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June 12-13, 2013
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Cell Line Development & Engineering
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Agenda
7:00
Registration and Coffee
8:00
Chairwoman's Opening Remarks - The Legal, Regulatory and Technical Landscape
Cynthia Hoy, Ph.D., Process Science Fellow, PD Direct® Services, Life Technologies
Cynthia Hoy, Ph.D., Process Science Fellow, PD Direct® Services, Life Technologies
Keynote Addresses
8:15
Case
Study
Study
Coordinated Oscillations in Cortical Actin and Ca(2+) Correlate with Cycles of Vesicle SecretionThe 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
Unpublished Data
8:45
Case
Study
Study
Higher-Faster-Further: Why It Makes Sense to Invest in Innovation to Achieve Disruptive Improvements - A Case Study About 2nd Generation Media DevelopmentThe 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
Unpublished Data
10:15
Cell Line Development for Novel Molecules - Perspectives from the Interface of Discovery and Development
Abstract not available at time of print.
Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie
Abstract not available at time of print.
Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie
Unpublished Data
10:45
Case
Study
Molecular Assessment (MA) Programs - Balancing Upstream Work with Downstream PayoffsStudy
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.
Unpublished Data
11:15
Case
Study
Surviving the Valley of Death - Pre-Cell Line Generation Strategies to Reduce Attrition in Later Stages of Biopharmaceutical DevelopmentStudy
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
Technology Workshop
11:45
Protein titer and final product quality can be a trade-off, whereby titer is sacrificed in order to get desirable quality profiles. By integrating novel cell line development and media products, high producing cell lines that yield protein products with desired quality attributes can be achieved. The integration of these tools is also key to shortening timelines and removing bottlenecks.
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.
Kevin McCarthy, Ph.D., Group Leader for Cell Sciences, EMD Serono Inc.
Application, Integration and Characterization of 'Omics in Cell Line Development
Unpublished Data
1:30
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.
Vaibhav Jadhav, Researcher, Department of Biotechnology, University of Natural Resources and Life Sciences Vienna, Austria
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.
Vaibhav Jadhav, Researcher, Department of Biotechnology, University of Natural Resources and Life Sciences Vienna, Austria
Unpublished Data
2:00
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
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
Unpublished Data
2:30
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
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
Unpublished Data
3:00
Case
Study
Proteomic Analysis of Chinese Hamster Ovary (CHO) CellsStudy
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
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
Unpublished Data
4:30
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
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
Unpublished Data
5:00
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
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
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.
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 LearnedStudy
Abstract not available at time of print.
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
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
Unpublished Data
9:15
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
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
Unpublished Data
10:15
Case
Study
Impact of Media Components and Process Parameters on Product ColorStudy
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.
Unpublished Data
10:45
Case
Study
Viability and Productivity Improvement on Mammalian Fed Batch CultureStudy
Abstract not available at time of print.
Wenge Wang, Ph.D., Senior Principal Scientist, Bioprocess Research and Development, Pfizer Inc.
Technology Workshop
11:15
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
12:55
Chairman's Remarks
Andy Lin, Ph.D., Process Research & Development, Genentech, Inc.
Andy Lin, Ph.D., Process Research & Development, Genentech, Inc.
Approaches to Improve Cell Line Development Efficiencies, Resources and Timelines - What is the Impact?
Unpublished Data
1:00
Case
Study
Strategies to Fast/Lean POC and Risk MitigationStudy
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 <3L of culture volume. Using a simple selection protocol, stable clones can be made from MaxCyte transfected CHO cells in 6 weeks which generate antibody titers >1g/L.
James Brady, Ph.D., MBA, Director of Technical Applications, MaxCyte
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 <3L of culture volume. Using a simple selection protocol, stable clones can be made from MaxCyte transfected CHO cells in 6 weeks which generate antibody titers >1g/L.
James Brady, Ph.D., MBA, Director of Technical Applications, MaxCyte
Unpublished Data
2:00
Case
Study
Accelerating Cell Line Screening and Selection Using a Multiplexed 24 Well Microbioreactor and Streamlined PurificationStudy
Abstract not available at time of print.
Jessica Wuu, Ph.D., M.S., Senior Scientist, Process Sciences, Abbott Laboratories
Unpublished Data
2:30
Case
Study
Faster Upstream Development for Therapeutic Proteins: The Contribution of the GS-KO Host Cell LineStudy
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
Tribute to the Legacy of Marty Sinacore -
Reflections and State-of-the-Art Advances
3:30
Chairman's Remarks
Scott Estes, Ph.D., Director, Cell Culture Development, Biogen Idec
Scott Estes, Ph.D., Director, Cell Culture Development, Biogen Idec
3:45
A Tribute to Marty SinacoreMarty 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
Unpublished Data
4:30
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
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
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
Unpublished Data
5:30
Case
Study
Preservation of a Balanced Cell Culture Environment for Fed-Batch ProcessesStudy
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.
Dinner Symposium (Special registration required)
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:
6:00
What Is the State-of-the-Art in Expression? Are We Hitting Our Limits?
Moderators:
Cynthia Hoy, Ph.D., Process Science Fellow, PD Direct® Services, Life Technologies
Andrew Racher, Ph.D., Head of Process Development Sciences, Lonza Biologics plc, United Kingdom
Moderators:
Cynthia Hoy, Ph.D., Process Science Fellow, PD Direct® Services, 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
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
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
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
Moderators:
Luhong He, Ph.D., Senior Research Scientist, Eli Lilly and Company
Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie
7:00
Dinner
8:00
Dessert and summaries from each discussion
9:00
Close of Dinner Symposium
7:30
Coffee
8:00
Chairman's Remarks and Announcement of Poster Winners
Kevin J. Kayser, Ph.D., Director, Cell Sciences and Development, SAFC
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
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
Unpublished Data
8:45
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
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
Talk Title to Be Announced
Presenter to be Announced
Presenter to be Announced
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 CultureMicroRNAs 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
Unpublished Data
10:45
Case
Study
Study
Technology Toolbox for Cell Line Development - Towards High Speed, Yield and Clonal StabilityState 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
Technology Workshop
11:15
The development of scalable processes for cell lines is often challenging and is influences by many process parameters. Multiple rounds of experimental studies typically required to optimize process scale-up conditions to maximize the performance and productivity of a lead clone thereby lengthening timelines significantly. This presentation will explore media and technology platform approaches aimed at simplifying and accelerating the timeline from clone to manufacturing.
Peggy Lio, Ph.D., Director, Process Science & Cell Culture, GE Healthcare
11:45
Lunch on Your Own
12:55
Chairman's Remarks
Lisa J. Graham, Ph.D., P.E., Senior Vice President, Bend Research Inc.
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.
Lars Stöckl, Ph.D., Associate Director, Glycotope GmbH, Germany
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.
Lars Stöckl, Ph.D., Associate Director, Glycotope GmbH, Germany
Unpublished Data
1:30
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
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
Networking Refreshment Break
Implementation of Analytical Tools and Strategies to Help Improve Clone Selection, Process Monitoring, Understanding and Development
Unpublished Data
2:30
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.
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.
Unpublished Data
3:00
Case
Study
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 ProductivityStudy
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.
Unpublished Data
3:30
Case
Study
LC-MS/MS and Data Searching Strategies for Sequence Variance DetectionStudy
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.
4:00
Scale-Down Automated Purification and Protein Analytics to Facilitate Cell Line Screening/PQ Analysis
Abstract not available at time of print.
Ling Santora, Ph.D., Senior Scientist III, AbbVie
Abstract not available at time of print.
Ling Santora, Ph.D., Senior Scientist III, AbbVie
4:30
Close of Conference
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