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Overview
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Tuesday, October 18
8:30 Morning Coffee
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9:00 Comments
by Session Chairperson
Dr. Stephen Chambers, Vertex Pharmaceuticals Inc. |
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9:10 High-Throughput Optimization of Media
and Feeds for Mammalian Cell Culture
Dr. Geoffrey Hodge, VP Process Development and Technology, Xcellerex, LLC
A shaker plate model system, along with a statistical design of experiments,
has been used to optimize the base medium, feed formulation and feed delivery
strategy for a monoclonal antibody expressed in CHO cells. This approach allows
hundreds of individual medium or feed formulations to be tested in a single
experimental set-up. The challenges of developing and operating the model system
and results of the study will be presented.
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9:40
Optimization of E. coli Culture for Plasmid DNA Production
Mr. Aaron Carnes, Director of Process Development, Nature Technology Corporation
As gene therapy and DNA vaccines advance to FDA approval, it is essential to
devise industrial processes whereby plasmid DNA can be economically
manufactured. To date, optimal plasmid fermentation media and processes
result in yields of 100-200 mg plasmid DNA/liter. In order to address this
yield-limiting upstream step, we developed specialized media and
identified novel control parameters that increase specific plasmid yield
five to ten fold while maintaining high quality of the plasmid product.
Plasmid yields exceeding 1000 mg/liter have been obtained with resulting
fed-batch processes. Current research in our laboratory aims to shorten
cultivation time while preserving these very high plasmid yields. |
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10:10
Functional Proteomic Workcell For High Volume Plasmid Preparations for
Repeated In Vitro Protein Expression and High Throughput Screening to
Identify Mutant Enyzmes for Use at Low pH
Dr. Stephen Hughes, USDA
The possibility of examining the activity of enzymes at low pH has been
explored using a plasmid-based functional proteomic robotic workcell. A
novel mutagenesis paradigm was designed to alter the last four codons in
CelF from the anaerobic fungus Orpinomyces PC-2, which code for the four
amino acids at the amino end of the CelF enzyme. Plasmid DNA containing
the mutagenized inserts can be produced in sufficient quantity for
repeated in vitro transcription/translation in 96-well microplate-based
expression reactions to measure activity of the mutant enzymes at low pH
without need of in vivo expression systems. Screening for enhanced
activity of the mutants is accomplished by spotting on an
azo-carboxymethylcellulose plate. |
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11:10 From
Screen to Scale-Up: Rapid Development of an Optimized Media Formulation
Dr. James Brooks, Senior R&D Program Manager, BD Diagnostics -
Diagnostic Systems.
Having the appropriate optimized media formulation for a specific cell line
can significantly improve growth and protein production. Although many
benefits can be reaped from a media optimization process, the temporal and
financial investments required have precluded extensive utilization. We
have combined unique statistical approaches for the optimization of media
components and hydrolysate supplementation. This rapid procedure, in which
a chemically defined base medium is created, then supplemented with the
appropriate hydrolysate(s) to enhance cell performance and protein
production, allows the transition from media component
screening/optimization to bioreactor culture in less than nine months.
Thus, this approach enables the development of an optimal media
formulation to increase cell performance while decreasing the once lengthy
media development process. |
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11:40
Application of SimCell™ MicroBioreactors for Rapid, Scalable Upstream
Process Development
Dr. Stephen K. Tingley, Vice President, BioProcessors Corp.
This presentation will highlight the design features and capability of
SimCell™ MicroBioreactor high-throughput upstream process development
product platform. Reference to case studies will highlight the ability of
the SimCell™ system to reproducibly emulate bench top bioreactor process
development data and hence scalability. By reducing PD resource asset
requirements, increasing project capacity and speed to clinic the
conclusion will be presented that SimCell™ is an economically viable
solution to the process development data gap and will generate a positive
ROI. |
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12:00 Near Real-Time Monitoring of
Glycosylation
Dr. Johanna Allston Griffin, President, Procognia Inc.
Using a lectin array-based technology, it is possible to monitor
glycosylation of 20 unpurified samples of the same protein in parallel with a
reference standard. Data are obtained in less than four hours, enabling
selection and optimization of growth conditions of clones with the desired
glycosylation. Sub-micromolar quantities of protein can be assayed starting
early in fermentation to guide conditions for optimal glycosylation.
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| 12:30 Close of Conference |
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For
exhibit and sponsorship information, please contact:
Suzanne Carrol, Manager of Business Development
Phone: 781-972-5452 • E-mail: scarroll@healthtech.com
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