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Cell Line Development & Engineering

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Improve Aspects of Bioproduct Development by Leveraging Cutting-Edge Technical and Process Innovation

May 18-20, 2015 | Parc 55 Hilton | San Francisco, CA

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Agenda

Agenda

  Download the Agenda-at-a-Glance PDF, featuring all 3 co-located events

Monday, May 18, 2015

7:00
Registration and Coffee

8:00
Chairperson's Remarks
Thomas Kelly, Associate Scientist II, J&J Biotechnology Center of Excellence

High-Throughput Platforms for Cell Line Development

Featured Presentation

8:15
CRISPR Design and Specificity for Cell Line Development
Ben Haley, Ph.D., Scientist, Genentech

8:45
Rapid Production of Recombinant Proteins in CHO Using Large-Scale Transfection or Stable Pools
We describe our CHO-EBNA1 transient expression platform for the rapid production of various recombinant proteins. For more difficult-to-express proteins or proteins needed in large quantities, we also developed an inducible CHO pool platform that allows the generation of stable pools expressing high levels of monoclonal antibodies in less than 3 weeks post-transfection. The pools can also be used to derive stable and high-expressing CHO clones for manufacturing therapeutic r-proteins candidates.
Yves Durocher, Ph.D., Team Leader, Recombinant Protein Production - NRC Human Health Therapeutics Portfolio, National Research Council Canada

9:15
Validating the ClonePix as a Method to Assure Clonality
Thomas Kelly, Associate Scientist II, J&J Biotechnology Center of Excellence

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:10
Chairperson's Remarks
Thomas Kelly, Associate Scientist II, J&J Biotechnology Center of Excellence

High-Throughput Platforms for Cell Line Development (continued)

10:15
An Integrated Cell Line Development Platform for Generation of High Yielding CHO and 293 Stable Cell Lines Expressing Monoclonal Antibodies and Recombinant Viral Glycoproteins
Accelerating timelines to deliver stable cell lines with high productivity is challenging, especially for biologics portfolios as diverse as at the Vaccine Research Center at the NIH. The integrated approach to shorten cell line development timeline includes (A) use of host cells pre-adapted to cell line development and production medium, (B) optimization of the expression vectors, (C) improved pre and post-transfection methodology (D) Enrichment using FACS and automated ClonePixTM technology and (E) top clone selection and ranking in micro-scale ambr bioreactor technology. Our second generation integrated platform enabled us to generate high yielding clones expressing monoclonal antibody and difficult to express recombinant viral proteins. The integrated approach reduced the CLD timeline to less than 4 months and also includes a bioprocess model for scale-up development.
Althaf I. Hussain, Ph.D., Director, Cell Line and Preclinical Development [C], Vaccine Production Program Laboratory,Vaccine Research Center, NIAID/NIH

10:45
A High-Throughput Multi-Parametric Clone Screening Approach for the Generation of Production Cell Lines
Kim Le, Senior Associate Scientist, Cell Line Development, Amgen Inc.

11:15
Genome-Wide RNAi Screen Led to Discovery of Important Genes for Recombinant Protein Production
Genome-wide RNAi screen has emerged to be a powerful methodology for deducing gene functions in various diseases. We applied this technology on HEK293 cells to generate a genome-wide profile for recombinant protein expression process. Up to 150 genes associated with enhancement of recombinant protein expression were discovered and important pathways where these genes enriched in were also identified.
Su Xiao, Pre-doctoral IRTA Fellow, Biotechnology Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, NIH

Technology Workshop

11:45
High Throughput Screening for Monoclonal Antibodies to Multiplexed Antigens
We developed a unique screening platform coupling a combination of target-based colony selection and highthroughput flow cytometry to simultaneously screen for antibodies to 5 different antigens. The technology offers significantly higher signal-to-noise ratios than traditional ELISA screens and allows us to rank several thousand antibodies based on target affinity. Specific projects using recombinant proteins and modified peptides will be highlighted.
Ben Hoffstrom, Ph.D., Director of Antibody Development, Fred Hutchinson Cancer Research Center

12:15
Networking Luncheon in Poster and Exhibit Hall

1:25
Chairperson's Remarks
Kevin J. Kayser, Ph.D., Director, Cell Culture Development, SAFC

High-Throughput Platforms for Cell Line Development (continued)

1:30
Rapid Production of Recombinant Proteins and Stable Cell Lines
Success means getting to market fast. Therefore, fast and efficient protein production for drug candidate development, characterization, and selection is critical. Creating a stable cell line for clinic trial takes months to more than a year for complicated proteins. High efficiency, scalable electroporation can reduce stable cell line development timelines by up to 50%, even in difficult-to-transfect cell lines. In this presentation, data will show the rapid production of proteins and cell lines at different scales.
Weili Wang, Ph.D., Principal Scientist, Protein Production, MaxCyte

Progress in Host Cell Engineering

2:00
Late-Breaking Presentation

2:30
Metabolic Flux Analysis
Neil Templeton, Ph.D., Senior Scientist, Bioprocess Development, Merck Research Laboratories

3:00
Networking Refreshment Break in Poster & Exhibit Hall

Progress in Host Cell Engineering (continued)

3:30
Adventitious Agent Contamination Risk Mitigation: Engineering MMV Virus Resistance into CHO Cells
The introduction of animal origin free (AOF) media has significantly reduced the incidence of adventitious virus contamination in biological production systems. Nevertheless, contamination by the parvovirus Mouse Minute Virus (MMV) remains a continuing challenge and on average we see one major episode of MVM contamination every ~5 years. Moreover, parvoviruses are amongst the most resistant viruses known and their small size poses a challenge to nanofiltration systems. Although infrequent, infection of a fermenter can be catastrophic for a producer, resulting in the loss of product, temporary withdrawal from the market and extensive clean down costs, which can reach a total in the tens of millions of dollars. In addition to the loss of associated revenue, a contamination event can also have a potential impact on drug supply, patient safety and have regulatory implications. In this work, we evaluated engineering the CHOZN® GS-/- parental cell line to create a new host cell line that would be resistant to MMV infection by eliminating the major receptors used by the virus to enter cells. The goal was to engineer a host cell line resistant to MVM infection, while maintaining productivity and product quality profiles.
Kevin J. Kayser, Ph.D., Director, Cell Culture Development, SAFC

4:00
MicroRNAs and Apoptosis in CHO Cell Culture- Application for Enhanced Biological Production
MicroRNAs have been shown to be involved in regulation of multiple cellular processes including apoptosis. The presentation will describe the effect of stable inhibition of a pro-apoptotic microRNA expression on recombinant protein production from CHO cells. The engineered cells reached higher maximum viable cell density, extended viability and 40% increased expression of secreted protein.
Joseph Shiloach, Ph.D., Head, Biotechnology Core Laboratory NIDDK, NIH

Panel Discussion:

4:30
Strategies for Optimal Host Cell Engineering
Moderator: Kevin J. Kayser, Ph.D., Director, Cell Culture Development, SAFC

5:00
Networking Cocktail Reception in Poster and Exhibit Hall

6:00
Dinner Discussions
(Additional registration fee required - see registration page for details)
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:
  • GPCRs, Ion Channels and Other Membrane Targets - The Next Hot Targets! Why? What are the Challenges?
    Moderator: Catherine Hutchings, Ph.D., Antibody Alliance Management & Strategic Partnering, Heptares Therapeutics Ltd., United Kingdom
  • Delivery Approaches for Intracellular Biologics
    Moderator: Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd., Australia
  • Strategies for Plasma Half-Life Extension of Biopharmaceuticals
    Moderator: Arne Skerra, Ph.D., Professor, Chief Scientific Officer, XL-protein GmbH, Germany
  • Non-Antibody Targeting Moieties
    Moderator: Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.
  • Clinical Translatability of Current ADC Programs: Does Patient Selection/Tailoring Improve Success
    Moderator: Alan C. Rigby, Ph.D., Vice President, ADC Biology, Eli Lilly and Company
  • Site-Specific Conjugation and its Progress Towards Clinical Development
    Moderator: Jagath Reddy Junutula, Ph.D., Vice President, Antibody Discovery & Development, Cellerant Therapeutics, Inc.
  • CRISPR's Influence on Therapeutic Development
    Moderator: Ben Haley, Ph.D., Scientist, Genentech
  • What Technological Breakthroughs will Make a Difference to Cell line Development: Enthusiasm Tempered by Realism
    Moderator: Alan Dickson, Ph.D., Professor of Biotechnology, Director, Centre of Excellence in Biopharmaceuticals, Co-Director, BioProNET, The University of Manchester, United Kingdom
  • Cell Line Authentication
    Moderator: Leonard P. Freedman, Ph.D., President, Global Biological Standards Institute
  • Smart Polymers as Drug Linkers and to Extend Half-Life
    Moderator: Volker Schellenberger, Ph.D., President and CEO, Amunix Operating Inc.

Tuesday, May 19, 2015

7:30
Coffee

8:00
Chairperson's Remarks
Susan Sharfstein, Ph.D., Associate Professor of Nanobioscience, Colleges of Nanoscale Sciences and Engineering, SUNY Polytechnic Institute

Utilizing Systems Biology for CHO Cell Engineering

8:15
Chinese Hamster Ovary Cell -omics 2.0
For over a decade academic and industrial research groups have studied CHO cells using 'omics technologies to understand the biological processes underpinning efficient biopharmaceutical production. The release of the CHO-K1 cell line genome in 2011 has signalled the beginning of a revolution for the CHO cell biology community. Since then, six additional CHO cell line genomes and two Cricetulus griseus genomes have been published. This talk will outline how these data are rapidly advancing our understanding of the CHO cell biological system. For example, direct analysis of the sequence has enabled studies of genomic instability, chromosomal rearrangements, point mutations and copy number variation. In addition, the improvements in experimental platforms for measuring the expression of mRNA, miRNA and protein made possible by the availability of the CHO genome will be demonstrated. Finally the utility of genome sequence for the translation of these findings to industrial practice through CHO cell engineering approaches will be reviewed.
Colin Clarke, Ph.D., NIBRT Investigator, National Institute for Bioprocessing Research and Training, Ireland

8:45
Production of a Bioengineered Heparin, Cell Engineering and Bioprocess Considerations
Heparin, an animal-derived product, is the most widely used anticoagulant drug in the world. To create a bioengineered heparin, we metabolically engineered CHO cells to produce two exogenous enzymes in the heparin pathway. In this presentation, I will discuss our results from cell line engineering and process optimization including comparison of fed-batch process in shake-flasks, stirred tank reactors, and a novel bioreactor on product yield and quality.
Susan Sharfstein, Ph.D., Associate Professor of Nanobioscience, Colleges of Nanoscale Sciences and Engineering, SUNY Polytechnic Institute

Featured Presentation

9:15
Stable Glycoengineering of CHO Cells
Recent advances in precise gene editing technologies such as ZFNs, TALENs and CRISPR/Cas9 systems have enabled stable engineering of mammalian cells including CHO to produce well defined N and O-glycans. In this lecture we will present state-of-the-art of glycoengineering in CHO to produce more homogeneous glycans and options for novel designed glycan structures.
Claus Kristensen, Ph.D., Professor, University of Copenhagen

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:25
Chairperson's Remarks
Susan Sharfstein, Ph.D., Associate Professor of Nanobioscience, Colleges of Nanoscale Sciences and Engineering, SUNY Polytechnic Institute

Utilizing Systems Biology for CHO Cell Engineering (continued)

10:30
Consequences of Recombinant Protein Load on CHO Cells
Increased recombinant protein (rP) yield (enhanced cell biomass with high specific productivity and product with the correct quality attributes) remains a clarion call for industry. This presentation will profile how directed expression of rP in CHO cell lines provokes responses that determine the certainty of pR yield and defines approaches to accelerate cell line selection and development programs.
Alan Dickson, Ph.D., Professor of Biotechnology, Director, Centre of Excellence in Biopharmaceuticals, Co-Director, BioProNET, The University of Manchester, United Kingdom

11:00
Understanding Genomic Stability of CHO Cells from Cytogenetics to Sequence Variation
Due to clonal selection and varying culture conditions, CHO cells are continuously subject to mutational forces, ranging from point-mutations, to large-scale chromosomal rearrangements, to chromosomal number to epigenetic modifications. All of these may impact the stability of producer cell lines and process phenotypes. With various cytogenetic and DNA fingerprinting methods, we assessed the degree of chromosomal and sequence variation in long-term cultures of different CHO cell lines, thus providing a unique perspective of genome stability in CHO cells.
Vaibhav Jadhav, Ph.D., Scientist, Austrian Centre of Industrial Biotechnology GmbH, Austria

11:30
Technology Workshop Presentations

12:00
Networking Luncheon in Poster and Exhibit Hall

1:25
Chairperson's Remarks
Richard Neve, Ph.D., Scientist, Discovery Oncology, Genentech

Cell Line Authenticity

Featured Presentation

1:30
Leonard P. Freedman, Ph.D. Irreproducibility: Changing the Policies and Culture of Cell Authentication
A pervasive contributor to irreproducible life science research is the widespread use of misidentified or contaminated cell lines. What is needed to eradicate this decades-old problem is a culture change from top-to-bottom—from researchers to funders to publishers—that embraces best practices and standards, the importance of cell authentication, and use of high-quality biological resources.
Leonard P. Freedman, Ph.D., President, Global Biological Standards Institute

2:00
Improving the Culture of Cell Culture: Addressing the Need for Cell Line Authentication, Quality Control and Annotation
The use of cell lines and biosamples are widespread in biomedical research. Contamination of stocks and confusion of cell line/sample origin frequently occur, resulting in wasted research funds and delaying development of important medicines for patients. This presentation outlines solutions for these issues by defining a framework of quality controls and best practices to prevent and detect the most common forms of cross-contamination.
Richard Neve, Ph.D., Scientist, Discovery Oncology, Genentech

2:30
Assessment of Clonality for Production Cell Lines via High-Resolution Imaging
Demonstrating clonality is a prerequisite for all commercial production cell lines. We have evaluated the use of the Cell Metric as a tool that provides single cell images to prove clonality instead of the traditional mathematical calculations. Data from our characterization experiments and potential implementation into Takeda's cell line development platform will be discussed.
Melisa Carpio, Senior Research Associate II, Cell Engineering, Takeda California

3:00
Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing

Improving Product Quality, Biosimilarity, and Assuring Clonality and Stability

3:45
Three Steps to Start You on the Path to Obtaining the "Best' Recombinant CHO Cell Line: Host Cell Line, Vector and Cell Line Development Process
Demonstrating clonality is a prerequisite for all commercial production cell lines. We have evaluated the use of the Cell Metric as a tool that provides single cell images to prove clonality instead of the traditional mathematical calculations. Data from our characterization experiments and potential implementation into Takeda's cell line development platform will be discussed.
Alison Porter, Head of Mammalian Cell Culture R&D, Fujifilm Diosynth Biotechnologies

4:15
Improving Efficiency, Productivity and Timelines in Cell Line Development through Site-Specific Integration Technology
Mara Inniss, Post-Doctoral Fellow, Pfizer

4:45
Close of Tuesday Sessions

5:00
Join Us... Happy Hour @ Pier 39 Overlooking San Francisco Bay
This networking reception is at Players Sports Grill & Arcade, which has sweeping views of San Francisco Bay. Enjoy buffet finger food and drinks (beer, wine, soft drinks) plus arcade games and pool tables. Transportation will be provided. Limited tickets for this event remain for an additional $125 fee. If you want to register for this reception, please stop by the registration desk to reserve your spot.

Wednesday, May 20, 2015

7:30
Coffee

8:00
Chairperson's Remarks and Announcement of Poster Awards
Kevin J. Kayser, Ph.D., Director, Cell Culture Development, SAFC

Innovation with Alternative Expression Systems and Novel Host Cell Lines

8:15
Use of the Site-Specific Retargeting Jump-In Platform Cell Line to Support Biologic Drug Discovery
Biologic Discovery necessitates the generation of clonal transfected cell lines to achieve high expression of target genes. The site specific targeting of transgene has transformed the ability to generate stably transfected cell lines. I describe the use of the Jump-In™ platform to support drug discovery to rapidly generate homogeneous high expressing cell pools suitable for immunization and cell based assays.
Robin Butler, BSc, Senior Manager, R&D, MedImmune

8:45
Development of a Human Host Cell Line for the Production of a Hemophilia Therapeutic
Mark Tié, Senior Associate Scientist, Biogen Idec

9:15
An Open Cell Free Protein Synthesis Platform to Discover Novel Antibodies and Bispecifics
Using our cell free expression platform, Sutro can expression of antibodies and fragments using a bacterial extract system. We can quickly discover novel antibody fragments (e.g. scFv and Fabs) to any relevant disease target using ribosome display with our extract system. Finally, we can reformat these antibody leads in a many different bispecific frameworks and test them for binding and functionality. Several case studies will be presented to exemplify the power of this system for antibody and bispecific discovery.
Aaron K. Sato, Ph.D., Vice President, Research, Sutro Biopharma, Inc.

9:45
Networking Refreshment Break

Keynote Presentations

10:15
Matthew Croughan, Ph.D.
30 kg of Antibody Per Batch from High Density Single-Use Bioreactors
Matthew Croughan, Ph.D., Industry Professor, Amgen Bioprocessing Center and Founding Professor, Bioprocessing Program, Keck Graduate Institute

10:45
Michael Betenbaugh, Ph.D. Glyco Engineering:In Silico versus In Cells
Michael Betenbaugh, Ph.D., Professor and Chair, Johns Hopkins University
Michael Betenbaugh, Ph.D., Professor and Chair, Johns Hopkins University

Cell Line Development and Modification for Novel Modalities and Difficult-to-Express Proteins

11:15
Cell Line Development for a Measles Vaccine as a Multiple Myeloma Treatment
A complete clinical response was recently achieved in a patient with multiple myeloma after systemic treatment with a single, high dose of Measles Virus (MV). The large-scale production and purification of MV for human use is particularly challenging since MV is a large, fragile, enveloped virus that requires the use of aseptic techniques throughout virus production and downstream purification. The development of the current MV manufacturing process for oncolytic virotherapy will be discussed.
Mark J. Federspiel, Ph.D., Director, Gene and Virus Therapy Shared Resource, Mayo Clinic Comprehensive Cancer Center

11:45
Technology Workshop Presentations

12:15
Lunch on your Own

1:25
Chairperson's Remarks
Arnaud Poterszman, Ph.D., Research Director, Integrated Structural Biology, IGBMC, Strasbourg University, France

Cell Line Development and Modification for Novel Modalities and Difficult-to-Express Proteins (Continued)

1:30
Presentation by MedImmune UK

2:00
Advances and Challenges in the Analytical Characterization of Biosimilar Products
At the core of every biopharmaceutical development program is the challenge to successfully produce active and high quality protein, however for biosimilars additional challenges arise in demonstrating the comprehensive analytical comparability to the reference product. Utilizing our technology, Pfenex has rapidly accelerated the development of a biosimilar candidate, demonstrated analytical biosimilarity and progressed the product into clinical trials.
Jeff Allen, Ph.D., Director of Protein Sciences, Pfenex

2:30
Advances in Baculovirus Expression for the Production of Difficult to Express Proteins and Complexes
The production of sufficient quantities of homogenous protein samples not only is an essential prelude for structural investigations but also represents a rate-limiting step for many human functional studies. Although technologies for expression of recombinant proteins and complexes have been improved tremendously, in many cases, protein production remains a challenge and can be associated with considerable investment. We present here recent advances for expression screening and for production of multi-subunit complexes in the baculovirus expression system using human multi-subunit transcription factors as model systems: Vector development for parallel expression/co-expression screening, use of Lambda red recombination in E. coli for manipulation and improvement of the baculoviral genome and assembly of multi-gene constructs from synthetic biology approaches. We will also discuss use of fluorescent proteins as infection makers and tools for standardization.
Arnaud Poterszman, Ph.D., Research Director, Integrated Structural Biology, IGBMC, Strasbourg University, France

3:00
Roundtable Discussions & Networking Refreshment Break

Manufacturability Assessment Strategies

3:30
NGS Cell line Quality and/or Miss-Splicing and/or Manufacturability Screening Funnel
Stephanie Rieder, Ph.D., Principal Research Scientist, AbbVie

4:00
Early Detection of Sequence Variants During Cell Line Development
Scott Estes, Ph.D., Director, Cell Culture Development, Biogen Idec

4:30
Comparative Glycomics for Early Stage Quality Assessment of mAbs
Highly sensitive analytical methods are required for the determination of critical quality attributes at all stages of bioprocess development. Here, we describe a sensitive method for the quantitative structural assessment of the N-glycosylation present on monoclonal antibodies. We also describe the development of an ultra-sensitive glycan analysis platform for quality assessment during early stage development using limited amounts of protein.
Jonathan Bones, Ph.D., Principle Investigator, National Institute for Bioprocessing Research and Training, Ireland

5:00
Close of Conferences