October 1, 2008
Implement Disposables and Operational Excellence Strategies to Optimize Facility Use and Achieve Cost and Waste Reduction
Cost pressures on the biopharmaceutical industry are mounting from domestic consumer demand, the growth of biosimilars, and emerging manufacturers around the globe. For organizations to remain competitive and gain sustainable cost reductions, they must drive innovation and accelerate their rate of implementation of novel technologies.
IBC’s fourth international BMD Summit once again provides the latest case studies, regulatory updates, and new strategies for incorporating disposables into biopharmaceutical manufacturing for the companies who continue to adopt this technology or expand their use of it. Learn how to integrate disposables into manufacturing facilities, and hear updates on facilities in general — improving flexibility, productivity, and economics of biopharmaceutical manufacturing facilities while maintaining or enhancing product quality. The biotech industry is beginning to mature and implement strategies that other industries have used such as operational excellence, continuous improvement, lean manufacturing, and six sigma. In addition, pressure is increasing to lower the costs of biotech drugs. Hear the latest strategies to save on manufacturing costs and reduce waste including design for manufacturability and process analysis.
NEW THIS YEAR
14 case studies with techniques you can use right away
Site tours to Catalent Pharma Solutions and Golden LEAF BTEC’s training facility
All attendees receive speaker materials from both tracks.
Panel Discussion: “Impact of xon the Design of Platform Processes and Facilities,” moderated by Siddharth J. Advant, PhD, principal and head of the west coast office for Tunnell Consulting
Two Tracks, Double the Opportunities
The BMD Summit is the one forum where you can gain in-depth knowledge in two complementary subject areas. Learn the newest uses for disposables, including their advantages and limitations, or learn how to apply the best principles for operational excellence to achieve lean manufacturing — or both!
During the conference you will gain a clear understanding of how manufacturing can become a strategic tool for remaining competitive in the face of industry globalization in the keynote by John Cox of Biogen Idec. Hear how to achieve results and sustain an operational excellence program in the keynote by Curran Simpson of Human Genome Sciences, Inc.
Attendees of both tracks can profit from the shared session on regulatory updates, risk management, and validation. Learn to streamline validation with a risk-based approach and inspection readiness from Genentech’s director of corporate quality and hear the inside story on risk-based commissioning and qualification experience from a former EMEA Inspections Administrator.
Track One: “Disposables and Facilities — Improving Flexibility and Plant Utilization”
Streamline validation and commissioning
Hear new data on extractables and leachables from end-users and developers
Evaluate upstream technologies to make the right choice for your program
Enhance productivity, flexibility, and economics of facilities
Track Two: “Operational Excellence — Enhancing Efficiency and Quality”
Applying lean principles to achieve cost and waste reduction
Understand raw material reuse and shelf life extension opportunities to achieve cost savings
Achieve design for manufacturability to reduce process variability
Utilize Process Analysis to Support QbD
European Colocated EventsPost-translational Modifications
11–12 November 2008
Holiday Inn Munich City Centre (Munich, Germany)
Posttranslational modifications (PTMs) play a critical role when manufacturing biologicals. Controlling their expression is the key objective of the biopharmaceutical industry in its quest to improve productivity levels and reduce time to market.
This event is the only conference in Europe to focus specifically on post-translational modifications for the biopharmaceutical industry. It unveils the latest innovations and company strategies to analyze, characterize, and control PTM expression, the effect of glycosylation on immunogenicity, and the latest cell culture methods adopted by industry to mange PTM expression. You cannot afford to miss this information.
Your global speakers include the following:
Roy Jefferis, professor of molecular immunology at the University of Birmingham (UK)
Chris Gee, senior research scientist at Medimmune (UK)
Martin Gawlitzek, senior group leader in late-stage cell culture, process research and development, at Genentech (USA)
Peter Sondermann, head of process biochemistry for Glycart Biotechnology (Switzerland)
Janine Schuurman, associate director of research at Genmab (The Netherlands)
Hans-Peter Knopf, technical project leader for Novartis Pharma (Switzerland)
Mark Schiefermeier, laboratory head for protein characterization at Sandoz (Germany)
Pauline Rudd, professor in NIRBRT at the University College Dublin (Ireland)
Dietmar Reusch, manager of development analytics at Roche Diagnostics (Germany)
…and many more. Please see our online program at www.informa-ls.com/ptm for more details.
To secure your place at this year’s event, call our booking hotline on +44 (0) 20 7017 7481 or email .
Stability Testing for Biologics
11–12 November 2008
Holiday Inn Munich City Centre (Munich, Germany)
Stability testing is essential. It is not only implemented in the biopharmaceutical development process but also applied in quality control, quality assurance, and during postmarketing studies. It has an impact on formulation, aggregation, comparability, and product packaging.
This is your chance to hear more than 16 industry and academic case studies and gain cutting edge insight into the most successful study design for your company.
Key speakers include the following:
Philip Krause, deputy director of the division of viral products at the US FDA (USA)
Jun Liu, senior scientist at Genentech (USA)
Pauline Rudd, professor in the Dublin–Oxford Glycobiology Laboratory at the University College Dublin (Ireland)
Wolfgang Fraunhofer, group leader of global pharmaceutical and analytical sciences at Abbott Bioresearch Center (USA)
Yanling Lu, research scientist at MedImmune (UK)
Timothy Schofield, senior director of nonclinical statistics at Merck Research Laboratories (USA).
See our program online at www.informa-ls.com/stabilitybio. To secure your place at this year’s event, call our booking hotline on +44 (0) 20 7017 7481 or email .
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