Cell Line Development & Engineering

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Monday, May 20, 2013 (continued) 3:00 CASE STUDY • UNPUBLISHED DATA Proteomic Analysis of Chinese Hamster Ovary (CHO) Cells To complement the recent genomic sequencing of Chinese hamster ovary (CHO) cells, proteomic analysis was performed on CHO cells including the cellular proteome, secretome, and glycoproteome using mass spectrometry and multiple strategies. A total of 6164 grouped proteins were identified. This first large-scale proteomic analysis enhances the knowledge base about CHO capabilities for recombinant expression and cell line engineering. Deniz Baycin Hizal, Ph.D., Chemical and Biomolecular Engineering, Johns Hopkins University 3:30 Networking Refreshment Break and Poster/Exhibit Viewing Proliferation and Integration of Data Sets 4:00 Integrated miRNA, mRNA and Protein Expression Analysis Reveals the Role of Post-Transcriptional Regulation in Controlling CHO Cell Growth Rate To investigate the role of microRNA (miRNA) in the regulation of Chinese hamster ovary (CHO) cell growth, qPCR, microarray and quantitative LC-MS/ MS analysis were utilised for simultaneous expression profiling of miRNA, mRNA and protein. In this presentation, the biological processes found to be correlated with CHO cell growth rate is discussed and the analysis of multiple datasets to identify potential miRNA-mediated regulation demonstrated. Colin Clarke, Ph.D., Postdoc, National Institute for Cellular Biotechnology, Dublin City University, Ireland 4:30 UNPUBLISHED DATA Using Metabolite Profiling Data to Make a Difference to CHO Cell Bioprocesses Metabolite profiling offers an ‘omics approach that enables a very immediate read-out of the status of CHO cells in culture. From an integrated analysis of profile changes, interpretations can be attained of metabolic phenotype associated with growth and/or recombinant protein production. This presentation illustrates our molecular understanding of relationships between feeding, cellular metabolism and desirable phenotype in CHO cells. Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals, Professor of Biotechnology, University of Manchester, United Kingdom 5:00 UNPUBLISHED DATA Genome-Scale Analysis of Chinese Hamster Ovarian Cell Lines Over the past 15 years, microbe-based engineering has advanced through three major innovations: 1) genome sequencing, 2) genome-scale metabolic models, and 3) tools for genome editing. These have allowed engineers to identify cellular parts, simulate product synthesis, and manipulate host genomes to enhance production. Similar advances are now upon us in the engineering of CHO cell lines for bioprocessing. Bernhard Palsson, Ph.D., Principal Investigator, Galletti Professor of Bioengineering, Adjunct Professor Medicine, University of California, San Diego 5:30 Cocktail Reception in Poster/Exhibit Hall Tuesday, May 21, 2013 7:30 Coffee 8:00 Chairman’s Opening Remarks Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc. Approaches to Improve Process and Product Quality 8:15 CASE STUDY Clonality – Challenges, Approaches and Lessons Learned Abstract not available at time of print. Please visit www.IBCLifeSciences.com/CellLine for updates. Pamela Hawley-Nelson, Ph.D., Associate Director, Process Cell Culture, MedImmune 8:45 Use of QPCR and DNA Sequencing Tools to Ensure Product Quality and Safety Quantitative PCR (Q-PCR) and DNA sequencing are tools that enable rapid, sensitive and precise quantitation, detection and identification of critical cellular and process impurities in cell culture manufacturing and product purification. Additionally, these tools can be utilized in development and characterization of production cell lines and in routine monitoring of cell line stability. In this presentation, the applications of these technologies and present data demonstrating the performance of assays for impurity assessment, cell line characterization, contaminant detection and identification are reviewed. Michael T. Brewer, Director, Head of Pharma Analytics, Life Technologies 9:15 UNPUBLISHED DATA High-Throughput Product Quality Assays for Cell Line and Process Development Here we present high-throughput (HTP) analytical assays to facilitate rapid product quality using 96-well plate formats. These HTP product quality assays include HTP protein quantitation followed by HTP protein purification and product quality analyses. With these HTP analytical product quality assays we can assess product quality in the early stage of clone screening, as well as expedite the cell line and process development. Shashi Prajapati, Ph.D., Senior Scientist, Cell Culture Development, High Throughput Analytical Group. Biogen Idec 9:45 Networking Refreshment Break and Poster/Exhibit Viewing 10:15 CASE STUDY • UNPUBLISHED DATA Impact of Media Components and Process Parameters on Product Color Health Authorities expect that companies monitor and control the color of liquid formulations of monoclonal antibodies. Cell culture conditions and media components were investigated and shown to influence color. Mechanisms that could explain these effects are discussed. Some process changes that reduced color also decreased titer, and strategies for reducing color which avoid productivity impact are discussed. Natarajan Vijayasankaran, Ph.D., Senior Engineer, Late Stage Cell Culture, Genentech, Inc. 10:45 CASE STUDY • UNPUBLISHED DATA Viability and Productivity Improvement on Mammalian Fed Batch Culture Abstract not available at time of print. Please visit www.IBCLifeSciences.com/CellLine for updates. Wenge Wang, Ph.D., Senior Principal Scientist, Bioprocess Research and Development, Pfizer Inc. 11:15 Technology Workshop A New Bench Scale Single-Use Bioreactor System Development of a new bench scale “rocker style” single use bioreactor will be described, with discussion of physical parameters for design space definition and performance measurement; with comparison to industry standard systems. Presentation will conclude with results from CHO batch culture trials for design validation, showing significant increases in achievable cell densities and cell productivity. Charles G. Golightly, Global Product Manager, Pall Life Sciences 11:45 Luncheon and Poster/Exhibit Viewing Send a group of 3 and the 4th goes FREE! It’s a fact – attendees walk away with the most value when they experience it with a peer – there is just too much information available for one person to capture it all. As a result, we are pleased to offer a 4th free registration when you register 3 people at the standard rate. For more information call our group sales advocate at 646-895-7445. 4 Register Early for Best Savings • www.IBCLifeSciences.com/CellLine • 800-390-4078
Tuesday, May 21, 2013 (continued) 12:55 Chairman’s Remarks Andy Lin, Ph.D., Process Research & Development, Genentech, Inc. Approaches to Improve Cell Line Development Efficiencies, Resources and Timelines – What is the Impact 1:00 CASE STUDY • UNPUBLISHED DATA Strategies to Fast/Lean POC and Risk Mitigation Fast/lean to PoC is highly desired for drug development. However, fast/lean cell line generation could potentially result in the identification of clonal cell lines that are only suitable for early-phase development and result in the need to change cell lines for commercial development, which can pose a significant challenge in demonstrating consistency of processes/products. In this presentation, we share recloning case studies as a potential mitigation strategy to the risks associated with fast/lean to PoC approaches. Luhong He, Ph.D., Senior Research Scientist, Eli Lilly and Company 1:30 Streamlining Antibody Development Using Large Scale, CHO Transient Gene Expression (TGE) Followed by Rapid Production of CHO Stable Pools Antibody production for early stage antibody development activities is commonly conducted using transiently transfected HEK cells to produce adequate quantities of antibody for characterization, while later stage screening and biomanufacturing rely on CHO-based stable cell lines. Migration from HEK to CHO cell backgrounds can lead to manufacturing challenges and changes in post translational modifications that can alter the antibody’s therapeutic potential. The time line of antibody development can be greatly streamlined using large scale transient gene expression (TGE) directly within CHO cells. CHOS cells can be transfected with >95% transfection efficiency and cell viability using MaxCyte flow electroporation. MaxCyte transiently transfected CHO cells produce antibody titers > 400 mg/L, enabling greater than 1 gram of protein from 1g/L. James Brady, Ph.D., MBA, Director of Technical Applications, MaxCyte 2:00 CASE STUDY • UNPUBLISHED DATA Accelerating Cell Line Screening and Selection Using a Multiplexed 24 Well Microbioreactor and Streamlined Purification Abstract not available at time of print. Please visit www.IBCLifeSciences.com/CellLine for updates. Jessica Wuu, Ph.D., M.S., Senior Scientist, Process Sciences, Abbott Laboratories 2:30 CASE STUDY • UNPUBLISHED DATA Faster Upstream Development for Therapeutic Proteins: The Contribution of the GS-KO Host Cell Line The GS Gene Expression System is widely used for cGMP manufacturing of therapeutic proteins using mammalian cells. Currently, thirteen licensed products are manufactured using the GS System. Although the system is well established, Lonza is continually improving the GS System. Recent improvements have focussed on a number of areas including reducing the time for cell line development. The latter was achieved partly through introduction of a GS-knockout version, CHOK1SV GS-KO, of its standard CHO host. This talk describes some of work to develop and characterise the new host cell line, along with comparative performance data from 10 L bioreactor cultures, and the benefits from switching to the new host. Andrew Racher, Ph.D., Head of Process Development Sciences, Lonza Biologics plc, United Kingdom 3:00 Networking Refreshment Break and Poster/Exhibit Viewing Premier Publication: Media Partners: Tribute to the Legacy of Marty Sinacore – Reflections and State-of-the-Art Advances 3:30 Chairman’s Remarks Sadettin S. Ozturk, Ph.D., Senior Director, Head of Process Development, MassBiologics 3:45 A Tribute to Marty Sinacore Marty Sinacore has been one of the contributors of developing today’s technology used for mammalian cell based production. Besides being a great scientist Marty has been the mentor of countless young scientists that now are part of the backbone of our community. In this presentation, Tim and Thomas highlight some of Marty’s work and how it influenced the way we do cell based manufacturing today. Tim Charlebois, Ph.D., Vice President, Technology & Innovation Strategy, Pfizer Inc. Thomas Ryll, Ph.D., Senior Director, Cell Culture Development, Biogen Idec 4:30 UNPUBLISHED DATA Development of a Custom Cell Line Toolbox with Diverse Product Quality Attributes Although the simplicity of having a single, well characterized host upon which to initiate cell line engineering has many advantages, a one size fits all approach does have its drawbacks. The range of product quality attributes achievable will be limited by the intrinsic phenotype of said host and may not overlap with the optimum profile for a given therapeutic. With the increased sophistication of engineering tools enabling precise genome editing or mRNA depletion, it’s now relatively straight forward to develop modified hosts with tailored made phenotypes. The end result being the cell line engineer can develop a “toolbox” of varied hosts that can be employed to insure that critical quality attributes or biosimilarity is achievable. Scott Estes, Ph.D., Director, Cell Culture Development, Biogen Idec 5:00 The Impact of ‘Omics Technologies on Process Development – The Promise and the Reality It was just over 10 years ago that the use of ‘omics technologies started to make their way into bioprocess development. For many early adopters of the technology, the promise was a better fundamental understanding of cell biology that would lead to engineered cell lines that would be optimized for production of secreted biotherapeutics. That isn’t what happened, however. Mark Melville, Ph.D., Senior Director, Bioprocess Development, Epirus Biopharmaceuticals 5:30 CASE STUDY • UNPUBLISHED DATA Preservation of a Balanced Cell Culture Environment for Fed-Batch Processes This presentation demonstrates with examples the effect of cell culture imbalance on cell growth and productivity, as well as specific solutions to remedy these issues. A simple solution to revive the drop in cell viability observed during the late stage of cell culture is also discussed. Finally, a systematic approach of medium feeding to achieve high cell density, high viability, and high titer process is also described. Yen-Tung Luan, M.S., Associate Research Fellow, Bioprocess R&D, Pfizer Inc. “By narrowly targeting the technologies used at the border of R&D of biotherapeutics, this event provides an intensive 3-day review of current, valuable information for this highly specialized group.” - Pam Hawley-Nelson, Ph.D., Associate Director, Process Cell Culture, MedImmune For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 5
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