Cell Line Development & Engineering

12:55 Chairman’s Remarks
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.
Steffen Goletz, Ph.D., Chief Executive Officer, Chief Scientific Officer,
Glycotope GmbH, Germany
1:30 UNPUBLISHED DATA Challenges in Cell Line and Process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
2:00 2nd Generation Sequencing for Cell Line Characterization
during Biosimilar Development
Biosimilar cell line development is a multi-step process, based on quality by
design principles to generate a cell line producing a recombinant protein
as similar to the originator’s protein as possible. Essential part of cell line
development is genetic characterization. In addition to standard techniques,
2nd generation sequencing technologies enable deeper look into the parts of
genome and transcriptome interesting for cell line developers.
Dominik Gaser, Ph.D., Senior Scientist, Cell & Molecular Biology,
Sandoz Biopharmaceuticals, Slovenia
2:30 Networking Refreshment Break
Implementation of Analytical Tools and Strategies to
Help Improve Clone Selection, Process Monitoring,
Understanding and Development
3:00 UNPUBLISHED DATA High Throughput Imaging During Cell Line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.
3:30 CASE STUDY • UNPUBLISHED DATA 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 Productivity
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.
Wednesday, May 22, 2013 (continued)
4:00 CASE STUDY • UNPUBLISHED DATA LC-MS/MS and Data Searching
Strategies for Sequence Variance Detection
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.
4:30 Scale-Down Automated Purification and Protein Analytics
to Facilitate Cell Line Screening/PQ Analysis
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/CellLine for updates.
Ling Santora, Ph.D., Senior Scientist III, AbbVie
5:00 Close of Conference
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