Cell Line Development & Engineering
Cell Line Development & Engineering
Cell Line Development & Engineering
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6:00 Dinner Symposium (Special registration required) Tuesday, May 21, 2013 (continued)<br />
Please join us for this highly interactive 3 hour evening exchange in a roundtable format, which encourages participants to share their experiences<br />
and concerns amongst several discussion topics that include:<br />
What Is the State-of-the-Art in Expression<br />
Are We Hitting Our Limits<br />
Moderators:<br />
Laurie Donahue-Hjelle, Ph.D., Director, New Product <strong>Development</strong>,<br />
Life Technologies<br />
Andrew Racher, Ph.D., Head of Process <strong>Development</strong> Sciences,<br />
Lonza Biologics plc, United Kingdom<br />
Are There Any Emerging Platforms that Could Supersede CHO<br />
Moderators:<br />
Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture<br />
Process <strong>Development</strong>, World Wide Pharmaceutical Sciences, Pfizer Inc.<br />
Jesús Zurdo, Ph.D., Head of Innovation, Biopharmaceutical <strong>Development</strong>,<br />
Lonza, United Kingdom<br />
How Do We Leverage the CHO Genome Info<br />
Moderators:<br />
Kelvin Lee, Ph.D., Gore Professor of Chemical <strong>Engineering</strong>, Delaware<br />
Biotechnology Institute Faculty Fellow, University of Delaware<br />
Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals,<br />
Professor of Biotechnology, University of Manchester, United Kingdom<br />
Viral Risk Mitigation Strategies<br />
Moderators:<br />
Andy Lin, Ph.D., Process Research & <strong>Development</strong>, Genentech, Inc.<br />
Pamela Hawley-Nelson, Ph.D., Associate Director, Process <strong>Cell</strong> Culture,<br />
MedImmune Inc<br />
Phase-Appropriate, Regulatory Expectations Regarding <strong>Cell</strong><br />
<strong>Line</strong> and <strong>Cell</strong> Culture Processes (Bulk Culture, Non-GMP for<br />
First Human Dose (FHD))<br />
Moderators:<br />
Luhong He, Ph.D., Senior Research Scientist, Eli Lilly and Company<br />
Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie<br />
Agenda:<br />
6:00-7:00 pm Discussion Groups<br />
7:00-8:00 pm Dinner<br />
8:00-9:00 pm Dessert and summaries from each discussion<br />
Additional registration fee required – see page 7 for details<br />
Wednesday, May 22, 2013<br />
7:30 Coffee<br />
8:00 Chairman’s Remarks and Announcement of Poster Winners<br />
Kevin J. Kayser, Ph.D., Director, <strong>Cell</strong> Sciences and <strong>Development</strong>, SAFC<br />
Applying Disruptive Technologies and Their Impact on<br />
<strong>Cell</strong> <strong>Line</strong> <strong>Development</strong> and <strong>Engineering</strong><br />
8:15 <strong>Cell</strong> <strong>Line</strong> <strong>Engineering</strong> Applications of Zinc Finger<br />
Nuclease(ZFN) Technology to Reduce the Risk Profile in<br />
Therapeutic Manufacturing Processes<br />
Zinc Finger Nucleases (ZFNs) are a class of engineered DNA-binding proteins that<br />
facilitate targeted editing of the genome by creating double-strand breaks in DNA at<br />
user-specified locations. We have conducted significant research and development<br />
work to deploy ZFN technology across biopharmaceutical applications. SAFC has<br />
created several new commercial available Chinese Hamster Ovary (CHO) cell lines<br />
with modifications in specific genes of interest. Example cell lines include CHO<br />
GS-/- and CHO dhfr-/- deletions. This talk begins with an overview of the ZFN<br />
technology and specific CHO cell line engineering applications but focuses on<br />
current research to create CHO cell lines with reduced risk profiles.<br />
Kevin J. Kayser, Ph.D., Director, <strong>Cell</strong> Sciences and <strong>Development</strong>, SAFC<br />
8:45 UNPUBLISHED DATA Next Generation Sequencing Technologies and<br />
Applications in Biomanufacturing<br />
The rapid pace of development of technologies for high throughput analysis of<br />
nucleic acid sequence information is beginning to have an important impact<br />
on cell line development. In this presentation, we discuss an overview of the<br />
variety of next generation sequencing technologies that are available and being<br />
employed to study mammalian cell lines and discuss impact of the application of<br />
these technologies to problems relevant to the biomanufacturing community.<br />
Kelvin H. Lee, Ph.D., Gore Professor of Chemical <strong>Engineering</strong>, Director of the<br />
Delaware Biotechnology Institute, University of Delaware<br />
9:15 CASE STUDY • UNPUBLISHED DATA Generic Characterization of Stable<br />
CHO <strong>Line</strong>s by Next Generation Sequencing<br />
One of the major challenges in biologic drug development is product<br />
heterogeneity as a result of contamination, mutation or alternative splicing in<br />
transcription. Traditional methods such as cloning and Sanger sequencing, etc.<br />
are inefficient and even incompetent in detection of generic variants, especially<br />
in low amount. NGS, a powerful tool in decipher genetic information, was<br />
applied on the task and was demonstrated as a perfect fit in molecular<br />
characterization of biotherapeutics during drug development.<br />
Junjian Liu, Ph.D., Senior Scientist, Global Biologics, Abbott Laboratories<br />
9:45 Networking Refreshment Break<br />
Featured Presentations –<br />
Applying Novel <strong>Development</strong> & <strong>Engineering</strong> Strategies<br />
10:15 Stable Depletion of miR-7 Expression for Improved<br />
Performance of a CHO Batch-Fed Culture<br />
MicroRNAs are an important group of cellular genetic<br />
regulators that display several attractive traits as engineering<br />
targets. Their ability to influence the expression of multiple<br />
proteins and not require the cellular translational machinery means they<br />
might be useful in modifying entire cellular pathways without placing<br />
increased metabolic burden on producer cells. We report on the effect of<br />
constitutive depletion of miRNA-7 using decoy transcripts on the growth and<br />
productivity of CHO cells in fed-batch culture.<br />
Niall Baron, Ph.D., Senior Research Scientist, National Institute for <strong>Cell</strong>ular<br />
Biotechnology, Dublin City University, Ireland<br />
10:45 CASE STUDY • UNPUBLISHED DATA Technology Toolbox<br />
for <strong>Cell</strong> <strong>Line</strong> <strong>Development</strong> – Towards High<br />
Speed, Yield and Clonal Stability<br />
State of the art CHO platforms allow generation of high<br />
yielding production cell lines with short cycle times. Our<br />
strategy for further optimizing speed and yield of our CHO platform<br />
combines internal efforts with systematical screening and evaluation of<br />
external know-how. By integrating internal and external technologies we<br />
are aiming for further reducing cycle times and screening efforts of cell line<br />
development. Some novel vector technologies that we have evaluated to<br />
improve our platform towards high yielding fast processes, including a new<br />
selection marker and a targeted integration technology, will be presented.<br />
Thomas Jostock, Ph.D., Novartis Leading Scientist, Novartis Pharma AG,<br />
Switzerland<br />
11:15 Technology Workshop Opportunity<br />
For more information, please contact Jennifer Thebodo at 508-614-1672<br />
or jthebodo@ibcusa.com<br />
11:45 Lunch on Your Own<br />
New to the Field<br />
Consider Attending IBC’s Two-Day Intensive Training Course:<br />
<strong>Cell</strong> Culture and Fermentation Bioprocessing (separate registration required)<br />
East and West Coast Locations:<br />
May 14-15, 2013 in San Diego, CA •June 12-13, 2013 in Cambridge, MA<br />
Full course details available at www.IBCLifeSciences.com/Courses<br />
6 Register Early for Best Savings • www.IBCLifeSciences.com/<strong>Cell</strong><strong>Line</strong> • 800-390-4078