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Cell Line Development & Engineering
CSS
Agenda
7:00
Registration and Networking Coffee
8:00
Chairperson's Opening Remarks
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research - Biotechnology Center of Excellence, Janssen Research and Development, LLC
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research - Biotechnology Center of Excellence, Janssen Research and Development, LLC
Advances in Screening & Automation for Clone Selection
New, Unpublished Data
8:15
Case
Study
Case Studies in Implementing Automation for Cell Line Development: High-Throughput Cloning and Fed Batch Screening of CHO Production Cell Lines for Therapeutic ProteinsStudy
Abstract not available at time of print.
Pamela Hawley-Nelson, Ph.D., Associate Director, Process Cell Culture, MedImmune
New, Unpublished Data
8:45
Implementing an Islands of Automation Approach to Cell Line Development: The Payback
Lonza introduced cell culture automation into its cell line selection and development programmes only where automation gives a clear benefit, the 'Islands approach'. Cell cloning, expansion of cultures into suspension culture, and initial screening stages now use automation. This allowed re-design of the whole process. Key benefits are shorter timelines and selection of cell lines showing potentially better fit to the GMP production process. The impact of process re-design will be discussed.
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics plc, United Kingdom
Lonza introduced cell culture automation into its cell line selection and development programmes only where automation gives a clear benefit, the 'Islands approach'. Cell cloning, expansion of cultures into suspension culture, and initial screening stages now use automation. This allowed re-design of the whole process. Key benefits are shorter timelines and selection of cell lines showing potentially better fit to the GMP production process. The impact of process re-design will be discussed.
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics plc, United Kingdom
New, Unpublished Data
9:15
Case
Study
Using the AmbrTM System as a Clone Screening ToolStudy
AmbrTM is an automated workstation that provides individual monitoring and control of culture DO and pH in single-use, stirred-tank bioreactors at a working volume of 10-15 mL. This talk reviews our evaluation of the system's ability to mimic bench-top bioreactors and its application in clone screening.
Wendy Hsu, M.S., Engineer II, Early Stage Cell Culture, Genentech, Inc.
9:45
Networking Refreshment Break in the Exhibit/Poster Hall
Working Closer with Drug Discovery and Research to Improve Process Development
10:30
Strategies to Create Effective Interfaces Between Discovery and Development
Biopharmaceutical programs require greater collaboration between discovery and development to generate the substantial preclinical data packages necessary for success in today's competitive environment. This talk will elaborate on early development strategies to de-risk programs, improve decision processes and ensure seamless transitions into development.
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research - Biotechnology Center of Excellence, Janssen Research & Development, LLC
Biopharmaceutical programs require greater collaboration between discovery and development to generate the substantial preclinical data packages necessary for success in today's competitive environment. This talk will elaborate on early development strategies to de-risk programs, improve decision processes and ensure seamless transitions into development.
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research - Biotechnology Center of Excellence, Janssen Research & Development, LLC
11:00
Streamlining the Discovery to Development Transition
The transition from discovery to development is an important step in the progression of therapeutic candidates from concept to clinical testing. this transition can be particularly challenging when working with diverse discovery organizations, external partners, and therapeutic modalities. this presentation will focus on the strategies we have implemented to address these challenges and ease the discovery to development transition.
Martin Allen, Ph.D., Senior Principal Scientist, Cell Line Development, Pfizer
The transition from discovery to development is an important step in the progression of therapeutic candidates from concept to clinical testing. this transition can be particularly challenging when working with diverse discovery organizations, external partners, and therapeutic modalities. this presentation will focus on the strategies we have implemented to address these challenges and ease the discovery to development transition.
Martin Allen, Ph.D., Senior Principal Scientist, Cell Line Development, Pfizer
New, Unpublished Data
11:30
Case
Study
Data Warehousing and Automated Visualization Based on an Ongoing Collaboration between Discovery And Process DevelopmentStudy
Managing data from multiple source systems is a major challenge for many labs, often requiring time-consuming manual transcription, analysis, and sample tracking. In this presentation we describe the application of an automated data warehousing system to cell line development. This system extracts, aggregates, analyzes, and graphs data, resulting in streamlined workflow and seamless sharing of data between discovery and process development.
Dawn Ellis, Research Scientist, Biologics Research - Biotechnology Center of Excellence, Janssen Research and Development, LLC
Technology Workshop
12:00
Small scale upstream technologies that are scalable are allowing organizations to select robust cell lines and develop processes earlier. The Micro-24 microbioreactor is one valuable scale-up tool for both microbial and mammalian applications. Data will be shown illustrating the advantages of controlled "high-throughput" bioreactors that allow rapid, very early stage development to decrease timelines as well as support QbD initiatives.
Tiffany D. Rau, Ph.D., Global Technical and Technology Manager, Pall Corporation
12:30
Luncheon in the Exhibit/Poster Hall
1:45
Chairperson's Remarks
Gene W. Lee, Ph.D., Director, Protein & Cell Sciences, EMD Serono Research Institute
Gene W. Lee, Ph.D., Director, Protein & Cell Sciences, EMD Serono Research Institute
Cell Line Generation and Cell Engineering for Novel Molecules - Non-Antibody and Non-Platform Proteins
New, Unpublished Data
2:00
CHO Cell Line Development for Dual Variable Domain Immunoglobulin (DVD-Ig™) Molecules
Abstract not available at time of print.
Stephanie Rieder, Ph.D., Senior Scientist, Biologics Department, Abbott Laboratories
Abstract not available at time of print.
Stephanie Rieder, Ph.D., Senior Scientist, Biologics Department, Abbott Laboratories
New, Unpublished Data
2:30
Cell Line Generation, Manufacturing, Release and Characterization of Recombinant Antibody Mixtures
Symphogen A/S has developed an expression platform, Sympress™, for cost-efficient and robust manufacturing of antibody mixtures. The cell banking strategy, manufacturing approach and strategies for the release and characterization will be addressed and compared to individual manufacturing approaches. Furthermore, a comparison in terms of development timelines, preclinical developmental costs, and manufacturing COGS between the two manufacturing approaches will be made in the presentation.
Søren K. Rasmussen, Ph.D., Principal Scientist, Symphogen A/S, Denmark
Symphogen A/S has developed an expression platform, Sympress™, for cost-efficient and robust manufacturing of antibody mixtures. The cell banking strategy, manufacturing approach and strategies for the release and characterization will be addressed and compared to individual manufacturing approaches. Furthermore, a comparison in terms of development timelines, preclinical developmental costs, and manufacturing COGS between the two manufacturing approaches will be made in the presentation.
Søren K. Rasmussen, Ph.D., Principal Scientist, Symphogen A/S, Denmark
New, Unpublished Data
3:00
Case
Study
High Yielding Vero Cell Line Characterization for Live Attenuated RSV Vaccine Process Development InitiativesStudy
Limitations of current vaccine production technologies coupled with emerging diseases demand new vaccine production substrates. While recent scientific and technological advances have made a number of new cell lines and primary cells available for vaccine production in research laboratories, systematic analysis and thorough characterization of these cell substrates for tumorigenicity and oncogenicity potential is still lacking. In this presentation, the development of a high-yielding clonal Vero cell line for production of a live attenuated RSV vaccine, and the new approaches taken to support its characterization are discussed. Using TaqMan low density array (TLDA) based apoptosis and metastasis gene expression finger printing, the Vero cell line was shown to be unique in gene expression profile and capable of supporting increased virus yield. We have developed a molecular and biochemical toolbox that can be used to facilitate live attenuated RSV vaccine process development and manufacturing.
Althaf Hussain, Ph.D., Principal Scientist, MedImmune
3:30
Networking Refreshment Break in the Exhibit/Poster Hall
Afternoon Keynote Presentations
New, Unpublished Data
4:00
Putting the CHO Genome to Work: Illustrations to Increase Transgene Integration and Expression and to Improve Protein ProcessingIncorporation of epigenetic regulatory DNA elements in expression vectors can prevent gene silencing and increase transcription rates. This has yielded stable and very high protein expression from CHO cells and increased therapeutic production in the bioreactor. Such progress have led to new currently emerging bottlenecks encompassing transgene genomic integration, protein secretion and processing, and cell physiology. We have determined the genome sequence of CHO cells used for pharmaceutical production and of derived producer clones. This allows cell engineering for increased genomic transgene integration by homologous recombination and for improved protein secretion and modifications. This presentation will illustrate how a systematic and multi-level approach can be used to improve the expression of pharmaceutical proteins.
Nicolas Mermod, Ph.D., Professor, Director, Institute of Biotechnology, University of Lausanne, Switzerland
4:45
A Look Back and a Look Ahead: Perspectives from Cell Line Development at a Large Biotechnology and Now Pharma CompanyIn this talk I will examine past cell line development practices and how they have evolved to the picture we have today. I will discuss what I would do differently knowing what we know now. I will paint a picture of where I see the field of cell line development heading over the next few years.
John C. Joly, Ph.D., Senior Director of Early Stage Cell Culture, Process Development, Genentech, Inc.
5:30
Cocktail Reception in the Exhibit/Poster Hall
Co-Sponsored by
Co-Sponsored by
7:30
Networking Coffee
8:00
Chairperson's Opening Remarks
Andrew Snowden Ph.D., Principal Scientist, Cell Science and Technology, Amgen Inc.
Andrew Snowden Ph.D., Principal Scientist, Cell Science and Technology, Amgen Inc.
Improving Predictability in Early Development and Analytical Tools for Cell Lines and Product Quality Checks
New, Unpublished Data
8:15
Case
Study
Aberrant mRNA Splicing and Mitigation Strategy for Cell Line GenerationStudy
Aberrant splicing of recombinant genes was encountered when they were expressed in CHO cells, which resulted in poor productivity or unacceptable levels of protein aggregation. Early evaluation during cell line generation is essential to ensure transcript integrity of recombinant genes. In this presentation, we will describe case studies and mitigation strategies to ensure cell lines are suitable for clinical applications.
Luhong He, Ph.D., Senior Research Scientist, Bioprocess R&D, Lilly Research Laboratories
New, Unpublished Data
8:45
Case
Study
High Throughput Fed-Batch Screening for Improved Cell Line SelectionStudy
This study focuses on the development of a fed-batch platform process in a shaking 96-deepwell plate system, which is used to screen hundreds of cell lines in suspension. The feeding system and the run duration are equivalent to Merck Serono's bioreactor platform process. We highlight some of the key process parameters that impact cell growth and culture viability in such a system.
Matthieu Stettler, Ph.D., Manager, Upstream Development, Biotech Process Sciences, Merck Serono S.A., Switzerland
Approaches to Develop Cell Lines for Biosimilars
9:15
An Analytical and Cell Culture Platform for the Development of a Biogeneric
Abstract not available at time of print.
Holly Prentice, Ph.D., Associate Director, Pharmaceutical Sciences, Momenta (invited)
Abstract not available at time of print.
Holly Prentice, Ph.D., Associate Director, Pharmaceutical Sciences, Momenta (invited)
New, Unpublished Data
9:45
Case
Study
Upstream Process Development for Biosimilar Monoclonal AntibodiesStudy
The biosimilar monoclonal antibody has been developed with fed-batch process. Since brand product was produced from perfusion process, it was evaluated if process change from perfusion to fed-batch gave impact on product quality and cell performance. In terms of cell performance, volumetric productivity was increased by four times and subsequently process performance was increased by 10 times in fed-batch culture due to over 10 times higher scalability. In terms of glycosylation pattern and charge variants, there was no impact on product quality by process change but intact IgG level was slightly decreased in fed-batch mode. Especially, different feeding medium showed different glycosylation patterns. Furthermore, there was no impact on biological activity including TNF alpha, Fcgamma and C1q binding affinity.
SooYoung Lee, Ph.D., Senior Manager, R&D Division, Celltrion Inc., South Korea
10:15
Networking Refreshment Break in the Exhibit/Poster Hall
Interactive Panel Discussion
10:45
Sponsored by
Improving Product Manufacturability: Discovery Through DevelopmentReducing timelines and effort for drug development includes many challenges. Focusing on early prediction of manufacturability, speed in cell line construction and integration of cell culture and purification process development can provide robust processes that deliver commercial quantities of biologically active product.
This panel of industry experts will lead discussions on novel technologies relating to:
- Early Prediction of Manufacturability
- Cell line Construction using Lonza's GS Knock-Out Host Cell Line
- Integration of Upstream and Downstream Process Development
Andy Racher, Senior Principal Scientist, Cell Culture Process Development, Lonza
Panelists:
To be determined
Technology Workshop
12:00
Peggy Lio, Ph.D., Senior Process Science Fellow, Bioproduction, Life Technologies
12:30
Luncheon in Exhibit/Poster Hall
1:45
Chairperson's 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.
Improving Process and Product Quality
New, Unpublished Data
2:00
Control of Glycosylation in Animal Cell Bioprocesses
The function and activity of a biopharmaceutical is highly dependent upon its glycosylation profile. It is important to be able to control both upstream and downstream processing to maximize the desired glycosylation during cell culture and to subsequently minimize any selective loss during downstream processing. The presentation will explore those critical parameters of a bioprocess that affect protein glycosylation.
Michael Butler, Ph.D., Professor, Microbiology, University of Manitoba
The function and activity of a biopharmaceutical is highly dependent upon its glycosylation profile. It is important to be able to control both upstream and downstream processing to maximize the desired glycosylation during cell culture and to subsequently minimize any selective loss during downstream processing. The presentation will explore those critical parameters of a bioprocess that affect protein glycosylation.
Michael Butler, Ph.D., Professor, Microbiology, University of Manitoba
New, Unpublished Data
2:30
Case
Study
A Novel Method for Controlling N-Linked Glycosylation and Improving Biological Activity of a Therapeutic Fusion Protein Expressed in CHOStudy
Abstract not available at time of print.
Rodney Combs, M.A., Associate Research Fellow, Bioprocess Development, Pfizer Inc.
3:00
Networking Refreshment Break & Dedicated Poster Viewing
3:30
Case
Study
Clone Selection Based on Product Quality and QuantityStudy
Monitoring the characteristics of a biological product are essential during the development of an industrialized production process. In this case study, a ForteBio Octet binding assay and several other in vitro assays were implemented to efficiently screen for CHO clones that express a high amount of the product as well as the appropriate product quality attributes required for therapeutic efficacy.
Oren Beske, Ph.D., Vice President, Aragen Biosciences
New, Unpublished Data
4:00
Case
Study
Impact of High-Throughput Screening on Cell Line Development and Product QualityStudy
Currently, there is high focus on the ability to tailor product quality through cell line development and selection of the right clone. The increased availability of automated equipment both for clone handling and analysis enables comprehensive screenings in down-scale models. This presentation will describe Boehringer-Ingelheims year-long use of automated equipment and discuss our view on the emergence and usefulness of new and even smarter robotics.
Anne B. Tolstrup, Ph.D., Director, Cell Culture Process Science, Boehringer Ingelheim, Germany
New, Unpublished Data
4:30
Case
Study
Process Analytical Technologies that Enable Better Control and Monitoring the Process for Better Clone Selection and Process DevelopmentStudy
Novel sensor technologies have enabled instrumentation of previously unmonitored cell culture vessels and miniaturization of the traditional stirred tank bioreactor. By measuring pH and oxygen levels in commonly used disposables, far greater process information becomes available. Case studies of instrumented disposables and successful scale-up/down of cultures are presented, including a novel scale-down paradigm for the wave bioreactor. Collectively, these approaches lead to easier adoption of PAT in early stage cell culture.
Antonio R. Moreira, Ph.D., Vice Provost for Academic Affairs, University of Maryland Baltimore County
Back by Popular Demand!
5:00
Dinner Symposium
(Special Registration Required)
Please join us for this highly interactive 3 hour evening exchange in a roundtable format which will encourage participants to share their experiences and concerns amongst several discussion topics that include:
(Special Registration Required)
Please join us for this highly interactive 3 hour evening exchange in a roundtable format which will encourage participants to share their experiences and concerns amongst several discussion topics that include:
Controlling or Selecting Product Quality Attributes for Early Stage vs Late Stage Development and Considerations for Biosimilars
Moderators:
Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc.
SooYoung Lee, Ph.D., Senior Manager, R&D Division, Celltrion Inc., South Korea
Moderators:
Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc.
SooYoung Lee, Ph.D., Senior Manager, R&D Division, Celltrion Inc., South Korea
What's the Latest Strategies for Early Phase Development? Is it Fast and Lean or Geared Towards Commercialization?
Moderators:
Andrew Snowden Ph.D., Principal Scientist, Cell Science and Technology, Amgen Inc.
Stephanie Rieder, Ph.D., Senior Scientist, Biologics Department, Abbott Laboratories
Moderators:
Andrew Snowden Ph.D., Principal Scientist, Cell Science and Technology, Amgen Inc.
Stephanie Rieder, Ph.D., Senior Scientist, Biologics Department, Abbott Laboratories
How Well is Cell Line Development Aligned with Cell Culture Process Development?
Moderators:
Antonio R. Moreira, Ph.D., Vice Provost for Academic Affairs, University of Maryland Baltimore County
Matthieu Stettler, Ph.D., Manager, Upstream Development, Biotech Process Sciences, Merck Serono S.A., Switzerland
Moderators:
Antonio R. Moreira, Ph.D., Vice Provost for Academic Affairs, University of Maryland Baltimore County
Matthieu Stettler, Ph.D., Manager, Upstream Development, Biotech Process Sciences, Merck Serono S.A., Switzerland
Can Cell Line Development be Outsourced and, if so, What are the Tradeoffs?
Moderators:
Gene W. Lee, Ph.D., Director, Protein & Cell Sciences, EMD Serono Research Institute
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics plc, United Kingdom
Moderators:
Gene W. Lee, Ph.D., Director, Protein & Cell Sciences, EMD Serono Research Institute
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics plc, United Kingdom
Best Applications of -Omics Technology: Which 'Omics Tools Will Produce the Largest Benefits and Why?
Moderators:
Alan Dickson, Ph.D., Director of Centre of Excellence in Biopharmaceuticals, The University of Manchester, United Kingdom
Scott Tenenbaum, Ph.D., Acting CNSE Vice President for Research & Associate Head of Nanobioscience, College of Nanoscale Science and Engineering, University of Albany-SUNY
Moderators:
Alan Dickson, Ph.D., Director of Centre of Excellence in Biopharmaceuticals, The University of Manchester, United Kingdom
Scott Tenenbaum, Ph.D., Acting CNSE Vice President for Research & Associate Head of Nanobioscience, College of Nanoscale Science and Engineering, University of Albany-SUNY
Agenda:
5:00
Discussion Groups
6:00
Dinner
7:00
Summaries of key takeaways from each discussion presented
7:45
Open Q&A for Discussion Leaders
8:00
Close of Symposium
Site Tour to Boehringer Ingelheim's Fremont, CA Facility
5:00 pm – 9:00 pm
Boehringer Ingelheim Fremont is characterized by its exclusive architectural style featuring extensive use of glass throughout, providing visibility into production suites and symbolizing the unique way of open and transparent collaboration with our customers.
Boehringer Ingelheim invites you to get an insight in our 200,000 square feet state-of-the-art facilities which are ideally suited for the development and commercialization of our customer projects like proteins and antibodies for therapeutic use.
Space is limited and available on a first come, first served basis.
Pre-registration is required. No additional fee is required.
7:30
Networking Coffee
8:00
Chairperson's Remarks & Announcement of Poster Winners
Kevin Kayser, Ph.D., Associate Director Cell Sciences and Development, SAFC
Kevin Kayser, Ph.D., Associate Director Cell Sciences and Development, SAFC
Application of Genomic & Other 'Omics Tools, Novel Technologies and Next Generation Sequencing for Cell Line Development
New, Unpublished Data
8:15
Case
Study
Applying 'Omics Technologies Towards an Integrated Understanding of Bioprocess DevelopmentStudy
This presentation describes studies of metabolomic profiling of rCHO cells in batch culture, defining cellular events that characterize phases of culture and responsiveness to feeds. These exemplars will be used to illustrate how 'omics-led approaches are used to optimize bioprocessing (biomass, product formation, product quality) based on appropriate selection of different 'omics approaches and levels of integration of data sets.
Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals, The University of Manchester, United Kingdom
8:45
Predicting Cell Specific Productivity from CHO Gene Expression
We present the first predictive model of productivity in CHO bioprocess culture based on gene expression profiles. A supervised regression algorithm, partial least squares (PLS) incorporating jackknife gene selection, was utilized to produce a model of cell-specific productivity (Qp) capable of predicting Qp to within 4.44 pg/cell/day. Several of the genes constituting the model are linked with biological processes relevant to protein metabolism.
Colin Clarke, Ph.D., Postdoc, National Institute for Cellular Biotechnology, Dublin City University, Ireland
We present the first predictive model of productivity in CHO bioprocess culture based on gene expression profiles. A supervised regression algorithm, partial least squares (PLS) incorporating jackknife gene selection, was utilized to produce a model of cell-specific productivity (Qp) capable of predicting Qp to within 4.44 pg/cell/day. Several of the genes constituting the model are linked with biological processes relevant to protein metabolism.
Colin Clarke, Ph.D., Postdoc, National Institute for Cellular Biotechnology, Dublin City University, Ireland
New, Unpublished Data
9:15
Case
Study
Safety Testing of Engineered Cell Lines using Massive Parallel Sequencing TechnologyStudy
Adventitious agent testing of engineered cell lines in production is an important, regulated safety requirement. In the past two years, most agents that caused bioreactor failures were unknowns; that is, they were only 80% identical to genomes present in GenBank. Though not detected by traditional nucleic acids tests, they were fully characterized using massively parallel sequencing (MPS). MPS can be applied to multiple points during development and production, and represent a dramatic improvement in breadth of coverage and safety.
John Kolman, Ph.D., Senior Director, Global Genomic Services, BioReliance Corporation
9:45
Networking Refreshment Break
Featured Presentation
New, Unpublished Data
10:15
An Update on the International Community's Efforts at CHOgenome.orgMany biopharmaceuticals are produced in Chinese hamster ovary (CHO) cells. The CHO K1 cell line is an ancestor to many production cell lines and was recently sequenced. We will discuss the aspects of the international community's efforts at developing an infrastructure to support, host, and disseminate genome-scale data related to CHO cell lines.
Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Director of theDelaware Biotechnology Institute, University of Delaware
10:45
CHO Genome "Show and Tell" Workshop
This hands-on, interactive workshop will include live CHOgenome.org website demonstrations and case studies to help you -
Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Director of theDelaware Biotechnology Institute, University of Delaware
This hands-on, interactive workshop will include live CHOgenome.org website demonstrations and case studies to help you -
- Learn the next steps that should be taken
- See the web tools in action and show you how it works
- Get answers to your specific questions
- Receive expert guidance on using the web tools to fully utilize the genome-scale data
Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Director of theDelaware Biotechnology Institute, University of Delaware
11:45
Technology Workshop
IBC's technology workshops offer technology and service providers an opportunity to discuss practical applications of their technology during the conference. For more information about this sponsorship, please contact Jennifer Thebodo at 508-614-1672 or jthebodo@ibcusa.com.
IBC's technology workshops offer technology and service providers an opportunity to discuss practical applications of their technology during the conference. For more information about this sponsorship, please contact Jennifer Thebodo at 508-614-1672 or jthebodo@ibcusa.com.
12:15
Lunch on Your Own
1:45
Chairperson's Remarks
Mark Melville, Ph.D., Director, CLG & USP, PERCIVIA LLC
Mark Melville, Ph.D., Director, CLG & USP, PERCIVIA LLC
New Cell Line Generation and Engineering Strategies
2:00
Engineering GS Knockout CHO Cell Lines
The GS Gene Expression System™ is widely used for cGMP manufacturing of therapeutic proteins using mammalian cells. Currently, nine 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 through introduction of a GS-knockout version, CHOK1SV GS-KO, of its standard CHO host. This talk will describe 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
The GS Gene Expression System™ is widely used for cGMP manufacturing of therapeutic proteins using mammalian cells. Currently, nine 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 through introduction of a GS-knockout version, CHOK1SV GS-KO, of its standard CHO host. This talk will describe 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
2:30
Artificially Designed Promoters - Exploiting Nucleotide Composition to Engineer Novel Promoters
Using computational analyses, so far undetected sequence elements, underrepresented in the entire human genome, were discovered which per se are able to initiate transcription. Some of these artificial sequences exhibit promoter activities comparable to the SV40 promoter in different mammalian cell lines. The novel promoters show potential to be optimised to desired expression levels suitable for biotechnological applications.
Martina Baumann, Ph.D., Researcher, Department of Biotechnology, University of Natural Resources and Life Sciences, Austria
Using computational analyses, so far undetected sequence elements, underrepresented in the entire human genome, were discovered which per se are able to initiate transcription. Some of these artificial sequences exhibit promoter activities comparable to the SV40 promoter in different mammalian cell lines. The novel promoters show potential to be optimised to desired expression levels suitable for biotechnological applications.
Martina Baumann, Ph.D., Researcher, Department of Biotechnology, University of Natural Resources and Life Sciences, Austria
3:00
Networking Refreshment Break
New, Unpublished Data
3:30
Using RNA-Binding Proteins and microRNA Targeting to Study the Human Regulatory Code
Our data suggests that miRNA are modulating RNA-Binding binding sites in a dynamic manner. This model predicts that miRNAs indirectly or directly binding to RBP binding sites and multiple regulatory elements could simultaneously be influenced by miRNA-mRNA contacts. Consequently, binding of one or more miRNA could result in conformational changes in mRNA structure, thereby revealing or masking other regulatory elements.
Scott Tenenbaum, Ph.D., Acting CNSE Vice President for Research & Associate Head of Nanobioscience, College of Nanoscale Science and Engineering, University of Albany-SUNY
Our data suggests that miRNA are modulating RNA-Binding binding sites in a dynamic manner. This model predicts that miRNAs indirectly or directly binding to RBP binding sites and multiple regulatory elements could simultaneously be influenced by miRNA-mRNA contacts. Consequently, binding of one or more miRNA could result in conformational changes in mRNA structure, thereby revealing or masking other regulatory elements.
Scott Tenenbaum, Ph.D., Acting CNSE Vice President for Research & Associate Head of Nanobioscience, College of Nanoscale Science and Engineering, University of Albany-SUNY
New, Unpublished Data
4:00
Cell Line Development Strategies for Rapid and Efficient Production of Bispecific DART™ Molecules
Abstract not available at time of print.
Valentina C. Ciccarone, Ph.D., Principal Scientist, Cell Line Development, Macrogenics, Inc.
Abstract not available at time of print.
Valentina C. Ciccarone, Ph.D., Principal Scientist, Cell Line Development, Macrogenics, Inc.
New, Unpublished Data
4:30
Single Gene Copy CHO Production Lines Obtained by Targeted Integration
The key step to increased throughput in biotherapeutic development and speed to the clinic is the design of integrated processes for cell line generation and protein production that yield predictable bioreactor performance such that minimal process development is required. Targeted integration into a well-characterized locus provides the foundation for true platform performance. This platform approach reduces the development time from several months to several weeks and significantly increases cell line construction throughput.
Anke Watty, Ph.D., Senior Staff Scientist, Protein Expression Sciences, Regeneron Pharmaceuticals
The key step to increased throughput in biotherapeutic development and speed to the clinic is the design of integrated processes for cell line generation and protein production that yield predictable bioreactor performance such that minimal process development is required. Targeted integration into a well-characterized locus provides the foundation for true platform performance. This platform approach reduces the development time from several months to several weeks and significantly increases cell line construction throughput.
Anke Watty, Ph.D., Senior Staff Scientist, Protein Expression Sciences, Regeneron Pharmaceuticals
5:00
Close of Conference
Copyright IBC Life Sciences, a part of Informa Life Sciences Group. Phone: 800.390.4078 Email: reg@ibcusa.com