Cellular Therapies – Program Chairs: Baculovirus ...

1 Viral Vectors & Vaccines Program Chairs: Cellular Therapies Program Chairs: Baculovirus Expression Technology Program Chairs: Otto-Wilhelm Merten, PhD G n thon Martin A. Giedlin, PhD Novartis Pharmaceuticals Corporation Manuel Carrondo, PhD Instituto de Biologia Amine A. Kamen, PhD McGill University Gary K. Lee, PhD Sangamo BioSciences, Inc. Experimental e Tecnol gica (iBET). Clifton E. McPherson, PhD Protein Sciences Corporation, A Sanofi Company SUNDAY MARCH 4, 2018. 3:00 pm 7:00 pm Welcome Reception and Registration in the Granby Ballroom Foyer, Third Floor MONDAY MARCH 5, 2018. 7:00 am 8:00 am Registration and Breakfast in the Granby Ballroom Foyer, Third Floor 8:00 am 8:30 am Meeting Overview in Momentum, Third Floor Viral Vectors & Vaccines Cellular Therapies Baculovirus Expression Technology Momentum, Third Floor Fusion, Third Floor Energy, Third Floor View Speaker Abstracts & Bios View Speaker Abstracts & Bios View Speaker Abstracts & Bios 8:30 am 9:15 am OneBac rAAV Scale-Up Production Platform with Serotype-Specific Successful Manufacturing of T-Cell Therapies : Challenges and The Complete Genome Sequence of a Trichoplusia ni Cell Line, Modulation of AAV Capsid Protein Stoichiometry Opportunities Tni-FNL.

2 Sergei Zolotukhin, PhD Cenk Sumen, PhD Dominic Esposito, PhD. University of Florida Hitachi Chemical Advanced Therapeutics Solutions, LLC Frederick National Laboratory for Cancer Research 9:15 am 10:00 am Biological Activity of Additional AAV Subpopulation in AAV Gene Cell Therapy: Islet Isolation and Transplant Quality Control Release Cervarix Vaccine: From Baculovirus Technology to the First Human Therapy Product Considerations BEVS-Based Vaccine Marian Bendik Francis Karanu, PhD Isabelle Knott, PhD. Shire Likarda, LLC GlaxoSmithKline Biologicals 10:00 am 10:30 am Morning Break in the Exhibit Area Technology Workshop Technology Workshop Technology Workshop SGS Vitrology Pending A Chemically-Defined Baculovirus -Based Expression System for 10:30 am 11:00 am Enhanced Protein Production in Sf9 Cells Thermo Fisher Scientific Technology Workshop Technology Workshop Technology Workshop Scaling Up and Industrializing the Production of Viral Vectors and Pending Laser Force Cytology: A Novel Technology for Rapid Quantification 11:00 am 11:30 am Cells for Therapeutic Use of Viral Infectivity and Label-Free Cellular Analysis Pall Life Sciences LumaCyte Technology Workshop Technology Workshop Technology Workshop Optimized Quantification Methods to Determine the Portion of Full Pending Pending 11:30 am 12.

3 00 noon AAV Capsids and Avoid Empty and Disrupted Particles Vironova AB. 12:00 noon 1:30 pm Lunch in the Exhibit Area (Poster Session from 1:00 1:30 pm). 1:30 pm 2:15 pm The Development and Intensification of a Lentiviral Vector CAR T-Cells with Non-Viral Gene-Editing Technology Towards Routine Manufacturing of Gene Therapy Drugs . Manufacturing Process Using Stable Cell Lines David L. Hermanson Requirements for Further Improvements Example: AAV. Lesley Chan, PhD Poseida Therapeutics, Inc. Otto-Wilhelm Merten, PhD. bluebird bio Inc. G n thon 2:15 pm 3:00 pm Viral Vector Manufacturing: Challenges and Solutions Enhancing CAR T-Cell Specificity for Malignancy and Maintaining Enabling Access to a Norovirus Virus-Like Particle-Based Vaccine Hanna P. Lesch, PhD Durable Persistence in Solid Tumor Models Through Advanced Manufacturing Process Design FinVector Vision Therapies OY Avery D.

4 Posey Jr., PhD Scot Shepard University of Pennsylvania Takeda Pharmaceuticals , Inc. 3:00 pm 3:30 pm Afternoon Break in the Exhibit Area 3:30 pm 4:15 pm Characterization of Stability-Indicating Assays for Viral Vectors Metabolomics: Enabling Understanding and Optimization of Bioprocess Engineering of Insect Cells for Pseudotyped VLP. Lawrence C. Thompson, PhD Bioprocesses and Immunotherapies Expression and Optimization Pfizer, Inc. Kendra Hightower, PhD Ant nio M. Roldao, PhD. Metabolon, Inc. Instituto de Biologia Experimental e Tecnol gica 4:15 pm 5:00 pm Analytical Strategies on Quantification of Adeno-Associated Virus Achieving High Quality Cell-Based Measurement: Application to Tweaking Baculovirus Expression Vectors to Stabilize Transgenes (AAV) Empty Capsids to Support Process Development Process Controls and Potency Assays and Polish Enveloped VLP Vaccines Wei-Chiang Chen, PhD John T.

5 Elliott Gorben P. Pijlman, PhD. Biogen National Institute of Standards & Technology Wageningen University Plenary Session in Momentum, Third Floor: Air Handling for Viral Vector Suites 5:00 pm 6:00 pm Christian D. Lynch FDA CBER, Mark F. Witcher, PhD NNE, and Kim L. Nelson, PhD CRB. 6:00 pm 8:00 pm Reception in the Exhibit Area 1. ISBioTech 8th Spring Meeting (continued): TUESDAY MARCH 6, 2018. Viral Vectors & Vaccines Cellular Therapies Baculovirus Expression Technology Momentum, Third Floor Fusion, Third Floor Energy, Third Floor 7:30 am 8:30 am Breakfast in the Exhibit Area 8:30 am 9:15 am Christine Le Bec, PhD High Throughput Identification of Naturally-Occurring T-Cell Simplifying Membrane Protein Purification: Introducing a G n thon Receptors with Therapeutic Potential Against Tumor-Associated, Fluorescent BEVS Protein System that Enhances Protein Production Viral, and Neoantigens and Greatly Simplifies Detergent Screening Adria Carbo, PhD Kendra Steele, PhD.

6 Adaptive Biotechnologies ParaTechs Corporation 9:15 am 10:00 am Many Ways Lead to Rome for Assessing the Genetic Stability of a Improving the Preservation of T-Cells Adventitious Viruses Contaminating Insect Cell Lines Viral Vector Chia-Hsing Pi Christoph Geisler, PhD. Pepijn Burgers, PhD University of Minnesota GlycoBac LLC. Janssen Vaccines & Prevention 10:00 am 10:30 am Morning Break in the Exhibit Area 10:30 am 11:15 am Novel Purification Process to Obtain Pure AAV Vectors of 1e+16 vg T-Cell Activation Co-Stimulatory Ligands on a Dissolvable Regulatory Updates and Using Virus-Like Particles to Inform in a Single Run of Conventional Ultracentrifuge Substrate to Modulate T-Cell Output Norovirus Vaccine Design Haifeng Chen, PhD Sean H. Kevlahan, PhD Robin Levis, PhD and Gabriel I. Parra, PhD. Virovek, Inc. Quad Technologies FDA CBER. 11:15 am 12:00 noon Scalable Lentiviral Vector Production Using Stable HEK293 Tam Soden, PhD Comparative Transcriptome Analysis of AcMNPV Infection in the Suspension Cells Kite Pharma, Inc.

7 Midgut of Host Insect Trichoplusia ni, and in a T. ni Cell Line Aziza P. Manceur, PhD Gary W. Blissard, PhD. National Research Council Canada Boyce Thompson Institute 12:00 noon 12:45 pm Testing Approaches for Viral Vectors Used in Gene Therapy: Novel Methods and Regulatory Expectations Leyla Diaz, PhD. MilliporeSigma BioReliance Services 12:45 pm 2:00 pm Lentivirus Reference Standard Working Group Meeting in Energy, Third Floor Free Afternoon with Recommended Group Activity: 12:45 pm 6:00 pm River Cruise on the Victory Rover and Admission to Nauticus and the Battleship Wisconsin 6:00 pm 9:00 pm Psychedelic Banquet at Half Moone featuring BJ Griffin & the Galaxy Groove WEDNESDAY MARCH 7, 2018. 7:30 am 8:30 am Breakfast in the Exhibit Area 8:30 am 9:15 am Challenges in Process Development and Industrialization of Live Chemically-Defined Culture Media for Advancing Cell Therapy Control Using BEVS: From Promoters to CRISPR.

8 Virus Vaccines: Dengue and Flavivirus Experience on a Vero Cell Technology Marc G. Aucoin, PhD. Line Jessie Ni, PhD University of Waterloo Etienne Boutry Irvine Scientific Sanofi Pasteur SA. 9:15 am 10:00 am Large-Scale Manufacturing of Clinical-Grade rAAV in an Academic The Role of Leukapheresis and Elutriation in Cell Immunotherapy HER2 Cancer Vaccine Optimization by Combining Drosophila S2. Setting: How Efficacy, Versatility, Space, and Cost Drive Process Manufacturing Insect Cell Manufacturing with a Novel VLP-Display Technology and Development Toward Sustainable Methods Joseph M. Roig Willem Wian A. de Jongh, PhD. Nathalie A. Cl ment, PhD Terumo BCT ExpreS2ion Biotechnologies University of Florida 10:00 am 10:30 am Morning Break in the Exhibit Area 10:30 am 11:15 am Novel Stable Lentiviral Vector Producer Cells: Overcoming Viral Engineered Pluripotent Cell-Derived NK Cells as a Cornerstone Progress on the Genome of the Spodoptera frugiperda Sf9 Cell Line Vector Cytotoxicity Approach for Off-the-Shelf Cancer Immunotherapy Arifa S.

9 Khan, PhD. Ana Sofia Coroadinha, PhD Bahram Bob Valamehr, PhD FDA CBER. Instituto de Biologia Experimental e Tecnol gica Fate Therapeutics, Inc. 11:15 am 12:00 noon Retroviral and Lentiviral Production in Disposable Bioreactor: Optimizing the CAR T-Cell Supply Chain rAAV Vector Development and Large-Scale Manufacturing Using Development and Scaling Up of Upstream and Downstream Kimberly Lounds-Foster BEVS Technology Process Steps Celgene Corporation Jacek Lubelski, PhD. Francesca Bellintani uniQure MolMed 12:00 noon 1:30 pm Lunch in the Exhibit Area (Poster Session from 1:00 1:30 pm). 1:30 pm 2:15 pm The Use of Automation in the Development of Lentiviral Vector Automated, Closed System Manufacturing of CAR T-Cells PEI-Mediated Transient Transfection of Insect Cells for the Packaging and Producer Cell Lines Philip Coelho Expression of Recombinant Proteins in Stirred-Tank Bioreactors Helen Maunder, PhD Thermogenesis Corp.

10 Christopher W. Kemp, PhD. Oxford BioMedica plc Kempbio, Inc. 2:15 pm 3:00 pm CAP-GT, a Platform Addressing the Production Challenge Sukhanya Jayachandra, PhD Biochemical and Biophysical Characterization of Adeno-Associated Nicole Faust, PhD FDA CBER Viruses Produced by Triple Transfection in HEK293 Cells and with Cevec Pharmaceuticals GmbH Insect Cells/ Baculovirus Expression System Eric Horowitz, PhD. Voyager Therapeutics 3:00 pm 3:30 pm Afternoon Break in the Exhibit Area 3:30 pm 4:15 pm Pushing the Boundaries of Adeno-Associated Virus Integrated, Closed System PAT Analytics for Advanced Auto Jamal Meghrous Characterization for Enhanced Product and Process Understanding Feedback Control of Critical Process Parameters Reactive Protein Sciences Corporation, A Sanofi Company Thomas Wesley Powers Analytics Pfizer, Inc. Dan Kopec Sartorius Stedim Biotech 4:15 pm 5:00 pm A Suspension Vero Cell Line for Production of Viral Vaccines and Linda L.