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Biopharmaceutical Manufacturing and Development Summit 2007

Event Information

December 03 - 04, 2007 · Disney's Contemporary Resort · Lake Buena Vista, FL

Document Title

Event Overview

Event Overview

Latest Perspectives and Implementation Strategies of Disposables, Raw Materials and Facilities in a Unique Interdisciplinary Forum

Following on two successful BMD Summits, IBC and an advisory committee of industry leaders have developed an all-new program for 2007. This agenda brings together 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 brings you more ways to develop more robust, cost-effective processes.

Learn how to streamline processes and structures, enhance capacity and reduce costs by hearing the keynote from Amgen's Vice President of Quality, Martin VanTrieste. Plan for the future of single use technologies with new insights from the keynote presentation by the inventor of the Wave Bioreactor® disposable cell culture system and the Wave Mixer® sterile mixer system.

Choose sessions from either track to create an agenda to meet your specific information needs - and receive materials from both tracks. Plan now to attend this unique forum to help you move ahead your company's program - and your career. Register today to ensure your place.

Keynote Presentations
. Operational Excellence Benefits and Challenges
Martin VanTrieste
Vice President, Quality, Commercial Operations,
Amgen, Inc.
. The Future of the Bioreactor
Vijay Singh, Ph.D.
General Manager,
GE Healthcare Wave Products Group
Two Intensive Tracks!
Disposables and Facilities:
Improving Flexibility and Speed of Start-Up
Operational Excellence:
Enhancing Efficiency and Quality
  • 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
  • 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 evalution
  • 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 requirements
  • Industry consolidation and its impact on end-users
  • Data management for process optimization and acceleration of the development lifecycle

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