Biopharmaceutical Development and Production Week January 2009

IBC Life Sciences’ Biopharmaceutical Development and Production Week will help you move forward in the pharmaceutical marketplace and will address how to benchmark efforts against industry leaders and the latest strategies to overcome regulatory hurdles with in-depth, real-world case studies of the most recent advances driving the biopharm industry today.

22nd International Antibody Development and Production

On 4–6 March, IBC’s Antibody Development and Production conference will help you evaluate the latest scientific and technical approaches to successfully accelerate the development of robust processes. This event is regarded by the industry as the most comprehensive event that brings you best practices across the spectrum, including the most critical stages of upstream and downstream processing.

Keynote Presentations: “How Do We Get to 30 g/L Using Fed-Batch Technology? What Are the Limitations?” by Thomas Ryll (director of cell culture development at Biogen Idec), “Thoughts from the New Kids on the Biotherapeutics Block” by Rick Rutter (vice president of pharmaceutical sciences in biologics at Pfizer Inc.), and “Next-Generation Commercial Processes” by Timothy S. Charlebois (director of cell and molecular sciences at Wyeth BioPharma)

13th International Process Validation for Biopharmaceuticals

On 2–3 March, IBC’s 13th International Process Validation for Biopharmaceuticals will answer many questions by offering industry-leading, proven strategies to maximize your process validation efforts. With an examination of various approaches and the overall process validation lifecycle, this conference will help you discover what aspects of your validation activities warrant further or continuous evaluation.

Keynote Presentation: “Critical Quality Attributes: The Foundation of QbD and Process Validation” by Ron Taticek (director of CMC regulatory affairs at Genentech, Inc.)

5th International Outsourcing Manufacturing of Biopharmaceuticals

On 2–3 March, IBC’s 5th International Outsourcing Manufacturing of Biopharmaceuticals will help you establish new contract manufacturing approaches to stay competitive and plan for the future. Hear the latest industry advice on dealing with challenges such as managing multiple CMOs, streamlining the CMO the selection process, and overcoming new regulatory hurdles. Address tough questions surrounding safety, due diligence, and ethical supply chain management at CMOs in emerging countries — to help you decide whether outsourcing to these geographic areas is right for your company.

Keynote Presentation: “The Changing Outsourcing Landscape: Strategic Drivers and Solutions” by Arindam Bose (executive director of biologics strategy and alliances in worldwide pharmaceutical sciences at Pfizer Global R&D)

4th Annual Technology Transfer for Biopharmaceuticals

On 2–3 March, IBC’s 4th Annual Technology Transfer for Biopharmaceuticals will provide industry insights and “lessons learned” to help you to overcome the complexities and avoid pitfalls of method and process transfers. This two-day program features 14 exclusive case studies that will cover the entire life-cycle of internal, external, and international technology transfers, giving you proven approaches to ensure success.

Keynote Presentation: “Failed Tech Transfers: Learning Our Lessons the Hard Way” by E. Morrey Atkinson (director of bioprocess R&D at Eli Lilly and Company)

Inaugural Non-Antibody Protein Therapeutics Development and Production

On 4–5 March, IBC’s Non-Antibody Protein Therapeutics Development and Production conference covers development and production of molecules that do not benefit from the affinity characteristics of antibodies. You will find the solutions you need to your specific, intractable expression, purification, and production challenges.

Keynote Presentation: “Changing of the Guard? Alternatives to Animal Cells for the Expression of Therapeutic Glycoproteins” by David Robinson (executive director of bioprocess research and development at Merck & Co., Inc.)

Cell Line Development and Engineering

2–6 March 2009

Steigenberger Hotel (Berlin, Germany)

Featuring no fewer than 45 industry and academic case studies from some of industry’s most prominent speakers, this five-day event covers the most pressing issues affecting the industry, including transient expression systems, screening and clone selection, cell line stability, vector development, regulatory considerations, alternative expression systems, and cell banking. Because of overwhelming demand, 2009’s conference includes an additional day on media development, making this the “must-attend” event of the year.

Highlights

On day one, choose from two tracks. In “Implementing Successful Cell Line Strategies,” discover the current methods used by industry and academia to achieve stable and highly productive mammalian cell lines (led by Bayer Healthcare’s Baisong Mei). In “Transient Expression Systems,” find out how Florian Wurm’s laboratory is generating groundbreaking titer levels using transient gene expression — and what this will mean for the future. Discover how transient expression systems are emerging as a viable alternative to stable cell lines.

On day two, attend the “Cell Line Engineering (Regulatory Considerations and Vector Development)” track. Find out how Boehringer Ingelheim’s BI-HEX platform balances speed and quality to generate high producing cell lines. Discover how Genentech is designing and evaluating novel vector configurations to increase stability.

On day three, attend the “Cell Selection, Stability, and Alternative Cell Lines” track. Understand the factors that affect cell line productivity, as shown by Professor Sharfstein of the Rensselaer Polytechnic Institute. Professor Alan Dickson from the University of Manchester discusses amplification of recombinant CHO cell lines and the consequences for genomic structure and stability of expression during continuous culture.

On day four, attend the “Cell Engineering, Anti-Apoptosis, and RNAi” track. Professor Martin Clynes of Dublin City University reveals the latest research into mRNA and its effect on improving biopharmaceutical production systems. Discover how Sangamo BioSciences uses zinc-finger nuclease technology to increase productivity.

On day five, choose from two tracks. In “Cell Banking and Cryopreservation,” hear how to keep cross-contamination to a minimum, and learn how to organize your cell banks. Hear from the FDA on how to characterize and qualify cell substrates for viral vaccines. Or attend a fully interactive day led by Ferruccio Messi (Cell Culture Technologies) and Petra Meissner (Novartis) on “Media Development,” where you’ll learn about strategies to remove complex additives of unknown composition from mammalian cell culture media.

Key Benefits

This is the industry’s only five-day conference covering every aspect of cell line development and engineering. Hear more than 45 case studies covering all the hottest topics within this challenging area. Learn how to speed cell line development with tips from Boehringer Ingelheim, Novartis, and IBET. Discover Amgen’s selection strategies for high-productivity cell lines during early stage development. Appreciate the emergence of RNAi as a tool for improving cell line development and engineering. Hear how to efficiently prove the stability of your cell lines and gain rapid approval from the regulators. The FDA presents its view on the characterization and qualification of cell substrates for viral vaccines. Learn how Pfizer, Genentech, and Abbott optimize their transient transfection systems. What should you be doing?

Do not miss this opportunity to exchange knowledge and experiences with industry leaders and world-renowned academics to help optimise your cell line development and engineering processes.

You will have the opportunity to meet face to face with leading experts, make new business contacts, and forge strong partnerships. You can expect to meet attendees from Pfizer, Bayer Healthcare, Boehringer Ingelheim, Avecia Biologics, Lonza, Novartis, UCB Celltech, MerckSerono, Genentech, Amgen, MedImmune, and Roche.

Register early to ensure your space and to save money! Quote CQ3375BPI by phone (44-20-7017-7481), fax (44-20-7017-7823), or email (). Choose from a two-, three-, four-, or five-day pass; the longer you stay, the more you save.