Cell Line Development & Engineering

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6:00 Dinner Symposium (Special registration required) Tuesday, May 21, 2013 (continued) Please join us for this highly interactive 3 hour evening exchange in a roundtable format, which encourages participants to share their experiences and concerns amongst several discussion topics that include: What Is the State-of-the-Art in Expression Are We Hitting Our Limits Moderators: Laurie Donahue-Hjelle, Ph.D., Director, New Product Development, Life Technologies Andrew Racher, Ph.D., Head of Process Development Sciences, Lonza Biologics plc, United Kingdom Are There Any Emerging Platforms that Could Supersede CHO Moderators: Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc. Jesús Zurdo, Ph.D., Head of Innovation, Biopharmaceutical Development, Lonza, United Kingdom How Do We Leverage the CHO Genome Info Moderators: Kelvin Lee, Ph.D., Gore Professor of Chemical Engineering, Delaware Biotechnology Institute Faculty Fellow, University of Delaware Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals, Professor of Biotechnology, University of Manchester, United Kingdom Viral Risk Mitigation Strategies Moderators: Andy Lin, Ph.D., Process Research & Development, Genentech, Inc. Pamela Hawley-Nelson, Ph.D., Associate Director, Process Cell Culture, MedImmune Inc Phase-Appropriate, Regulatory Expectations Regarding Cell Line and Cell Culture Processes (Bulk Culture, Non-GMP for First Human Dose (FHD)) Moderators: Luhong He, Ph.D., Senior Research Scientist, Eli Lilly and Company Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie Agenda: 6:00-7:00 pm Discussion Groups 7:00-8:00 pm Dinner 8:00-9:00 pm Dessert and summaries from each discussion Additional registration fee required – see page 7 for details Wednesday, May 22, 2013 7:30 Coffee 8:00 Chairman’s Remarks and Announcement of Poster Winners Kevin J. Kayser, Ph.D., Director, Cell Sciences and Development, SAFC Applying Disruptive Technologies and Their Impact on Cell Line Development and Engineering 8:15 Cell Line Engineering Applications of Zinc Finger Nuclease(ZFN) Technology to Reduce the Risk Profile in Therapeutic Manufacturing Processes Zinc Finger Nucleases (ZFNs) are a class of engineered DNA-binding proteins that facilitate targeted editing of the genome by creating double-strand breaks in DNA at user-specified locations. We have conducted significant research and development work to deploy ZFN technology across biopharmaceutical applications. SAFC has created several new commercial available Chinese Hamster Ovary (CHO) cell lines with modifications in specific genes of interest. Example cell lines include CHO GS-/- and CHO dhfr-/- deletions. This talk begins with an overview of the ZFN technology and specific CHO cell line engineering applications but focuses on current research to create CHO cell lines with reduced risk profiles. Kevin J. Kayser, Ph.D., Director, Cell Sciences and Development, SAFC 8:45 UNPUBLISHED DATA Next Generation Sequencing Technologies and Applications in Biomanufacturing The rapid pace of development of technologies for high throughput analysis of nucleic acid sequence information is beginning to have an important impact on cell line development. In this presentation, we discuss an overview of the variety of next generation sequencing technologies that are available and being employed to study mammalian cell lines and discuss impact of the application of these technologies to problems relevant to the biomanufacturing community. Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Director of the Delaware Biotechnology Institute, University of Delaware 9:15 CASE STUDY • UNPUBLISHED DATA Generic Characterization of Stable CHO Lines by Next Generation Sequencing One of the major challenges in biologic drug development is product heterogeneity as a result of contamination, mutation or alternative splicing in transcription. Traditional methods such as cloning and Sanger sequencing, etc. are inefficient and even incompetent in detection of generic variants, especially in low amount. NGS, a powerful tool in decipher genetic information, was applied on the task and was demonstrated as a perfect fit in molecular characterization of biotherapeutics during drug development. Junjian Liu, Ph.D., Senior Scientist, Global Biologics, Abbott Laboratories 9:45 Networking Refreshment Break Featured Presentations – Applying Novel Development & Engineering Strategies 10:15 Stable Depletion of miR-7 Expression for Improved Performance of a CHO Batch-Fed Culture MicroRNAs are an important group of cellular genetic regulators that display several attractive traits as engineering targets. Their ability to influence the expression of multiple proteins and not require the cellular translational machinery means they might be useful in modifying entire cellular pathways without placing increased metabolic burden on producer cells. We report on the effect of constitutive depletion of miRNA-7 using decoy transcripts on the growth and productivity of CHO cells in fed-batch culture. Niall Baron, Ph.D., Senior Research Scientist, National Institute for Cellular Biotechnology, Dublin City University, Ireland 10:45 CASE STUDY • UNPUBLISHED DATA Technology Toolbox for Cell Line Development – Towards High Speed, Yield and Clonal Stability State of the art CHO platforms allow generation of high yielding production cell lines with short cycle times. Our strategy for further optimizing speed and yield of our CHO platform combines internal efforts with systematical screening and evaluation of external know-how. By integrating internal and external technologies we are aiming for further reducing cycle times and screening efforts of cell line development. Some novel vector technologies that we have evaluated to improve our platform towards high yielding fast processes, including a new selection marker and a targeted integration technology, will be presented. Thomas Jostock, Ph.D., Novartis Leading Scientist, Novartis Pharma AG, Switzerland 11:15 Technology Workshop Opportunity For more information, please contact Jennifer Thebodo at 508-614-1672 or jthebodo@ibcusa.com 11:45 Lunch on Your Own New to the Field Consider Attending IBC’s Two-Day Intensive Training Course: Cell Culture and Fermentation Bioprocessing (separate registration required) East and West Coast Locations: May 14-15, 2013 in San Diego, CA •June 12-13, 2013 in Cambridge, MA Full course details available at www.IBCLifeSciences.com/Courses 6 Register Early for Best Savings • www.IBCLifeSciences.com/CellLine • 800-390-4078
12:55 Chairman’s Remarks Lisa J. Graham, Ph.D., P.E., Senior Vice President, Bend Research Inc. Developing Cell Lines for Biosimilars 1:00 Glycoexpress: A Toolbox of Human Cell Lines for the Production of Glycooptimized Biotherapeutics Glycosylation is the major post-translational modification of biotherapeutics that depends on the cell line used for production. By establishment of the GlycoExpress toolbox we have generated a set of glycoengineered human cell lines for the high yield production of fully human glycoproteins. Currently, five different cell lines are established which allow the production of glycoproteins with different glycosylation features. Steffen Goletz, Ph.D., Chief Executive Officer, Chief Scientific Officer, Glycotope GmbH, Germany 1:30 UNPUBLISHED DATA Challenges in Cell Line and Process Development for NBEs and Biosimilars In developing NBEs and biobetters, speed, titer and an excellent product quality are all key elements, while for biosimilars, matching the originator product quality is the essential target. Here, we show how the use of our integrated BI-HEX platform which is based on well characterized cell lines and thorough understanding of USP and DSP processes is used to achieve fast and reliable development of high-titer cell lines and manufacturing processes, and how understanding of the process can be used to influence product quality attributes to successfully meet the target. Till Wenger, Ph.D., Associate Director, Cell Biology, Cell Culture II, Process Science, Boehringer Ingelheim, Germany 2:00 2nd Generation Sequencing for Cell Line Characterization during Biosimilar Development Biosimilar cell line development is a multi-step process, based on quality by design principles to generate a cell line producing a recombinant protein as similar to the originator’s protein as possible. Essential part of cell line development is genetic characterization. In addition to standard techniques, 2nd generation sequencing technologies enable deeper look into the parts of genome and transcriptome interesting for cell line developers. Dominik Gaser, Ph.D., Senior Scientist, Cell & Molecular Biology, Sandoz Biopharmaceuticals, Slovenia 2:30 Networking Refreshment Break Implementation of Analytical Tools and Strategies to Help Improve Clone Selection, Process Monitoring, Understanding and Development 3:00 UNPUBLISHED DATA High Throughput Imaging During Cell Line Development to Increase the Assurance of Clonality We are developing a fluorescent high throughput automated imaging protocol that can provide direct evidence on whether the cell line originated from one cell during the cloning step. To accommodate the throughput of the cell line development workflow at Genentech, fluorescent cell staining and automated fluorescent cell counting are used to reduce the need to manually inspect brightfield images. Since image data is acquired to track clone growth for all clones during the single-cell cloning process, confluence data or other electronic data can be used to drive automated hit-picking from the 384-well plates thus increasing efficiency and reducing ergonomic stress. We discuss the challenges and solutions implemented during the development of this protocol. David Shaw, Ph.D., Scientist, Early Stage Cell Culture, Genentech, Inc. 3:30 CASE STUDY • UNPUBLISHED DATA Data Integration Methodology that Leverages Coupled Bioreactor Analytics, Automated Sampling, and Applied Mathematics to Redefine Bioreactor Operation; Case Study Example Illustrating Impact on Cell Culture Productivity Process analytics can provide key links between process operation and product quality by enabling better data to strategically meet dynamic nutrient requirements of cell cultures. Individual analytics tools can also be coupled using the right data integration and applied mathematics techniques to provide “real time” guidance for process design and operation. Examples are shown, including a case study linking dielectric spectroscopy frequency spectra with the onset of apoptosis, which can then be linked to changes in cell performance and productivity. Lisa J. Graham, Ph.D., P.E., Senior Vice President, Bend Research Inc. Wednesday, May 22, 2013 (continued) 4:00 CASE STUDY • UNPUBLISHED DATA LC-MS/MS and Data Searching Strategies for Sequence Variance Detection Mass spectrometry provides a powerful tool for detecting low-abundance sequence variants within monoclonal antibodies. However, it is challenging to perform data analysis in a highly efficient and error-free manor. The use of currently available LC-MS instruments with high levels of sensitivity, precision and accuracy in combination with proteomic and statistical software allow for semi automation of data analysis for sequence variant analysis. Hangtian Song, Ph.D., Research Investigator I, Global Manufacturing and Supply, Bristol-Myers Squibb Co. 4:30 Scale-Down Automated Purification and Protein Analytics to Facilitate Cell Line Screening/PQ Analysis Abstract not available at time of print. Please visit www.IBCLifeSciences.com/CellLine for updates. Ling Santora, Ph.D., Senior Scientist III, AbbVie 5:00 Close of Conference 3EASY WAYS TO REGISTER: Industry Fees By March 1, 2013 By March 29, 2013 By April 26, 2013 Standard Rate After April 26, 2013 Main Conference Plus Dinner Symposium (Tues PM) $2299 $2399 $2499 $2699 Main Conference Only $1899 $1999 $2099 $2299 Academic/Govt. Fees* By March 1, 2013 By March 29, Standard Rate 2013 By April 26, 2013 After April 26, 2013 Main Conference Plus Dinner Symposium (Tues PM) $1599 $1699 $1799 $1999 Main Conference Only $1199 $1299 $1399 $1599 Present a Poster to Enhance Your Conference Experience All poster presenters must be registered conference attendees. The fee to present a poster in addition to your conference registration is: Vendors/Supplier*: $300 Pharma/Biotech: $100 Academic/Government: FREE * Vendor rate is for exhibiting/sponsoring companies and/or posters that upon review are of commercial/product focus Venue and Accommodations Hyatt Regency La Jolla 3777 La Jolla Village Drive, San Diego, CA Priority Code: B13189PDFWDL CALL 800.390.4078 or EMAIL +1.941.554.3500 @ reg@ibcusa.com WEB www.IBCLifeSciences.com/CellLine Special Conference Rate $229 Per Night Plus Tax Tel: 858-552-1234 • Central Reservations: 402-592-6464 or 1-888-421-1442 www.lajolla.hyatt.com Please call the hotel directly at the numbers above before April 19, 2013 to be included in IBC’s dedicated room block for this conference. Please identify yourself as a participant in IBC’s Cell Line Development and Engineering conference to receive the reduced room rate. Be sure to make you reservations as soon as possible as rooms tend to fill up very quickly and all reservations are subject to availability. Additional Registration Information For onsite registrations, please add $100. Program content and speakers subject to change. Conference badges are non-transferable and lost badges will not be replaced without payment of the full conference registration fee. Please note that payment is required in advance of the conference. Please make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC Life Sciences and attach to the registration form. Confirmation of your booking will be sent. Should you elect to pay by MasterCard, Visa or American Express, please send your credit card number, expiration date, name as it appears on card and signature along with the registration form. Registration Substitutions/Cancellations: If you need to make any changes or have any questions, please feel free to contact IBC’s customer service team via email at reg@ibcusa.com. Cancellations must be in writing and must be received by IBC prior to 10 business days before the start of the event. Upon receipt of a timely cancellation notice, IBC will issue a credit voucher for the full amount of your payment, which may be applied towards registration fees at any future IBC event held within 6 months after issuance (the “Expiration Date”). All credit vouchers shall automatically expire on the Expiration Date and shall thereupon become void. In lieu of issuance of a credit voucher, at your request, IBC will issue a refund less a $595 processing fee per registration. Registrants are advised that no credit vouchers or refunds will be issued for cancellations received 10 business days or less prior to start of the event, including cancellations due to weather or other causes beyond the Registrant’s control. IBC therefore recommends that registrants allow for unexpected delays in making travel plans. Substitutions are welcome at any time. If for any reason IBC decides to cancel this conference, IBC accepts no responsibility for covering airfare, hotel or other costs incurred by registrants, including attendees, sponsors, speakers and guests. SPECIAL NEEDS: If you have a disability or special dietary needs, please let us know in order that we may address your special needs for your attendance at this show. Please send your special needs via email to custserv@ibcusa.com. For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 7
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