynote presentation from the inventor of the Wave Bioreactor(r) disposable cell culture system Vijay Singh, Ph.D., General Manager, GE Healthcare Wave Products Group.

An excellent faculty of speakers also delivered case studies of implementation of disposables with related challenges and solutions in achieving flexible facilities, and in pursuing operational excellence in raw material risk management and supply chain. New coverage of using data management, visualization and simulation to facilitate process optimization, supply chain planning and facility design provided the audience with new ways to develop more robust, cost-effective processes.

Program highlights included:

Disposables and Facilities Track

  • Biogen Idec's evaluation of disposable bioreactors
  • MacroGenics' rapid implementation of mAb manufacturing in disposable bioreactors
  • Novavax' portable manufacturing system for rapid mass production of vaccines
  • Projections for optical sensors in disposable bioreactors
  • Perspectives on disposal of disposables
  • Genentech's fast tracking approval of previously validated facilities International regulatory update on facility design
  • Avecia's strategy for integration of disposables into stainless steel plants
  • Human Genome Sciences' cost, risk and operational evaluation of fixed vs disposables for clinical manufacturing
  • New data on continuous multicolumn disposable chromatography

Operational Excellence Track

  • Update on leachables and extractables from Biogen Idec and the Global Biologics Supply Chain division of J&J
  • Wyeth's risk assessment tool for raw material and component technical evaluation
  • Genentech's strategy for control of adventitious agents in raw materials
  • Operational excellence and six sigma case studies to identify cost drivers, manage complexity and facilitate process changes
  • Abbott's strategy for qualification of suppliers and regulatory impact
  • Industry consolidation and its impact on end-users
  • Data management for process optimization and development lifecycle acceleration

Plan now to attend the next BMD Summit in the fall of 2008 on the East Coast. Please continue to check the website for updates or request more information to get the latest information on the 2008 event as it becomes available.

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