Single-Use Applications for Biopharmaceutical Manufacturing

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As single-use products are increasingly implemented, end-users are exploring applications, designing system approaches, assessing suitability and economics, and demanding expanded capabilities. Industry experts say that the single-use market is now moving into its next phase in which suppliers and developers are being challenged to not only “step up” and offer larger scale options, but also to provide additional downstream capabilities.

IBC’s 5th International Single-Use Applications for Biopharmaceutical Manufacturing conference will provide over two days of current knowledge and strategies to ensure maximum use and efficiency of single-use systems, while minimizing investments and increasing speed time to clinic. Conference delegates will explore and analyze the latest advancements being made in downstream processing and will hear industry assessments of the latest bioreactors and probes on the market, including fully disposable perfusion bioreactors. Attendees will gain a full range of market knowledge, including the current and future landscape of single-use manufacturing, and the skills and knowledge necessary to minimize regulatory burdens and establish strategies to meet evolving business needs.

The scientific advisory board, along with the distinguished faculty, will present the most recent tools and technologies through numerous end-user implementation case studies.

In addition, a tactical audience interactive panel has been designed to help reveal the behind-the-scenes procedures of vendor testing methods.

New This Year

Implementation Case Studies: This year’s conference will provide the opportunity to learn from real-world experiences of single-use implementation in 10 industry case studies including downstream advancements, bioreactors, and sensors, presented by industry leaders including Amgen, Bayer, Eli Lilly, Genentech, and Wyeth.

Critical Evaluation: Conference delegates will have the chance to hear an extensive critical evaluation of tube welder technologies from Bayer Healthcare and find out which one they implemented.

Preconference Workshop: “Disposing of Single-Use Systems: A Comprehensive Review of Strategies and Best Practices” will provide insight into this aspect of disposable systems use. The featured talk in the workshop is “Analyzing the Carbon Footprint Left By a Company’s Use of Disposables.”

Highlights

Single-Use Systems — A Strategic Look Ahead: This keynote presentation by Russell Wong, PhD, senior process development engineer, manufacturing sciences, Bayer Healthcare, will provide key insights on the future direction of the industry based on current technology needs, quality/regulatory initiatives, and the historic basis for the single-use industry’s growth.

Successfully Working in Tandem With Your QA Department: This Featured Presentation by Adam Goldstein, senior manager of operations, Genentech, Inc. (Oceanside, CA), will provide advice on partnering with your quality department to determine the use points for disposables and what tests should be performed in the planning phase of the implementation process.

Unraveling Various Vendor Testing Methods: This audience interactive panel will stimulate discussion between end-users and top vendors highlighting whether various vendor tests and methods meet end-user needs. Moderator and panelists representing Bristol-Myers Squibb & Company, Genentech, Inc., BPSA, Pall Life Sciences, and Stedim Biosystems.

Additional Opportunities

  • Benefit from an entire session dedicated to analyzing how the latest downstream advancements are impacting the industry

  • Watch “Technology Idol 2008” as participants present the latest technologies from manufacturers of single-use equipment or systems

  • Tour Genentech, Inc.’s Oceanside Plant — named the “2007 ISPE Facility of the Year”

Session Titles

  • Assessing the Current Industry Landscape with an Eye on the Future

  • The Latest Downstream Advances and the Impact on Production and Economics

  • Evaluating Single-Use Bioreactors and Sensors: Factors to Consider

  • Single-Use Manufacturing: The Economics, the Risks, and the Quality

European Featured Events

Transmissible Spongiform Encephalopathies

25–26 June 2008

Corinthia Towers Hotel, Prague, Czech Republic



Informa Life Sciences’ third annual Transmissible Spongiform Encephalopathies (TSE) conference program uniquely tailors the latest updates on TSE diseases and outlines risk assessments for vaccine manufacture, antibody production, and plasma-derived products to address the specific needs and challenges of the biopharmaceutical industry. This year’s two-day, case-study driven program will help you discover how to increase your yield and product quality without sacrificing the safety of your raw materials.

The 2008 program shares the technological progress in TSE detection tests, delivering an in-depth update on advances in cell culture development and antemortem diagnosis. Industry experts will illustrate through in-depth case studies how they select and prepare their spike material for TSE removal and evaluate methods available for decontamination of biomanufacturing instruments.

Highlights

  • Gianluigi Zanusso, PhD, professor, University of Verona, will speak about bovine amyloidotic spongiform encephalopathy and its potential risk to humans.

  • A vital update on the EMEA guideline on TSE safety will be presented from the Paul-Ehrlich-Institut, Germany.

  • Claudio Soto, PhD, professor, University of Texas Medical Branch, USA will review his findings for the replication, detection and creation of infectious prions.

  • CSL Behring will discuss aspects of the impact of spike preparation and methods for prion quantification on reduction factors.

  • Maurizio Pocchiari, PhD, professor, Instituto Superiore di Sanita, Italy, reviews soluble infectivity for studying clearance of prions during plasma fractionation

  • Gerald S Baron, PhD, Rocky Mountain Laboratories, NIAID, NIH, USA, presents the mechanisms of infection and spread of prions.

Postconference Workshop

Stay an extra day in Prague for the full picture of TSE and viral safety requirements throughout the production process at the postconference workshop “Viral and TSE Safety Requirements: From Phase I through to Marketed Product.” This-full day, interactive workshop will focus on virus and prion safety requirements for a range of products as they pass through early development, clinical trials and finally to marketed product.

Please quote VIP Code: CQ3353BPIAD. Call booking hotline on +44-20-7017-7481; www.informa-Is.com/tse

Recombinant Antibodies

24–26 June 2008 Clontarf Castle Hotel, Dublin, Ireland

Informa Life Sciences is proud to announce the return of the Recombinant Antibodies meeting. T
his premier conference assembles global representatives from industrial, academic, and commercial organizations to discuss the potential of antibody therapeutics, specifically the latest innovations and developments.

Featured Speakers

Mike Clark, PhD, reader in therapeutic and molecular immunology, University of Cambridge, UK

Paul Carter, PhD, Seattle Genetics, USA

Sally Ward, PhD, professor, University of Texas Southwestern Medical Center, USA

Dario Neri, PhD, professor in the department of chemistry and applied bioscience, Swiss Federal Institute of Technology, Switzerland

Richard Stebbings, PhD, principal scientist in the biotherapeutics group, NIBSC, UK

Armin Sepp, PhD, investigator of biopharm CEDD, Domantis Limited, UK

Horst Lindhofer, PhD, CEO, TRION Pharma GmbH, Germany

Tristan Vaughan, PhD, director of lead generation, Medlmmune, UK

Lucien Aarden, PhD, professor in Sanquin Research, University of Amsterdam, The Netherlands

George Dunn III, PhD, senior research scientist, Centocor Research and Development, USA

What’s new for 2008?

Immunogenicity: Explore successful design and validation of assays, predicting and reducing immunogenicity, understanding the failure of preclinical safety testing and the disastrous phase 1 clinical trial of TGN1412 — unique case studies with clinical consequences and postmarketing considerations.

Fusion Proteins and Dual Targeting: Learn from experience with first-in-man clinical trials, human antibody RNase fusion protein targeting CD30+ lymphomas, and hybrid protein engineering.

Antibody–Drug Conjugates: Hear about the design and preclinical performance of lgG and antibody fragment conjugates with auristatins, including improvements in therapeutic index from Seattle Genetics.

Formulation and Drug Delivery: Learn about novel delivery of antibody fragments and how to formulate your antibody to enhance drug delivery.

Please quote your VIP Code: CQ2179BPIAD to save up to £300 if you book before 23 May 2008, call our booking hotline on +44-20-7017-7481 or email ;

www.informa-ls.com/antibodies.

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