Cell Line Development & Engineering

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Join Industry Leaders at IBC’s 9th Annual Cell Line Development & Engineering May 20-22, 2013 Hyatt Regency La Jolla at Aventine La Jolla, CA IBC’s Cell Line Development & Engineering conference is driven by the novel approaches and emerging tools that are designed to save you time and money during the process of selecting, developing and engineering your cell lines. In 3 information packed days, you hear experiences, successes and lessons learned from companies utilizing the rapidly expanding technology toolbox to dramatically improve the speed of cell line development, minimize risk, and increase process and product quality. Industry leaders and world-renowned academics share exclusive case studies and unpublished data, providing you with the information required to overcome your toughest challenges and help your company achieve: • The promise of ‘omics technologies in process development • High production stability with targeted integration • Improved cell density and prolonged viability with stable depletion of miR-7 • Lead candidates with optimal stability, productivity, safety and delivery characteristics from early developability assessments • Improved collaboration at the interface of development and discovery • Better understanding of gene expression regulation with next generation sequencing • Big timeline reductions through engineering of host cell line and expression vector • In process control of glycosylation during high yield production Gain Recognition from Your Peers and Present a Poster Sponsored by: IBC’s Cell Line 2013 SAFC Young Investigator Poster Awards are dedicated to recognizing the recent achievements of graduate students, post docs and research scientists that are driving this field forward. Posters are reviewed and judged by the Scientific Advisory Committee for most novel application by a graduate student, post doc and research scientist. The three winning posters will be announced during the conference on Wednesday, May 22nd at 8am. The deadline to submit an abstract for inclusion in the conference materials is Monday, April 29, 2013 (Abstract and full payment of conference and poster fees must be received by this date.) After that date, posters are on a space available basis. To submit your poster and for additional details on the poster sizes and regulations, please visit www.IBCLifeSciences.com/CellLine. Only one poster presentation will be allowed per registered attendee/author. Gold Sponsor Pall’s leading edge separation, purification, cell culture, analytical technologies and services play an essential role in the Life Sciences industry. Pall single-use and traditional filtration, chromatography, fluid handling, sampling, monitoring and quality assurance products and engineered systems, together with technical services in validation, assays and process optimization are applicable to all phases and scales of therapeutic, vaccine, and diagnostic product research, development and manufacturing. Silver Sponsor Life Technologies is a global leader in bioprocessing, supporting biologics based therapeutics and vaccines from molecule to market with leading brands such as Gibco ® cell culture products and cell therapy systems; POROS ® chromatography; and SEQ pharmaceutical analytics. Our portfolio of bioproduction services includes cell line development and media optimization. Bronze Sponsors Poster Award Sponsor Technology Workshop Sponsors Badge and Lanyard Sponsor Conference Supporter Exhibitors (as of January 11, 2013) ATR, Inc Molecular Devices Life Technologies Pall Life Sciences MaxCyte TAP Biosystems Drive Your Global Sales and Marketing IBC’s Bioprocessing Series events provide a number of sponsorship and exhibiting opportunities you can choose from to meet your goals before, during and after the event. IBC’s sponsorships ensure you the proper balance between attendees and exhibitors so you can spend more time developing your deals and less time searching for possible partners. Sponsorship/Exhibiting opportunities include Technology Workshops (including a thirty minute speaking slot); Session Sponsorships; Reception, Luncheon and Break Sponsorships; Delegate Focus Groups; Imprinted Giveaways; and much more. To learn more about sponsoring or exhibiting, please contact: A-L: Jennifer Thebodo at 508-614-1672 or jthebodo@ibcusa.com M-Z: Ellen Moorehead at (508) 614-1406 or emoorehead@ibcusa.com 2 Register Early for Best Savings • www.IBCLifeSciences.com/CellLine • 800-390-4078
Monday, May 20, 2013 7:00 Registration and Coffee 8:00 Chairwoman’s Opening Remarks – The Legal, Regulatory and Technical Landscape Laurie Donahue-Hjelle, Ph.D., Director, New Product Development, Life Technologies Keynote Addresses 8:15 CASE STUDY Coordinated Oscillations in Cortical Actin and Ca(2+) Correlate with Cycles of Vesicle Secretion The actin cortex both facilitates and hinders the exocytosis of secretory granules. How cells consolidate these two opposing roles was not well understood. Here we show using multi-color fluorescent microscopy that antigen activation of mast cells induces oscillations in Ca(2+) and PtdIns(4,5)P(2) lipid levels that in turn drive cyclic recruitment of N-WASP and cortical actin level oscillations. These oscillations increase secretion efficiency, explaining how the actin cortex can function as a carrier as well as barrier for vesicle secretion. Roy Wollman, Ph.D., Assistant Professor, Chemistry and Biochemistry, University of California San Diego 8:45 CASE STUDY • UNPUBLISHED DATA Higher-Faster-Further: Why It Makes Sense to Invest in Innovation to Achieve Disruptive Improvements – A Case Study About 2nd Generation Media Development The pressure to reduce COGS will likely increase. The biopharmaceutical industry needs to pro-actively address this development by having the appropriate strategies to increase productivity significantly. This requires a dedicated commitment to innovative ideas that include state of the art scientific approaches for significant improvements. The case study correlates the investment in innovation with the outcome of a multi-year innovation project. Torsten W. Schulz, Ph.D., Director, Cell Culture, Boehringer Ingelheim Fremont, Inc. 9:15 Speed Networking Refreshment Break and Poster/Exhibit Viewing Working Closer with Drug Discovery and Research to Improve Cell Line Development and Minimize Risk 10:15 UNPUBLISHED DATA Cell Line Development for Novel Molecules - Perspectives from the Interface of Discovery and Development Abstract not available at time of print. Please visit www.IBCLifeSciences.com/CellLine for updates. Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie 10:45 CASE STUDY • UNPUBLISHED DATA Molecular Assessment (MA) Programs – Balancing Upstream Work with Downstream Payoffs Producing recombinant proteins and antibodies with manufacturability problems often presents a significant barrier to the clinical and commercial feasibility of a project. Methods to identify problematic molecules early in the drug development process can serve a valuable purpose by either eliminating these molecules from consideration or by providing advance notice so that proactive steps can be taken to minimize timeline delays. This presentation describes selected Molecule Assessment (MA) considerations implemented at Genentech, highlighting examples identified at different stages in the process. Laura Simmons, Senior Scientist, Early Stage Cell Culture, Genentech, Inc. “Quite worthwhile! Informative, encompassing, broad and yet relevant topics. Great venue for discussion and interaction.” - Lynn Davis, Ph.D., Senior Research Biologist, Bend Research Inc. 11:15 CASE STUDY • UNPUBLISHED DATA Surviving the Valley of Death - Pre- Cell Line Generation Strategies to Reduce Attrition in Later Stages of Biopharmaceutical Development The majority of new biopharmaceutical candidates fail during preclinical and clinical development in what some describe as the ‘valley of death’ of drug development. The challenge faced by drug developers is to find new ways of screening out early on in development those compounds that have a lower probability of success. Developability strategies applied before the development of production cell lines do address aspects of manufacturability, safety and delivery that could impact negatively later stages of development. They constitute an alternative approach to QbD, targeting risks present in the product itself. It is expected that the incorporation of this type of assessment early on in biopharmaceutical development will help reduce cost, attrition and development timelines. Jesús Zurdo, Ph.D., Head of Innovation, Biopharmaceutical Development, Lonza, United Kingdom 11:45 Technology Workshop Simple Methods to Make Your Cell Line Shine Tremendous efforts have gone into shortening stable cell line development. Once those months are invested, there is a desire for the selected clone to shine very quickly with regards to titer and sustainable product quality. This presentation will explore simple methods to attain next level titers in CHO fed-batch processes once you’ve selected your expression clone. Cynthia Hoy, Ph.D, Process Science Fellow, PD Direct® Services – Life Technologies 12:15 Luncheon and Poster/Exhibit Viewing 1:15 Chairman’s Remarks - Are ‘omics Approaches Anything other than Intellectual (Academic) Interest - Does Data Obtained have Track Record of Translating to Making a Difference in Processes Kevin McCarthy, Ph.D., Group Leader for Cell Sciences, EMD Serono Inc. Application, Integration and Characterization of ‘Omics in Cell Line Development 1:30 UNPUBLISHED DATA Application of Genomic Technologies to Cell Line Development The recent publication of a draft CHO genome has set the stage for detailed molecular and genetic understanding of growth and protein production in mammalian cells, which will enable - the recognition of patterns of gene expression that correlate to process suitability and allow knowledge based selection of clones; development of pathway engineering strategies to improve the host cell line; process, media and feed development by optimisation of cellular responses. Nicole Borth, Ph.D., Professor, Department of Biotechnology, University of Bodenkultur, Austria 2:00 UNPUBLISHED DATA Development of a CHO Mass Spectrometry Database New sequence information on Chinese hamster ovary cells offers the potential to improve the interpretation of CHO proteomic results, and thus a greater understanding of the underlying biological mechanisms of CHO cells in biopharmaceutical processes. In this presentation, we demonstrate the use of CHO-specific sequence information to improve the identification of CHO proteins using mass spectrometry-based proteomic analysis. Paula Meleady, Ph.D., Senior Research Scientist, Program Leader, Proteomics Core Facility, National Institute for Cellular Biotechnology, Dublin City University, Ireland 2:30 UNPUBLISHED DATA Engineering the CHO Genome for Improved Transgene Integration and Expression Epigenetic regulatory DNA elements prevent silencing and increase transgene integration and transcription for high and stable therapeutic production. We have sequenced the genome and transcriptome of a CHO cell line and of derived producer cell clones, yielding information on the integration locus, transgene integrity and copy number. Information on possible mechanisms allowing vector genomic integration was also obtained, providing approaches to further optimize transgene integration and expression. Nicolas Mermod, Ph.D., Professor, Director, Institute of Biotechnology, University of Lausanne, Switzerland For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 3
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