August 21-22, 2013
Cambridge Healthtech Institute’s 5th Annual
Optimizing Cell Line Development
Enhancing Expression
Day 1 | Day 2 | Short Courses | Download Brochure
Wednesday,
August 21
7:45 am Registration & Morning
Coffee
8:15 Chairperson’s Remarks
8:20 Opening Keynote
Presentation:
Achievements, Challenges and
Future of the Manufacture of Pharmaceutical Proteins with Animal Cells in
Bioreactors
Florian M. Wurm, Ph.D., Professor,
Chemistry Engineering & Cell Bio Lab, School of Life Sciences, Integrative
Bioscience Institute, École Polytechnique Federale De Lausanne (EPFL), and
Founder & CSO, ExcellGene SA
The g/L yield range for CHO-derived
proteins has become standard today. Higher yield is no longer a true goal for
today’s development teams. However, more robust and more predictable processes,
executed under reduced timeframes and established at a lower cost is essential,
since an ever larger number of product candidates will require at least phase
I/II evaluations. This talk will highlight key developments and will also give
a view on the future of manufacturing in this field.
9:00 Featured Presentation:
Rapid Generation of Stable
CHO Pools and Clones
Yves Durocher, Ph.D., Senior
Research Officer, Biotechnology Research Institute, National Research Council
Canada
We will present data describing our
new platform that allows the generation of stable CHO pools capable of
producing up to 700 mg/L of monoclonal antibodies (Mab) in less than 30 days
post-transfection. We believe that this platform is a viable alternative to
large-scale CHO transfection when multi-gram quantities of r-protein candidates
are needed for therapeutics development. As clones producing g/L quantities of
Mab can be rapidly isolated from the pools, this also makes our platform very attractive
for the manufacturing of biologics.
9:30 Case Study: Fast Cell Line and
Process Development
to Produce a Complex Novel IL2-Based Immunocytokine in High Quality
Ingo Gorr, Ph.D., Senior Scientist,
Cell Culture Research, F. Hoffmann-La Roche
In this case study a fast but
elegant strategy for cell line selection and development of a manufacturing
process for a novel IL2-based immunocytokine for cancer therapy is presented.
Here, only CLD, USP and DSP together are capable of reducing critical impurities.
Intriguing strategies to achieve a high quality therapeutic protein in
combination with accelerated timelines are highlighted.
10:00 Coffee Break in the Exhibit
Hall with Poster Viewing
10:45 Optimization of Cell Lines for Antibiotic-Free Bioproduction
Benjamin Michel, Ph.D., Project
Manager,
Delphi Genetics SA
Delphi Genetics develops
technologies which enable bioproduction without using antibiotics in line with
the regulatory guidance (FDA, USDA and EMA). Moreover, these technologies
permit an increase of yield (protein or pDNA) by avoiding a burden of energy
due to expression of antibiotic resistance gene.
11:15 Optimizing Cell Line
Development for Optimal Expression of Bispecific DARTT Molecules
Valentina Ciccarone, Ph.D.,
Principal Scientist, MacroGenics, Inc.
11:45 Sponsored Presentation
(Opportunity Available)
12:00 pm Luncheon Presentation
(Sponsorship Opportunity Available) or Lunch on Your Own
1:55 Chairperson’s Remarks
2:00 Impact of miR-7 Over-Expression
on the Proteome of Chinese Hamster Ovary Cells
Paula Meleady, Ph.D., Senior
Research Scientist and Programme Leader, National Institute for Cellular
Biotechnology, Dublin City University
MicroRNAs play critical roles in
the regulation of biological processes thus representing potential engineering
routes towards enhancing desirable characteristics of mammalian cells for
biopharmaceutical production. We have carried out quantitative label-free
LC-MS/MS proteomic analysis of CHO cells following over-expression of miR-7,
which we have found to alter growth and productivity of CHO cells.
Understanding the cellular pathways involved in this phenotype might open the
way to new strategies for bioprocess-relevant growth regulation.
2:30 Optimization of a Therapeutic
Protein Expression Platform
Jianxin Ye, Ph.D., Research Fellow,
Merck Research Labs
In order to increase the efficiency
of cell line development and improve yield, we have explored optimization of a
CHO-based expression system. A combination of different approaches has been
explored for this purpose, including host cell adaptation/selection, expression
vector design, medium/feed optimization, automated cell culture system, etc.
With the combination of these different approaches, an improved CHO expression
platform was developed.
3:00 Application of Next-Generation
Sequencing and Scale-Down Model on Stable CHO Line Development
Sheng Zhang, Ph.D., Senior
Scientist, Process Sciences, Abbvie Bioresearch Center
In this case study, we successfully
implemented the deep-well scale-down fed batch and the next-generation
sequencing of transcriptome throughout the cell line development practice that
ultimately led us to the best production clone expressing the correct recombinant
mAb. By integrating these two powerful tools in our CLD platform, we
demonstrated significantly improved efficiency of clone selection towards
greater titer and less risk of product heterogeneity.
3:30 Refreshment Break in the
Exhibit Hall with Poster Viewing
4:15 The Isolation of CHO Cells
Capable of High Transgene Amplification Rates
Jonathan Cacciatore, Ph.D., Research
Scientist, Chemical Engineering and Biological Sciences, Columbia University
A widely used method for isolating
Chinese hamster ovary (CHO) cell lines is the selection of clones that have
undergone amplification of the transgene coding for the protein. This method is
very time consuming and erratic. We employed a method that measures
amplification rate at various genomic locations to identify a high-producing
clone. We utilized site-specific recombination to target a gene coding for a
marker protein into this genomic location and confirmed high gene amplification
rate and protein secretion.
4:45 High-Throughput Transfection of
Silencing RNA into 3D Cell Cultures
Susan Sharfstein, Ph.D., Associate
Professor, Nanobioscience, Nanoscale Science and Engineering, University at
Albany, State University of New York
The wealth of genome-sequence
information and transcriptomic data generated by sequencing projects and
microarray studies, has created a demand for high-throughput methods for
annotating gene function. In this talk, I will describe high-throughput
approaches for transfecting silencing RNA into culture mammalian cells using novel
magnetic nanoparticles and high-throughput viral delivery approaches with an
objective of understanding how process conditions affect cell physiology and
recombinant protein production in culture mammalian cells.
5:15 Networking Reception with Exhibit
& Poster Viewing
6:45 End of Day
Day 1 | Day 2 | Short Courses | Download Brochure