Cell Line Development & Engineering

IBC’s 9th Annual
Cell Line Development
& Engineering
Hear Case Studies from
Genentech, Lonza,
MedImmune, Abbott, Pfizer,
Boehringer Ingleheim,
Eli Lilly, BMS, Novartis
& more...
Improve All Aspects of Bioproduct Development by
Leveraging Cutting-Edge Technical and Process Innovation
May 20-22, 2013 • Hyatt Regency La Jolla at Aventine • La Jolla, CA
Gain Perspectives from Exclusive Case Studies
and Unpublished Data to Help You –
➜ Develop a Custom Cell Line Toolbox with Diverse
Product Quality Attributes
➜ Utilize Molecular Assessment Programs to Balance
Upstream Work with Downstream Payoffs
➜ Apply Next Generation Sequencing Technologies in
Biomanufacturing
➜ Integrate Multiple Omics Data Sets to Understand
Growth Rate Regulation in CHO
➜ Overcome Cell Line and Process Development
Challenges for Biosimilars
➜ Incorporate High Throughput Imaging to Increase
the Assurance of Clonality
Gold Sponsor: Silver Sponsor:
Bronze Sponsors:
Premier Publication:
Keynote Presentations
Coordinated Oscillations in Cortical
Actin and Ca(2+) Correlate with
Cycles of Vesicle Secretion
Roy Wollman, Ph.D.
Assistant Professor,
Chemistry and Biochemistry
University of California San Diego
Higher-Faster-Further: Why It Makes
Sense to Invest in Innovation to Achieve
Disruptive Improvements
Torsten W. Schulz, Ph.D.
Director, Cell Culture,
Boehringer Ingelheim Fremont, Inc.
Featured Presentations
Stable Depletion of miR-7 Expression
for Improved Performance of
a CHO Batch-Fed Culture
Niall Baron, Ph.D.
Senior Research Scientist, National
Institute for Cellular Biotechnology,
Dublin City University, Ireland
Technology Toolbox for Cell Line
Development – Towards High Speed,
Yield and Clonal Stability
Thomas Jostock, Ph.D.
Novartis Leading Scientist
Novartis Pharma AG, Switzerland
www.IBCLifeSciences.com/CellLine

Join Industry Leaders at IBC’s 9th Annual
Cell Line Development & Engineering
May 20-22, 2013
Hyatt Regency La Jolla at Aventine
La Jolla, CA
IBC’s Cell Line Development & Engineering conference is driven by the novel
approaches and emerging tools that are designed to save you time and money
during the process of selecting, developing and engineering your cell lines.
In 3 information packed days, you hear experiences, successes and lessons
learned from companies utilizing the rapidly expanding technology toolbox to
dramatically improve the speed of cell line development, minimize risk, and
increase process and product quality.
Industry leaders and world-renowned academics share exclusive case studies and
unpublished data, providing you with the information required to overcome your
toughest challenges and help your company achieve:
• The promise of ‘omics technologies in process development
• High production stability with targeted integration
• Improved cell density and prolonged viability with stable depletion of miR-7
• Lead candidates with optimal stability, productivity, safety and delivery
characteristics from early developability assessments
• Improved collaboration at the interface of development and discovery
• Better understanding of gene expression regulation with next
generation sequencing
• Big timeline reductions through engineering of host cell line and
expression vector
• In process control of glycosylation during high yield production
Gain Recognition from Your
Peers and Present a Poster
Sponsored by:
IBC’s Cell Line 2013 SAFC Young Investigator
Poster Awards are dedicated to recognizing
the recent achievements of graduate students,
post docs and research scientists that are
driving this field forward.
Posters are reviewed and judged by the Scientific Advisory Committee
for most novel application by a graduate student, post doc and research
scientist. The three winning posters will be announced during the conference
on Wednesday, May 22nd at 8am.
The deadline to submit an abstract for inclusion in the conference materials is
Monday, April 29, 2013 (Abstract and full payment of conference and poster
fees must be received by this date.) After that date, posters are on a space
available basis.
To submit your poster and for additional details on the poster sizes and
regulations, please visit www.IBCLifeSciences.com/CellLine. Only one poster
presentation will be allowed per registered attendee/author.
Gold Sponsor
Pall’s leading edge separation, purification, cell culture, analytical
technologies and services play an essential role in the Life Sciences
industry. Pall single-use and traditional filtration, chromatography,
fluid handling, sampling, monitoring and quality assurance
products and engineered systems, together with technical services
in validation, assays and process optimization are applicable to all
phases and scales of therapeutic, vaccine, and diagnostic product
research, development and manufacturing.
Silver Sponsor
Life Technologies is a global leader in bioprocessing, supporting
biologics based therapeutics and vaccines from molecule to market
with leading brands such as Gibco ® cell culture products and cell
therapy systems; POROS ® chromatography; and SEQ pharmaceutical
analytics. Our portfolio of bioproduction services includes cell line
development and media optimization.
Bronze Sponsors
Poster Award Sponsor
Technology Workshop Sponsors
Badge and Lanyard Sponsor
Conference Supporter
Exhibitors (as of January 11, 2013)
ATR, Inc
Molecular Devices
Life Technologies
Pall Life Sciences
MaxCyte
TAP Biosystems
Drive Your Global Sales and Marketing
IBC’s Bioprocessing Series events provide a number of
sponsorship and exhibiting opportunities you can choose from
to meet your goals before, during and after the event. IBC’s
sponsorships ensure you the proper balance between attendees
and exhibitors so you can spend more time developing
your deals and less time searching for possible partners.
Sponsorship/Exhibiting opportunities include Technology
Workshops (including a thirty minute speaking slot); Session
Sponsorships; Reception, Luncheon and Break Sponsorships;
Delegate Focus Groups; Imprinted Giveaways; and much more.
To learn more about sponsoring or exhibiting, please contact:
A-L: Jennifer Thebodo at 508-614-1672
or jthebodo@ibcusa.com
M-Z: Ellen Moorehead at (508) 614-1406
or emoorehead@ibcusa.com
2 Register Early for Best Savings • www.IBCLifeSciences.com/CellLine • 800-390-4078

Monday, May 20, 2013
7:00 Registration and Coffee
8:00 Chairwoman’s Opening Remarks – The Legal, Regulatory
and Technical Landscape
Laurie Donahue-Hjelle, Ph.D., Director, New Product Development,
Life Technologies
Keynote Addresses
8:15 CASE STUDY Coordinated Oscillations in Cortical
Actin and Ca(2+) Correlate with Cycles of
Vesicle Secretion
The actin cortex both facilitates and hinders the exocytosis
of secretory granules. How cells consolidate these two
opposing roles was not well understood. Here we show using multi-color
fluorescent microscopy that antigen activation of mast cells induces
oscillations in Ca(2+) and PtdIns(4,5)P(2) lipid levels that in turn drive
cyclic recruitment of N-WASP and cortical actin level oscillations. These
oscillations increase secretion efficiency, explaining how the actin cortex can
function as a carrier as well as barrier for vesicle secretion.
Roy Wollman, Ph.D., Assistant Professor, Chemistry and Biochemistry,
University of California San Diego
8:45 CASE STUDY • UNPUBLISHED DATA Higher-Faster-Further:
Why It Makes Sense to Invest in Innovation to
Achieve Disruptive Improvements – A Case
Study About 2nd Generation Media Development
The pressure to reduce COGS will likely increase. The
biopharmaceutical industry needs to pro-actively address this development
by having the appropriate strategies to increase productivity significantly. This
requires a dedicated commitment to innovative ideas that include state of the art
scientific approaches for significant improvements. The case study correlates the
investment in innovation with the outcome of a multi-year innovation project.
Torsten W. Schulz, Ph.D., Director, Cell Culture,
Boehringer Ingelheim Fremont, Inc.
9:15 Speed Networking Refreshment Break and Poster/Exhibit Viewing
Working Closer with Drug Discovery and Research to
Improve Cell Line Development and Minimize Risk
10:15 UNPUBLISHED DATA Cell Line Development for Novel
Molecules - Perspectives from the Interface of
Discovery and Development
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/CellLine for updates.
Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie
10:45 CASE STUDY • UNPUBLISHED DATA Molecular Assessment (MA)
Programs – Balancing Upstream Work with
Downstream Payoffs
Producing recombinant proteins and antibodies with manufacturability
problems often presents a significant barrier to the clinical and commercial
feasibility of a project. Methods to identify problematic molecules early in the
drug development process can serve a valuable purpose by either eliminating
these molecules from consideration or by providing advance notice so that
proactive steps can be taken to minimize timeline delays. This presentation
describes selected Molecule Assessment (MA) considerations implemented at
Genentech, highlighting examples identified at different stages in the process.
Laura Simmons, Senior Scientist, Early Stage Cell Culture, Genentech, Inc.
“Quite worthwhile!
Informative, encompassing, broad and yet relevant topics.
Great venue for discussion and interaction.”
- Lynn Davis, Ph.D., Senior Research Biologist, Bend Research Inc.
11:15 CASE STUDY • UNPUBLISHED DATA Surviving the Valley of Death - Pre-
Cell Line Generation Strategies to Reduce Attrition in Later
Stages of Biopharmaceutical Development
The majority of new biopharmaceutical candidates fail during preclinical
and clinical development in what some describe as the ‘valley of death’
of drug development. The challenge faced by drug developers is to find
new ways of screening out early on in development those compounds
that have a lower probability of success. Developability strategies applied
before the development of production cell lines do address aspects
of manufacturability, safety and delivery that could impact negatively
later stages of development. They constitute an alternative approach to
QbD, targeting risks present in the product itself. It is expected that the
incorporation of this type of assessment early on in biopharmaceutical
development will help reduce cost, attrition and development timelines.
Jesús Zurdo, Ph.D., Head of Innovation, Biopharmaceutical Development,
Lonza, United Kingdom
11:45 Technology Workshop
Simple Methods to Make Your Cell Line Shine
Tremendous efforts have gone into shortening stable cell line development.
Once those months are invested, there is a desire for the selected clone to
shine very quickly with regards to titer and sustainable product quality. This
presentation will explore simple methods to attain next level titers in CHO
fed-batch processes once you’ve selected your expression clone.
Cynthia Hoy, Ph.D, Process Science Fellow, PD Direct® Services –
Life Technologies
12:15 Luncheon and Poster/Exhibit Viewing
1:15 Chairman’s Remarks - Are ‘omics Approaches Anything
other than Intellectual (Academic) Interest - Does Data
Obtained have Track Record of Translating to Making a
Difference in Processes
Kevin McCarthy, Ph.D., Group Leader for Cell Sciences, EMD Serono Inc.
Application, Integration and Characterization of ‘Omics
in Cell Line Development
1:30 UNPUBLISHED DATA Application of Genomic Technologies
to Cell Line Development
The recent publication of a draft CHO genome has set the stage for detailed
molecular and genetic understanding of growth and protein production in
mammalian cells, which will enable - the recognition of patterns of gene expression
that correlate to process suitability and allow knowledge based selection of clones;
development of pathway engineering strategies to improve the host cell line;
process, media and feed development by optimisation of cellular responses.
Nicole Borth, Ph.D., Professor, Department of Biotechnology,
University of Bodenkultur, Austria
2:00 UNPUBLISHED DATA Development of a CHO
Mass Spectrometry Database
New sequence information on Chinese hamster ovary cells offers the potential
to improve the interpretation of CHO proteomic results, and thus a greater
understanding of the underlying biological mechanisms of CHO cells in
biopharmaceutical processes. In this presentation, we demonstrate the use
of CHO-specific sequence information to improve the identification of CHO
proteins using mass spectrometry-based proteomic analysis.
Paula Meleady, Ph.D., Senior Research Scientist, Program Leader,
Proteomics Core Facility, National Institute for Cellular Biotechnology,
Dublin City University, Ireland
2:30 UNPUBLISHED DATA Engineering the CHO Genome for Improved
Transgene Integration and Expression
Epigenetic regulatory DNA elements prevent silencing and increase transgene
integration and transcription for high and stable therapeutic production.
We have sequenced the genome and transcriptome of a CHO cell line and of
derived producer cell clones, yielding information on the integration locus,
transgene integrity and copy number. Information on possible mechanisms
allowing vector genomic integration was also obtained, providing approaches
to further optimize transgene integration and expression.
Nicolas Mermod, Ph.D., Professor, Director, Institute of Biotechnology,
University of Lausanne, Switzerland
For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 3

Monday, May 20, 2013 (continued)
3:00 CASE STUDY • UNPUBLISHED DATA Proteomic Analysis of Chinese
Hamster Ovary (CHO) Cells
To complement the recent genomic sequencing of Chinese hamster ovary
(CHO) cells, proteomic analysis was performed on CHO cells including the
cellular proteome, secretome, and glycoproteome using mass spectrometry
and multiple strategies. A total of 6164 grouped proteins were identified. This
first large-scale proteomic analysis enhances the knowledge base about CHO
capabilities for recombinant expression and cell line engineering.
Deniz Baycin Hizal, Ph.D., Chemical and Biomolecular Engineering,
Johns Hopkins University
3:30 Networking Refreshment Break and Poster/Exhibit Viewing
Proliferation and Integration of Data Sets
4:00 Integrated miRNA, mRNA and Protein Expression Analysis
Reveals the Role of Post-Transcriptional Regulation in
Controlling CHO Cell Growth Rate
To investigate the role of microRNA (miRNA) in the regulation of Chinese
hamster ovary (CHO) cell growth, qPCR, microarray and quantitative LC-MS/
MS analysis were utilised for simultaneous expression profiling of miRNA, mRNA
and protein. In this presentation, the biological processes found to be correlated
with CHO cell growth rate is discussed and the analysis of multiple datasets to
identify potential miRNA-mediated regulation demonstrated.
Colin Clarke, Ph.D., Postdoc, National Institute for Cellular Biotechnology,
Dublin City University, Ireland
4:30 UNPUBLISHED DATA Using Metabolite Profiling Data to Make a
Difference to CHO Cell Bioprocesses
Metabolite profiling offers an ‘omics approach that enables a very
immediate read-out of the status of CHO cells in culture. From an
integrated analysis of profile changes, interpretations can be attained of
metabolic phenotype associated with growth and/or recombinant protein
production. This presentation illustrates our molecular understanding of
relationships between feeding, cellular metabolism and desirable phenotype
in CHO cells.
Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals,
Professor of Biotechnology, University of Manchester, United Kingdom
5:00 UNPUBLISHED DATA Genome-Scale Analysis of Chinese Hamster
Ovarian Cell Lines
Over the past 15 years, microbe-based engineering has advanced through
three major innovations: 1) genome sequencing, 2) genome-scale metabolic
models, and 3) tools for genome editing. These have allowed engineers to
identify cellular parts, simulate product synthesis, and manipulate host
genomes to enhance production. Similar advances are now upon us in the
engineering of CHO cell lines for bioprocessing.
Bernhard Palsson, Ph.D., Principal Investigator, Galletti Professor of
Bioengineering, Adjunct Professor Medicine, University of California, San Diego
5:30 Cocktail Reception in Poster/Exhibit Hall
Tuesday, May 21, 2013
7:30 Coffee
8:00 Chairman’s Opening Remarks
Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture
Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc.
Approaches to Improve Process and Product Quality
8:15 CASE STUDY Clonality – Challenges, Approaches and
Lessons Learned
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/CellLine for updates.
Pamela Hawley-Nelson, Ph.D., Associate Director, Process Cell Culture,
MedImmune
8:45 Use of QPCR and DNA Sequencing Tools to Ensure
Product Quality and Safety
Quantitative PCR (Q-PCR) and DNA sequencing are tools that enable rapid,
sensitive and precise quantitation, detection and identification of critical
cellular and process impurities in cell culture manufacturing and product
purification. Additionally, these tools can be utilized in development and
characterization of production cell lines and in routine monitoring of cell line
stability. In this presentation, the applications of these technologies and present
data demonstrating the performance of assays for impurity assessment, cell line
characterization, contaminant detection and identification are reviewed.
Michael T. Brewer, Director, Head of Pharma Analytics, Life Technologies
9:15 UNPUBLISHED DATA High-Throughput Product Quality Assays for
Cell Line and Process Development
Here we present high-throughput (HTP) analytical assays to facilitate rapid
product quality using 96-well plate formats. These HTP product quality assays
include HTP protein quantitation followed by HTP protein purification and
product quality analyses. With these HTP analytical product quality assays we can
assess product quality in the early stage of clone screening, as well as expedite the
cell line and process development.
Shashi Prajapati, Ph.D., Senior Scientist, Cell Culture Development,
High Throughput Analytical Group. Biogen Idec
9:45 Networking Refreshment Break and Poster/Exhibit Viewing
10:15 CASE STUDY • UNPUBLISHED DATA Impact of Media Components and
Process Parameters on Product Color
Health Authorities expect that companies monitor and control the color
of liquid formulations of monoclonal antibodies. Cell culture conditions
and media components were investigated and shown to influence color.
Mechanisms that could explain these effects are discussed. Some process
changes that reduced color also decreased titer, and strategies for reducing
color which avoid productivity impact are discussed.
Natarajan Vijayasankaran, Ph.D., Senior Engineer, Late Stage Cell Culture,
Genentech, Inc.
10:45 CASE STUDY • UNPUBLISHED DATA Viability and Productivity
Improvement on Mammalian Fed Batch Culture
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/CellLine for updates.
Wenge Wang, Ph.D., Senior Principal Scientist, Bioprocess Research and
Development, Pfizer Inc.
11:15 Technology Workshop
A New Bench Scale Single-Use
Bioreactor System
Development of a new bench scale “rocker style” single use bioreactor
will be described, with discussion of physical parameters for design space
definition and performance measurement; with comparison to industry
standard systems. Presentation will conclude with results from CHO
batch culture trials for design validation, showing significant increases in
achievable cell densities and cell productivity.
Charles G. Golightly, Global Product Manager, Pall Life Sciences
11:45 Luncheon and Poster/Exhibit Viewing
Send a group of 3 and the 4th goes FREE!
It’s a fact – attendees walk away with the most value when they
experience it with a peer – there is just too much information available
for one person to capture it all. As a result, we are pleased to offer a
4th free registration when you register 3 people at the standard rate.
For more information call our group sales advocate at 646-895-7445.
4 Register Early for Best Savings • www.IBCLifeSciences.com/CellLine • 800-390-4078

Tuesday, May 21, 2013 (continued)
12:55 Chairman’s Remarks
Andy Lin, Ph.D., Process Research & Development, Genentech, Inc.
Approaches to Improve Cell Line Development Efficiencies,
Resources and Timelines – What is the Impact
1:00 CASE STUDY • UNPUBLISHED DATA Strategies to Fast/Lean POC and
Risk Mitigation
Fast/lean to PoC is highly desired for drug development. However, fast/lean
cell line generation could potentially result in the identification of clonal cell
lines that are only suitable for early-phase development and result in the
need to change cell lines for commercial development, which can pose a
significant challenge in demonstrating consistency of processes/products. In
this presentation, we share recloning case studies as a potential mitigation
strategy to the risks associated with fast/lean to PoC approaches.
Luhong He, Ph.D., Senior Research Scientist, Eli Lilly and Company
1:30 Streamlining Antibody Development Using Large Scale,
CHO Transient Gene Expression (TGE) Followed by Rapid
Production of CHO Stable Pools
Antibody production for early stage antibody development activities is
commonly conducted using transiently transfected HEK cells to produce
adequate quantities of antibody for characterization, while later stage
screening and biomanufacturing rely on CHO-based stable cell lines.
Migration from HEK to CHO cell backgrounds can lead to manufacturing
challenges and changes in post translational modifications that can alter
the antibody’s therapeutic potential. The time line of antibody development
can be greatly streamlined using large scale transient gene expression
(TGE) directly within CHO cells. CHOS cells can be transfected with >95%
transfection efficiency and cell viability using MaxCyte flow electroporation.
MaxCyte transiently transfected CHO cells produce antibody titers > 400
mg/L, enabling greater than 1 gram of protein from 1g/L.
James Brady, Ph.D., MBA, Director of Technical Applications, MaxCyte
2:00 CASE STUDY • UNPUBLISHED DATA Accelerating Cell Line Screening and
Selection Using a Multiplexed 24 Well Microbioreactor and
Streamlined Purification
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/CellLine for updates.
Jessica Wuu, Ph.D., M.S., Senior Scientist, Process Sciences,
Abbott Laboratories
2:30 CASE STUDY • UNPUBLISHED DATA Faster Upstream Development for
Therapeutic Proteins: The Contribution of the GS-KO Host
Cell Line
The GS Gene Expression System is widely used for cGMP manufacturing
of therapeutic proteins using mammalian cells. Currently, thirteen 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 partly through
introduction of a GS-knockout version, CHOK1SV GS-KO, of its standard
CHO host. This talk describes 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
3:00 Networking Refreshment Break and Poster/Exhibit Viewing
Premier Publication:
Media Partners:
Tribute to the Legacy of Marty Sinacore –
Reflections and State-of-the-Art Advances
3:30 Chairman’s Remarks
Sadettin S. Ozturk, Ph.D., Senior Director, Head of Process Development,
MassBiologics
3:45 A Tribute to Marty Sinacore
Marty Sinacore has been one of the contributors of
developing today’s technology used for mammalian cell
based production. Besides being a great scientist Marty has
been the mentor of countless young scientists that now are
part of the backbone of our community. In this
presentation, Tim and Thomas highlight some of
Marty’s work and how it influenced the way we do cell
based manufacturing today.
Tim Charlebois, Ph.D., Vice President,
Technology & Innovation Strategy, Pfizer Inc.
Thomas Ryll, Ph.D., Senior Director, Cell Culture Development, Biogen Idec
4:30 UNPUBLISHED DATA Development of a Custom Cell Line Toolbox
with Diverse Product Quality Attributes
Although the simplicity of having a single, well characterized host upon
which to initiate cell line engineering has many advantages, a one size
fits all approach does have its drawbacks. The range of product quality
attributes achievable will be limited by the intrinsic phenotype of said host
and may not overlap with the optimum profile for a given therapeutic. With
the increased sophistication of engineering tools enabling precise genome
editing or mRNA depletion, it’s now relatively straight forward to develop
modified hosts with tailored made phenotypes. The end result being the cell
line engineer can develop a “toolbox” of varied hosts that can be employed
to insure that critical quality attributes or biosimilarity is achievable.
Scott Estes, Ph.D., Director, Cell Culture Development, Biogen Idec
5:00 The Impact of ‘Omics Technologies on Process
Development – The Promise and the Reality
It was just over 10 years ago that the use of ‘omics technologies started
to make their way into bioprocess development. For many early adopters
of the technology, the promise was a better fundamental understanding
of cell biology that would lead to engineered cell lines that would be
optimized for production of secreted biotherapeutics. That isn’t what
happened, however.
Mark Melville, Ph.D., Senior Director, Bioprocess Development,
Epirus Biopharmaceuticals
5:30 CASE STUDY • UNPUBLISHED DATA Preservation of a Balanced Cell
Culture Environment for Fed-Batch Processes
This presentation demonstrates with examples the effect of cell culture
imbalance on cell growth and productivity, as well as specific solutions to
remedy these issues. A simple solution to revive the drop in cell viability
observed during the late stage of cell culture is also discussed. Finally, a
systematic approach of medium feeding to achieve high cell density, high
viability, and high titer process is also described.
Yen-Tung Luan, M.S., Associate Research Fellow, Bioprocess R&D, Pfizer Inc.
“By narrowly targeting the technologies used
at the border of R&D of biotherapeutics, this event provides
an intensive 3-day review of current, valuable information
for this highly specialized group.”
- Pam Hawley-Nelson, Ph.D., Associate Director,
Process Cell Culture, MedImmune
For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 5

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

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
3EASY WAYS
TO REGISTER:
Industry Fees By March 1, 2013
By March 29,
2013 By April 26, 2013
Standard Rate
After April 26, 2013
Main Conference Plus
Dinner Symposium (Tues PM)
$2299 $2399 $2499 $2699
Main Conference Only $1899 $1999 $2099 $2299
Academic/Govt. Fees* By March 1, 2013
By March 29,
Standard Rate
2013 By April 26, 2013 After April 26, 2013
Main Conference Plus
Dinner Symposium (Tues PM)
$1599 $1699 $1799 $1999
Main Conference Only $1199 $1299 $1399 $1599
Present a Poster to Enhance Your Conference Experience
All poster presenters must be registered conference attendees. The fee to present a poster in addition
to your conference registration is:
Vendors/Supplier*: $300 Pharma/Biotech: $100 Academic/Government: FREE
* Vendor rate is for exhibiting/sponsoring companies and/or posters that upon review are of
commercial/product focus
Venue and Accommodations
Hyatt Regency La Jolla
3777 La Jolla Village Drive, San Diego, CA
Priority Code: B13189PDFWDL
CALL
800.390.4078 or EMAIL
+1.941.554.3500 @ reg@ibcusa.com
WEB
www.IBCLifeSciences.com/CellLine
Special Conference Rate
$229 Per Night Plus Tax
Tel: 858-552-1234 • Central Reservations: 402-592-6464 or 1-888-421-1442
www.lajolla.hyatt.com
Please call the hotel directly at the numbers above before April 19, 2013 to be included in IBC’s dedicated
room block for this conference. Please identify yourself as a participant in IBC’s Cell Line Development and
Engineering conference to receive the reduced room rate. Be sure to make you reservations as soon as possible
as rooms tend to fill up very quickly and all reservations are subject to availability.
Additional Registration Information
For onsite registrations, please add $100.
Program content and speakers subject to change. Conference badges are non-transferable and lost badges will
not be replaced without payment of the full conference registration fee.
Please note that payment is required in advance of the conference. Please make check(s) (in U.S. funds drawn
on a U.S. bank) payable to IBC Life Sciences and attach to the registration form. Confirmation of your booking
will be sent. Should you elect to pay by MasterCard, Visa or American Express, please send your credit card
number, expiration date, name as it appears on card and signature along with the registration form.
Registration Substitutions/Cancellations: If you need to make any changes or have any questions, please feel free to
contact IBC’s customer service team via email at reg@ibcusa.com. Cancellations must be in writing and must be received
by IBC prior to 10 business days before the start of the event. Upon receipt of a timely cancellation notice, IBC will issue
a credit voucher for the full amount of your payment, which may be applied towards registration fees at any future IBC
event held within 6 months after issuance (the “Expiration Date”). All credit vouchers shall automatically expire on the
Expiration Date and shall thereupon become void. In lieu of issuance of a credit voucher, at your request, IBC will issue a
refund less a $595 processing fee per registration. Registrants are advised that no credit vouchers or refunds will be issued
for cancellations received 10 business days or less prior to start of the event, including cancellations due to weather or
other causes beyond the Registrant’s control. IBC therefore recommends that registrants allow for unexpected delays in
making travel plans. Substitutions are welcome at any time. If for any reason IBC decides to cancel this conference, IBC
accepts no responsibility for covering airfare, hotel or other costs incurred by registrants, including attendees, sponsors,
speakers and guests.
SPECIAL NEEDS: If you have a disability or special dietary needs, please let us know in order that
we may address your special needs for your attendance at this show. Please send your special
needs via email to custserv@ibcusa.com.
For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 7

IBC’s 9th Annual
Cell Line Development & Engineering
May 20-22, 2013 • Hyatt Regency La Jolla at Aventine • La Jolla, CA
Keynote Presentations
Coordinated Oscillations in Cortical
Actin and Ca(2+) Correlate with Cycles
of Vesicle Secretion
Roy Wollman, Ph.D.
Assistant Professor,
Chemistry and Biochemistry
University of California San Diego
Higher-Faster-Further: Why It Makes
Sense to Invest in Innovation to Achieve
Disruptive Improvements
Torsten W. Schulz, Ph.D.
Director, Cell Culture,
Boehringer Ingelheim Fremont, Inc.
Featured Presentations
Stable Depletion of miR-7 Expression
for Improved Performance of a CHO
Batch-Fed Culture
Niall Baron, Ph.D.
Senior Research Scientist, National
Institute for Cellular Biotechnology,
Dublin City University, Ireland
Technology Toolbox for Cell Line
Development – Towards High Speed,
Yield and Clonal Stability
Thomas Jostock, Ph.D.
Novartis Leading Scientist
Novartis Pharma AG, Switzerland
IBC’s 9th Annual
Cell Line Development
& Engineering
May 20-22, 2013
Hyatt Regency La Jolla at Aventine
La Jolla, CA
Improve All Aspects of Bioproduct Development by Leveraging
Cutting-Edge Technical and Process Innovation
“
This is an outstanding venue for bringing together experts
in the field, vendors, scientists and other interested parties,
and the collaborative and open environment has always
”
been rewarding. This meeting is on my calendar every year!
– Gene Lee, Ph.D., Director, Protein and Cell Sciences, EMD Serono
www.IBCLifeSciences.com/CellLine