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Increase Efficiency and Yield in Established and Developing Cell Lines

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

June 13-15, 2016
Parc 55 Hilton
San Francisco, CA

Agenda

Agenda

Monday, June 13, 2016

8:15
Opening Remarks from Scientific Advisory Board
Michael Butler, Ph.D., Distinguished Professor, Microbiology, University of Manitoba, Canada

High-Throughput Platforms for Cell Line Development

Session Chairperson: Michael Butler, Ph.D., Distinguished Professor, Microbiology, University of Manitoba, Canada

Keynote Presentation

8:30
Case StudyNew Data
Platform Development Incorporating Sony SH800 Cell Sorter, ClonePix 2, and ambr15 Technologies for Monoclonal Antibody Expression in CHO-DG44
We have utilized FACS-based enrichment, ClonePix 2 clone selection and ambr15 microbioreactor technologies to standardize and improve our clone generation and top clone selection protocols for monoclonal antibody development in the CHO-DG44 platform.
Elizabeth H. Scheideman, Scientist, Cell Line Development, Vaccine Production Program, NIH

9:15
Meta-analysis Supports Aggressive Timeline Reduction for Cell Line Construction (CLC)
Meta-analysis of CLC data supports improvements to our miniature bioreactor model, host, transfection and selection strategies. These improvements reduced the timeline for CLC by greater than a month, while benefitting overall quality. Screening cell lines in miniature bioreactors provides quality process information which supports selection of cell lines better suited for cGMP manufacture and achieving critical quality attributes
Paresh Patel, Ph.D., Principal Scientist, Cell Culture Development, Lonza Biologics

9:45
Networking Refreshment Break in Poster & Exhibit Hall

Advances in Host Cell Engineering

Session Chairperson: Shahram Misaghi, Scientist, Genentech

10:15
To Fucosylate or Not: Utilizing FX Knockout CHO Lines to Express Either WT
During antibody dependent cell cytotoxicity (ADCC) the target cells are killed by monocytes and natural killer cells. ADCC is enhanced when the antibody heavy chain's core glycan lacks the fucose molecule(s). Several strategies have been utilized to generate afucosylated antibodies. A commonly used and efficient approach has been knocking out the Fut8 gene of the Chinese hamster ovary (CHO) host cells, which results in expression of antibody molecules with completely afucosylated glycan profiles. However, a major drawback of the Fut8-KO host is the requirement for undertaking two separate cell line development (CLD) efforts in order to obtain both WT and afucosylated antibody species for comparative studies in vitro and in vivo. Even more challenging is obtaining WT and Fut8-KO clones with similar enough product quality attributes to ensure that any observed advantage(s) can be strictly attributed to afucosylation. Here, we report the generation and use of a FX knockout (FXKO) CHO host cell line that is capable of expressing antibody molecules with either afucosylated or WT glycan profiles with similar product quality attributes, dependent upon the addition of fucose to the media. Hence, the FXKO host not only obviates the requirement for undertaking two separate CLD efforts, but it also averts the need for screening many colonies to identify clones with comparable product qualities. Finally, FXKO clones can express antibodies with the desired ratio of WT to afucosylated glycans by titrating fucose to achieve therapeutically optimal levels of ADCC for an antibody.
Shahram Misaghi, Scientist, Genentech

10:45
Case StudyNew Data
Engineering CHO Cell Factories by Directed Evolution
  • Engineered CHO cells with a significantly increased biomass synthesis capability
  • Simple and effective methodology
  • Detailed analysis of mechanism
David C. James, Ph.D., Professor, Bioprocess Engineering, University of Sheffield

11:15
GlycoExpress™: A Toolbox for High Yield Production of Glycooptimized Fully Human Biopharmaceuticals in Perfusion Bioreactors at Different Scales
Glycosylation is one of the major post-translational modifications of biotherapeutics important for bioactivity, bioavailability, immunogenicity and patient coverage. By establishment of the GlycoExpress™ toolbox (GEX™) we have generated a set of glycoengineered human cell lines for high yield production of fully human glycoproteins to optimize the glycosylation of antibodies and non-antibody biotherapeutics for improvement of the clinical efficacy and side effects. The system shows high yield for different classes of glycoproteins including different antibody formats and hormones as well as highly similar glycan structure when comparing lab scales perfusion bioreactors of 10 mL working volume to large scale production reactors including a continuous 1000L single-use bioreactor.
Steffen Goletz, CSO and Founder, Glycotope

Technology Workshop

11:45
CHO Media Optimization Using ambr15 and DoE
Combining bioreactors with Design of Experiment (DoE) approach can provide a systematic solution for biopharmaceutical process development. Sartorius Lonza will present results from experiments with the ambr®15 automated micro bioreactor system and an integrated DoE software (MODDE). These findings demonstrate an enabling technology to provide complete basal and feed media and fed-batch protocol for a given CHO clone.
Michael Gillmeister, Ph.D., Senior Scientist, Lonza

12:15
Networking Luncheon in the Poster & Exhibit Hall

Improving Processes and Product Quality

Session Chairperson: Tharmala Tharmalingam, Ph.D., Scientist, Cell Line Development, Amgen

1:25
New Data
Optimizing Techniques for Mass Spectrometry Detection of Sequence Variants in Support of Cell Line Development
Sequence variants refer to product-related impurities whose amino acid sequences differ from that derived from the expected eDNA sequence. These are of interest during cell line development as they may represent an error in the DNA sequence of the expression vector. This presentation will review applications of liquid chromatography-mass spectrometry to identify sequence variants in support of cell line development.
Thomas Slaney, Ph.D., Scientist I, Molecular and Analytical Development, Biologics Development & Operations, Bristol-Myers Squibb

1:55
Case StudyNew Data
Evaluation of siRNA Technology as a Bioprocessing Tool to Improve Productivity and Product Quality Challenges in CHO
  • siRNA technology is an effective tool that can be applied to CHO bioprocessing
  • siRNA targets were successfully temporally regulated in 3 CHO case studies: LDHA, β1,4 galactosyl transferase and cathepsin D protease
  • siRNA targets can be temporally regulated to improve productivity and control product quality attributes in CHO
Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc

Technology Workshop

2:25
Engineering of CHO Cell Lines for Enhanced Process Robustness
High quality production cell lines secreting maximal levels of recombinant proteins require stable integration of the recombinant DNA, elevated gene transcription, optimized secretion machinery to handle increased protein secretion and folding loads and, ideally, be easily tracked during manufacturing.  Using the data from our CHO-K1 genome and transcriptome, we have engineered our CHO-K1 to address these issues, particularly for difficult-to-express proteins, as well as provide detailed genomic analysis packages for manufacturing cell lines.
Igor Fisch, Ph.D., CEO, Selexis 

2:55
Networking Refreshment Break in Poster & Exhibit Hall

Improving Processes and Product Quality (continued)

3:30
Case StudyNew Data
The Control of Antibody Glycosylation During a Production Bioprocess
The glycoform profile of a monoclonal antibody (Mab) determines many functional properties that affect therapeutic efficacy. Common variations of the conserved Fc glycan include galactosylation, fucosylation and sialylation. The observed glycan profile of the final product can depend upon the producer cell line, the growth media, the culture conditions as well as the Mab protein structure. The presentation will review the parameters that can be controlled in order to minimize batch to batch variation of Mab glycosylation. Strategies will also be discussed to produce Mabs with pre-defined glycan structures.
Michael Butler, Ph.D., Distinguished Professor, Microbiology, University of Manitoba, Canada

4:00
New Data
Utilization of a Small Molecule Cell Cycle Inhibitor to Achieve Cell Cycle Arrest, Improves Specific Productivity and Desired Product Quality of Recombinant Proteins in CHO Cell Cultures
Increasing specific productivity for biologics cell culture processes is critical to enabling cost-effective commercial development. In this study, we demonstrate the use of cell cycle inhibitors in multiple recombinant mAb producing CHO cell lines to achieve growth arrest and increase specific productivity by 2-3 fold. When comparing this approach to other commonly used methods of growth arrest, such as temperature shift, we demonstrate specific benefits in key product quality attributes. Under thermal induced growth arrest we observe an increase in non-desirable high mannose glycans, whereas mAbs produced in the presence of the small molecule cell cycle inhibitor resulted in further processing of glycans with a decrease in high mannose species offset with an increase in galactosylated species. The difference in glycosylation during temperature shifts was attributed to decreased mRNA levels of multiple regulatory genes of the N-linked glycosylation pathway which was not evident in the presence of these small molecule inhibitors. In summary, the use of these small molecule cell cycle inhibitors can optimize cell culture processes resulting in optimal cell growth, specific productivity, and glycosylation profiles of the target recombinant antibody.
Tharmala Tharmalingam, Ph.D., Scientist, Cell Line Development, Amgen

4:30
Human-like Sialylation of IgGs in CHO Cells
To evaluate the impact of Fc sialylation on IgG's effector functions, we produced glycovariants of Herceptin in CHO cells through transient co-expression of Herceptin with various combinations of glycosyltransferases. The glycovariants interactions with FcγRIIIa were analyzed by surface plasmon resonance (SPR). For both highly and poorly fucosylated IgGs, galactosylation and sialylation resulted in the stabilization of IgG/FcγRIIIa complexes.
Céline Raymond, Ph.D., USP Development Engineer, Development Mammalian Unit, Millipore Sigma

5:00
Networking Cocktail Reception in the Poster & Exhibit Hall

Tuesday, June 14, 2016

8:00
Opening Remarks

Improving Biosimilarity

Session Chairperson: Marcio Voloch, Ph.D., VP, Biologics Process Development, Momenta Pharmaceuticals, Inc

Keynote Presentation

8:15
Case StudyNew Data
Process Development Life Cycle for Biosimilars: "Do It Right the First Time"
Unlike a typical development program for a novel molecule where development/manufacturing process changes can be introduced during the clinical trials, biosimilars require significant process development efforts from the beginning. The need for the commercial process to be defined at the timing of the initial regulatory filings requires integration of multiple goals (narrow ranges for quality attributes, cost, validatable, etc) into a single development program.
Join us for an informative talk that will help you:
  • Identify challenges early in the development cycle
  • Prioritize early and often: needs vs. must-haves
  • Exercise discipline in process development
Marcio Voloch, Ph.D., VP, Biologics Process Development, Momenta Pharmaceuticals, Inc

8:45
New Data
An Engineered CHO Cell Line to Efficiently Produce Biosimilar-ZMapp (MIL77) against Ebola infection
  • An engineered CHO cell line was used to produce Biosimilar-ZMapp-MIL77, a monoclonal Ab cocktail developed Ebola virus infection.
  • The protective efficacy of M l:.77 has been confirmed in animal models - at least similar to ZMapp if not better
  • The yield is much higher with this cell line
Xiangguo Qiu, MD, Head, Vaccine Development & Antiviral Therapy, Special Pathogens Program, National Microbiology Laboratory, Public Health Agency of Canada

Technology Workshop

9:15
Rapid, Scalable Production of Recombinant Proteins and Stable Cell Lines
Success for pharmaceutical and biotechnology companies means getting to market quickly. Therefore, fast and efficient protein production for drug candidate development, characterization, and selection is critical. High efficiency, scalable electroporation can reduce stable cell line development timelines by up to 50%, even in difficult-to-transfect cell lines, while producing multi-gram titers. In this presentation, data developed with MaxCyte's flow electroporation system will show the rapid production of proteins and cell lines at different scales and demonstrate the consistent product quality between transient gene expressions and that of stable cell lines.
Dr. James Brady, Vice President, Technical Applications & Customer Service, MaxCyte
Hua Tu, Ph.D., LakePharma, Inc

9:45
Networking Refreshment Break in Poster & Exhibit Hall

Assuring Clonality and Stability

Session Chairperson: Thomas Jostock, Ph.D., Group Head Cell Line Development, Biologics Technical Development and Manufacturing - TD-NBE/Integrated Biologics Profiling, Novartis Pharma

10:15
New Data
NGS for Cell Line Characterization and Improving Expression
  • NGS can be used to characterize transgene integration locus, copy number and sequence integrity
  • NGS also helps identify and engineer the transgene genomic integration mechanism for more reliable expression
  • Characterization of cell clone genomic sequence alterations assesses cell identity and clonality
Nicolas Mermod, Ph.D., Professor, University of Lausanne, Switzerland

10:45
Dispensing One Cell Per Well with High Viability and Image-Based Documentation
The isolation of single cells is prerequisite for biopharmaceutical production, especially in cell line development. Regulatory bodies request manufacturers to prove the clonality of a producer cell line. Cytena developed a patented technology specifically for the process of proven single-cell isolation in cell line development. Comparable to an inkjet printer, the single-cell printer (SCP) dispenses free-flying microdroplets, which are delivered automatically to any cell culture plate. High-resolution microscope images of the dispenser nozzle are automatically processed. A cell analysis algorithm detects cells, their position, size and morphology. With this information, the system can predict the content of each droplet and print droplets containing exactly one cell. Droplets with no or multiple cells are not printed on the substrate. For each individual well an image sequence is stored, tracing the cell's movement to the dispenser nozzle and the cell's ejection. Furthermore, the process parameters and operator inputs are stored together with the cell images in a protected data set.
This talk will present the technological approach, the newest data for cell line development customers and possibilities to access this technology.
Fabian Stumpf, Engineer, cytena GmbH

11:15
Case Study
An Experimental Approach to Establish Probability of Clonality
The FDA requires the equivalent of two rounds of limiting dilution cloning (LDC) to ensure a MCB's clonal origin. The probability of clonality ascribed to LDC in the literature is based on a Poisson distribution. Using RFP and GFP expressing CHO cells the probability of clonality from LDC was determined, and that FACS and imaging exceed two rounds of LDC.
Duncan Mcvey, Principal Scientist, Bristol-Myers Squibb

11:45
Case Study
Cell Line Development Screening Strategies to Confirm Monoclonality and Reduce Timeline of a Bispecific Candidate Molecule
In this session we discuss a case study on how we used the Cell Metric™ CLD system (Solentim) to confirm monoclonality of our lead bispecific candidate molecule, which form an important part of the Regulatory package. This has accelerated our timeline in generating a commercial manufacturing cell line without having to do more than 1 round of limited dilution cloning.
Camilla Wang, Senior Associate Scientist, SystImmune Inc

12:15
Roundtable Networking Luncheon in the Poster & Exhibit Hall

Keynote Presentation

1:25
The Cellca CHO Expression Platform: Preparing for Future Bioprocessing Challenges
In this presentation, we demonstrate that our expression system is suitable for high-titer production of monoclonal antibodies, bispecific antibodies, Fc fusion proteins and Fab-related products, enabling pre-clinical and clinical product supply. The fed-batch performance of our production system is well transferable throughout various cultivation formats including ambrTM15, ambrTM250, 200 L wave-mixed and 1000 L stirred tank bioreactors. Generally, no media and process optimization is required due to simplicity of our well-engineered technology platform. Furthermore, our newly developed fast-track cell line development approach allows cell line generation from DNA to research cell bank within 4-5 months. For sophisticated products such as biosimilars, minor media and process modifications as well as genetic engineering of our host cell line are used to achieve targeted protein quality. The described characteristics make Cellca CHO expression platform the first choice for large-scale manufacturing of biopharmaceuticals as well as for future bioprocessing challenges.
Dr. Brian Wendelburg, Field Marketing Manager, Sartorius Stedim

Spotlight Presentation

2:00
Use of Complex Genome Engineering to Solve the Challenge of Xenotransplantation
Rapid advances in the development of tools for DNA sequencing, analysis, synthesis and assembly provide an opportunity to address previously intractable problems in biology and medicine. Synthetic Genomics has partnered with United Therapeutics to improve xenotransplantation, cross-species transplantation, and is employing cutting-edge synthetic biology technologies to understand the complex processes involved in porcine to human xenotransplantation and relieve the critical unmet need for donor organs.
Sean Stevens, Senior Director, Mammalian Synthetic Biology, Synthetic Genomics

Assuring Clonality and Stability (continued)

2:30
Integrating Vector and Cell Line Technologies to Improve Expression, Stability and Timelines
State of the art CHO platforms allow generation of high yielding production cell lines with short cycle times. Our technology development strategy combines efforts for further optimizing speed and yield of our CHO platform with continuous expansion of our technology toolbox to deal with challenging molecules and special requirements. By integrating vector and cell line technologies we are aiming for further reducing cycle times and screening efforts of cell line development. Some novel technologies that we have implemented to improve our platform and to expand our technology toolbox will be presented.
Thomas Jostock, Ph.D., Group Head Cell Line Development, Biologics Technical Development and Manufacturing - TD-NBE/Integrated Biologics Profiling, Novartis Pharma

3:00
Networking Refreshment Break in Poster & Exhibit Hall

Understanding CHO Metabolisms

Session Chairperson: Nathan E Lewis, Assistant Professor, University of California San Diego

3:30
Genome Scale Metabolic Reconstruction of CHO Cells: What´s in a Model?
In order to increase the production capabilities of CHO cells, targeting the metabolism is becoming increasingly important, as it not only provides the necessary building blocks and energy, but also balances cofactor requirements. The high connectivity of metabolism requires system-wide analyses to identify optimisation strategies and engineering targets. Genome-scale metabolic models have proven to be a valuable tool in guiding metabolic engineering strategies in prokaryotes. Very recently, the first genome-scale metabolic model for CHO was developed within a large community driven cooperation. In this talk the power of this modeling approach will be illustrated, without showing any formulae, by highlighting the insights gained from system-wide changes upon media modification.
David Ruckerbauer, Ph.D., Professor, BOKU University, Austria

4:00
New Data
Obtaining Favorable Product Quality Attributes Through Model-Guided Engineering of CHO Metabolism and Glycosylation
Our release of the Chinese hamster genome sequence now offers a new toolbox for cell line development, as it can provide genetic basis of protein production. By mapping out the pathways influencing recombinant protein production, we can test the efficacy of bioprocess treatments, engineer cell phenotypes, and control glycosylation through model-predicted genetic and media changes.
Nathan E Lewis, Assistant Professor, University of California San Diego

4:30
Case StudyNew Data
Harnessing the Power of Omics for CHO Cell Line Engineering
  • Recent advancements in proteomics, transcriptomics, metabolomics, and glycoproteomics technologies have increased our understanding of CHO physiological pathways.
  • Integration of omics data sets with bioinformatics tools can help to elucidate the monoclonal antibody expression challenges in CHO cells.
  • Mass spectrometry-based secretomics analysis can identify the potential host cell proteins which may have immunogenic effects and also may affect product quality and stability.
Deniz Baycin Hizal, Adjunct Associate Scientists, John Hopkins University

5:00
Offsite Networking Reception
This year's offsite reception will be held on the Rooftop of the Bluestem Brasserie which provides the perfect atmosphere for networking and it is within walking distance of the meeting venue. Join us at this urban eatery for a lively dining experience which includes a tasty brasserie menu, specialty cocktails, and 12 wines sourced from some of Napa and Sonoma's finest vineyards.

Wednesday, June 15, 2016

8:00
Opening Remarks

Genome Editing in CHO Cells

Session Chairperson: Kendra Steele, Ph.D., Senior Research Scientist, ParaTechs

Keynote Presentation

8:15
New Data
Variants in the Engine Room - the CHO Mitochondrial Genome and Engineering Improved Output
  • Deep sequencing of the mitochondrial genome reveal differences across CHO cell lines
  • miRNAs can influence the mitochondrial function of CHO cells
  • Better understanding of this organelle in CHO cells could lead to improvements in CHO production phenotypes
Niall Barron, Ph.D., Senior Research Scientist, Dublin City University

8:45
New Data
The TLA Technology & Comprehensive Targeted NGS Sequencing of Genetic Alterations in Cell-lines
The TLA Technology uniquely enables the targeted complete NGS sequencing of any genomic locus of interest and detection of all Single Nucleotide Variants as well as Structural Changes. TLA empowers the analysis of transgenic cell-lines and enables the targeted complete NGS sequencing of transgenes and their integration sites as well as of all targeted genetic modifications.
Marieke Simonis, Ph.D., Head of Bioinformatics, Cergentis

Rapid Fire Poster Presentations

Our scientific advisors will handpick the top poster submissions and provide them an opportunity to give a brief introduction to their work. Further discussions on posters will be fostered in the exhibiting hall during networking functions.

9:15
Poster Presenter #1

9:30
Poster Presenter #2

9:45
Networking Refreshment Break in Poster & Exhibit Hall

Genome Editing in CHO Cells (continued)

10:15
Update on High-Efficiency Genome Editing: A Host Cell Protein That May Impact Polysorbate Degradataion
This presentation will discuss the use of a gene editing approach to influence host cell protein (HCP) expression. Certain difficult to remove HCPs may have an impact on product quality. We tested the utility of a gene knockout to mitigate the product quality concern related to the use of polysorbates.
Kelvin Lee, Ph.D., Gore Professor of Chemical Engineering, Delaware Biotechnology Institute Faculty Fellow, University of Delaware

10:45
New Data
CRISPR-mediated Gene Integration into Potential Transcriptional Hot Spots in CHO
  • Targeted gene integration into potential transcriptional hot-spots
  • Based on transcriptome analysis, highly expressed genes were identified as potential transcriptional hot-spots
  • CRISPR technology was used to target reporter/product genes into these potential transcriptional hot-spots
  • Characterization of the targeted-integration clones will be presented in this talk
Bo Jiang, Principal Scientist, Merck

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

Session Chairperson: Kendra Steele, Ph.D., Senior Research Scientist, ParaTechs

11:15
New Data
Developing a Targeted Integration CHO Host for Clinical & Commercial Cell Line Development
Unlike the conventional random integration (RI) cell line development (CLD), the targeted integration (TI) CLD introduces the transgene at a predetermined "hotspot" in the CHO genome with a defined copy number (1-2 copies). Given the low copy number and the pretested integration site, TI cell lines likely exhibit better stability compared to RI cell lines. In this study, we performed a genome wide screening using transposon based cassette integration and established a TI host that has a single landing cassette inserted in its genome. This TI host was able to support the CLD for three test molecules with product titers similar to those of the corresponding RI cell lines. For two regular antibody test cases, the top four TI cell lines achieved 4-5 g/L. For a proven difficult to express antibody, the top four TI lines achieved 1-1.2 g/L. The product titer for this hard to express molecule was increased 3-fold with additional vector improvement. Moreover, the timeline for CLD was shortened by ~3 weeks and resources required per cell line were substantially reduced using the TI method. Together these data indicate that the TI host we developed can be a suitable host to support our clinical / commercial CLD.
Yongping Crawford, Ph.D., Scientist, ESCC, Genentech

Technology Workshop

11:45
Engineering of Gene, Vector, and Cell-Lines for Optimized Production of Biologics
The presentation will review how bioengineering tools and machine learning methods are leveraged for the rapid and efficient production of biotherapeutics. Transient and stable CHO/HEK protein expression yield is controlled over orders of magnitude by the systematic incorporation of validated sequence elements including promoters, IRES, PRE, UTR, transposases, viral elements and more.
Kate Caves, Principal Scientist and Director Business Development, DNA2.0

12:15
Networking Luncheon in the Poster & Exhibit Hall

Cell Line Development and Modification for Difficult-to-Express Proteins (continued)

1:30
New Data
Vankyrin-enhanced Sf9 Insect Cells Can Be Used to Purify Toxic Proteins
The baculovirus expression vector system (BEVS) is a versatile protein expression system. But the BEVS is limited by death and lysis of infected cells, which stops protein expression. This results in decreased productivity levels and higher production costs to generate recombinant proteins. The P-vank-1 vankyrin protein has been shown to protect Sf9 insect cells from apoptosis. Thus the expression of P-vank-1 allows insect cells to live longer and produce more protein—including intracellular, secreted, processed, and toxic proteins
Kendra Steele, Ph.D., Senior Research Scientist, ParaTechs

2:15
Case Study
Regeneron's FASTR®V2 Platform for bispecific Antibody Cell Line Development
FACS-based autologous secretion trap (FASTR®) is one of Regeneron's technology platforms used for CHO cell line development. FASTR® is a quantitative cell surface display technology that utilizes FACS sorting to enrich and isolate stable high producing cell lines. However, the expression of bispecific antibodies presents special challenges; Regeneron's bispecific antibodies comprise two different heavy chains and one common light chain, and the coordinated expression of the 3 genes required for optimized expression is unique to each bispecific molecule. We have modified the FASTR® platform (FASTR®V2) to enable the isolation of CHO cell lines expressing the highest levels of bispecific antibodies.
Dipali Deshpande, Ph.D., Senior Staff Scientist, Protein Expression Sciences, Regeneron Pharmaceuticals, Inc

3:00
Networking Refreshment Break in Poster & Exhibit Hall

Manufacturing Assessment Strategies

3:30
Panel Discussion
We wrap the day up with insights from a panel of expert scientists and researchers who share their insights, techniques, and strategies on manufacturing assessment.
Moderator:
Duncan Mcvey, Principal Scientist, Bristol-Myers Squibb
Panelists:
Rodney Combs, M.S., Associate Research Fellow, Bioprocess R&D, Culture Process Development, World Wide Pharmaceutical Sciences, Pfizer Inc.
Xiangguo Qiu, MD, Head, Vaccine Development & Antiviral Therapy, Special Pathogens Program, National Microbiology Laboratory, Public Health Agency of Canada
Marcio Voloch, Ph.D., VP, Biologics Process Development, Momenta Pharmaceuticals, Inc
David C. James, Ph.D., Professor, Bioprocess Engineering, University of Sheffield

4:30
Conference Ends

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