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PROGRAM CHAIRS: PROGRAM CHAIRS: PROGRAM CHAIRS:
Manuel J.T. Carrondo, PhD
Instituto de Biologia Experimental e Tecnológica (iBET)
Clifton E. McPherson, PhD
Protein Sciences Corporation
Otto-Wilhelm Merten, PhD
Généthon
Amine A. Kamen, PhD
McGill University
Martin A. Giedlin, PhD
Novartis Pharmaceuticals Corporation
Gary K. Lee, PhD
Sangamo BioSciences, Inc.

Dominic Esposito, PhD
Director, Protein Expression Laboratory
Frederick National Laboratory for Cancer Research
The Complete Genome Sequence of a Trichoplusia ni Cell Line, Tni-FNL

Abstract

We have determined the complete genome sequence of a Trichoplusia ni cell line, Tni-FNL, to the highest quality and completeness of any lepidopteran organism sequenced to date. We will present data on the methodology used to map the genomic sequence along with bioinformatic analysis discussing similarities and differences among the sequenced lepidopteran hosts. In addition, we will discuss some of the unique characteristics of this cell line which may be responsible for its ability to produce higher levels of recombinant proteins than other cell lines, including commercially available lines such as High Five.

Biography

Dr. Esposito is currently the Director of the Protein Expression Laboratory (PEL) at the Frederick National Laboratory for Cancer Research (FNL) in Maryland. The PEL primarily generates DNA and protein reagents for the NCI national mission to target KRAS-driven cancers, as well as supporting NCI and NIH intramural investigators in production of difficult proteins. Prior to his role as director, Dr. Esposito led the Clone Optimization Group in the PEL for nine years and was responsible for the generation of over 15,000 expression clones, 400 new expression vectors, and several technological innovations in protein expression. Dr. Esposito received his BA in Chemistry at La Salle University in Philadelphia, and his PhD in Biochemistry at the Johns Hopkins University Bloomberg School. Dr. Esposito previously worked for Life Technologies, where he helped to develop the Gateway recombinational cloning system.

Giuliana Vallanti, PhD
Development & Quality Control Director, MolMed S.p.A.
Development and GMP Production of Large-Scale Lentiviral/Retroviral Vectors
and Genetically Modified Hematopoietic Stem Cells and T-Cells

Abstract

MolMed is a medical biotechnology company focused on research, development, and clinical validation of innovative therapies to treat cancer and rare genetic diseases. MolMed's portfolio in cell and gene therapy includes anti-tumor drugs in clinical and preclinical development:
- Zalmoxis® (TK) is a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, currently in Phase III in high-risk acute leukaemia and approved by European Medicines Agency (EMA) for conditional marketing authorization;
- CAR-CD44v6, an immuno-gene therapy project potentially effective for many haematological malignancies and several epithelial tumours, currently in preclinical development.

Moreover, MolMed offers high level expertise to develop, perform, and validate custom studies, optimize and scale-up manufacturing projects, devise innovative testing procedures, and address the unique test specifications required for novel therapies. In order to meet vectors manufacturing demands for both clinical and commercial phases, MolMed is developing modular innovative processes (24 L, 48 L, 200 L) in cell factories and in disposable bioreactors that permit an increase in lentiviral/retroviral (LV/RV) vector productivity, reducing cost of goods and preserving high vectors quality. MolMed is also investigating LV production using suspension cell lines cultured in the absence of animal-derived components to ensure a higher level of safety and unlimited possibilities for scale-up. MolMed is improving hematopoietic stem cell and T-cell production processes in order to develop closed systems with a high level of cell transduction, lower number of manipulations to increase sterility assurance levels, and process reproducibility.

Biography

Giuliana Vallanti is Development and Quality Control Director and Qualified Person at MolMed. She joined MolMed in 2005 and worked with growing responsibilities in the development and quality control units, contributing to the development of processes and assays in the cell and gene therapy field. She has primary experience in the development and industrialization of T- and haematopoietic cell transduction processes with lentiviral and retroviral vectors. She also worked on the development of GMP processes for large-scale vector production and purification. She holds a degree in biology from Università degli Studi di Urbino and a PhD in biochemical and pharmacological methods with a study on lentiviral vectors for gene therapy anti HIV-1.

Steven E. Pincus, PhD
Associate Vice President Virology and Analytical Methods Development
FUJIFILM Diosynth Biotechnologies Texas, LLC
A Suspension Vero Cell Line for Production of Viral Vaccines and Viral Therapeutics

Abstract

As the acceptance of viral vectors as a delivery system for therapeutics grows, biomanufacturers are looking for an alternative to the classical adherent cell production models. Adherent cell lines such as Vero and Madin Darby canine kidney (MDCK) are licensed for vaccine production, but they require large volumes of media, specialized large-scale adherent culture vessels with a large working footprint, and the equipment to support them. Suspension cell lines, such as Chinese hamster ovary (CHO) and HEK-293 are licensed for antibody production, but have not yet been licensed for vaccine production. A mammalian cell line that can simultaneously grow in suspension, support many types of viruses and viral vectors, and produce high virus titers would be of great value for production of vaccines and viral therapeutics.

Fujifilm Diosynth Biotechnologies Texas (FDBT) is a contract development and manufacturing organization that specializes in the production of viral therapeutics and vaccines. We have employed the use of a Vero cell line, which is permissive to a wide array of viruses, to create a platform for virus and viral vector growth. We have adapted this adherent Vero cell line to a serum-free, fast growing suspension culture. We have evaluated the ability of the adherent and suspension cell lines to amplify viruses and viral vectors such as influenza virus, adeno-associated virus, and adenovirus. This proprietary suspension Vero line will be an excellent asset to viral vector and vaccine manufacturing, as it will allow the growth of commonly difficult-to-scale vectors. FDBT has also developed a wide variety of analytical methods to evaluate the growth of virus and viral vectors which are commonly used to support the numerous manufacturing stages of vaccine production. These include analyses designed to identify (PCR, ELISA), quantify (FACS, immunostaining, plaque assay), and verify the purity (HPLC, SDS-PAGE/Western, ELISA) of our products.

Biography

Steven Pincus is Associate Vice President of Virology and Analytical Development at Fujifilm Diosynth Biotechnologies Texas where he leads teams involved in process development and analytical development for client driven programs in viral therapeutics and vaccines. He obtained his BS and PhD in Biochemistry from the State University of New York at Buffalo. His PhD thesis project involved studies on the mechanism of adenovirus DNA replication, and he gained experience growing, purifying, and titering multiple adenovirus serotypes. He obtained his postdoctoral training in the microbiology department at the State University of New York at Stony Brook under an NIH fellowship studying inhibitors of picornavirus replication, and gained experience in the growth, purification, and titration of poliovirus and the growth of other picornaviruses.

He then joined Virogenetics where he was Senior Scientist and Platform Leader in Molecular Biology and Microbiology. At Virogenetics he was involved in the development of highly attenuated poxvirus vaccine vectors (NYVAC, ALVAC, TROVAC) and developed vaccine candidates for measles virus, flaviviruses (JEV, dengue, yellow fever), human cytomegalovirus, and therapeutic vaccines against several cancers along with development of molecular assays necessary for releasing clinical lots. At Elusys Therapeutics he was Senior Director Virology and Animal Biology and received $1.6 million NIH grant funding to investigate the use of the Elusys antibody heteroplymer technology as a therapeutic for vaccinia vaccination complications. He developed animal models and release assays for heteropolymer clinical trials and supported the development of an anthrax anti-toxin monoclonal that is funded by the Biomedical Advanced Research and Development Authority (BARDA). He then joined Novavax, Inc., a biotech focused on the development of vaccines against influenza and respiratory syncytial virus (RSV), based on virus-like particle (VLP) platform vaccine technology. There he was responsible for analytical development, quality control and quality assurance, and recombinant baculovirus production. He was a key member of the team that secured a contract award valued at up to $179 million by BARDA for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. He has consulted for several companies in the areas of assay development, transfer, qualification, and validation for monoclonal antibody and vaccine projects.

Christoph Geisler, PhD
Chief Research Scientist, GlycoBac LLC
Adventitious Viruses Contaminating Insect Cell Lines

Abstract

Starting in the late 1970s, a wide variety of viruses had been found to contaminate insect cell lines. Surprisingly, adventitious viruses contaminating insect cell lines routinely used for recombinant protein and AAV production were not discovered until 2007 (High FiveTM) and 2014 (Sf9). These discoveries raised important questions regarding the biosafety of therapeutics produced in this platform. In this talk, I will discuss viruses that can contaminate insect cell lines, including several relatively little-known ones. As most persistent viral infections of insect cell lines were discovered serendipitously, I will also discuss how these viruses were discovered as well as detection methods that can be used to probe for viral contamination. Finally, I will present new virus-free insect cell lines that have been developed as alternatives to contaminated cell lines, and to what extent these can serve as viable alternatives to their well-established, contaminated counterparts.

Biography

Christoph Geisler has worked in the baculovirus insect cell system since 2005. He has experience in both cell line development and baculoviral vector engineering, and specializes in the glycobiology of the system. Recently, he has developed new bioinformatics approaches to screen for adventitious viral contaminants in cell lines used to produce biopharmaceuticals.

Nicole Faust, PhD
Chief Scientific Officer, Cevec Pharmaceuticals GmbH
CAP-GT, a Platform Addressing the Production Challenge

Biography

Nicole Faust is Chief Scientific Officer and Managing Director at CEVEC Pharmaceuticals, overseeing the company´s activities in gene therapy vector production and recombinant glycoprotein expression. Over the last 18 years she has held scientific management positions with several biotech companies. Before joining CEVEC in 2011, she worked with Lonza as Director R&D combining her expertise in cell biology and gene transfer technology to develop cell-based assays. Prior to Lonza she was heading the Molecular Technology Department at Artemis/Taconic Biosciences, using site-specific recombination and gene editing technologies for the development of pharmaceutically relevant animal models. Nicole holds an MBA degree from Educatis University, Switzerland and she received her PhD in Molecular and Cell Biology from University of Freiburg and spent her postdoctoral period at EMBL, Heidelberg, where she worked on embryonic stem cells and cell differentiation within the hematopoietic system.

Ana Sofia Coroadinha, PhD
Head of Cell Line Development and Molecular Biotechnology Laboratory
Instituto de Biologia Experimental e Tecnológica (iBET)
Novel Stable Lentiviral Vector Producer Cells: Overcoming Viral Vector Cytotoxicity
Etienne Boutry
Director Bioprocess R&D Europe, Sanofi Pasteur SA
Challenges in Process Development and Industrialization of Live Virus Vaccine:
Dengue and Flavivirus Experience on a Vero Cell Line
Lesley Chan, PhD
Scientist II, Vector Process Development & Manufacturing, bluebird bio Inc.
The Development and Intensification of a
Lentiviral Vector Manufacturing Process Using Stable Cell Lines
Hanna P. Lesch, PhD
Research and Development Director, FinVector Vision Therapies OY
Large-Scale Production Work of Adenoviral, Lentiviral, and AAV Vectors
Charlotte Dyring, PhD
COO & Co-Founder, ExpreS2ion Biotechnologies
Nathalie A. Clément, PhD
Associate Director, PGTC Vector Core Laboratory, University of Florida
Christopher W. Kemp, PhD
President, Kempbio, Inc.
Helen Maunder, PhD
Principal Scientist, Oxford BioMedica plc
James J. Mule, PhD
Executive Vice President Applied Science
H. Lee Moffitt Cancer Center & Research Institute
Christine Le Bec, PhD
Head of Analytical Development, R&D, Généthon
Sergei Zolotukhin, PhD
Professor, Division of Cellular & Molecular Therapy, University of Florida
John T. Elliott
Cell Systems Science Group Leader, National Institute of Standards & Technology
David Hodl
President, Cell Processing Business Unit, SynGen Inc.
Gary K. Lee, PhD
Associate Director, Genome Editing, Sangamo BioSciences, Inc.
Kimberly Lounds-Foster
Corporate Vice President, Global Supply, Celgene Corporation

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