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.

2 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.

3 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.

4 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 12:00 noon AAV Capsids and Avoid Empty and Disrupted Particles Vironova AB.

5 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.

6 Lesch, PhD Durable Persistence in Solid Tumor Models Through Advanced Manufacturing Process Design FinVector Vision Therapies OY Avery D. 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.

7 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. 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.

8 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.

9 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. 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.

10 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.