Gale E. Smith, PhD

SVP, Discovery and Pre-clinical Research,
Chief Scientist

Novavax, Inc.

Baculovirus Technology Produced SARS-CoV-2 Spike Protein Vaccine Induces Broad, High Affinity and Durable Protective Immunity

Bio

Nikolai Khramtsov, PhD

Head of Molecular Biology & Upstream Development

Protein Sciences Corporation, A Sanofi Company

Kyriacos Mitrophanous, PhD

Chief Scientific Officer

Oxford BioMedica plc

Bas van de Waterbeemd, PhD

Director Biological Starting Materials

uniQure N.V.

Christopher Nguyen, PhD

Scientist II

Voyager Therapeutics

Cenk Sumen, PhD

Chief Scientific Officer

MaxCyte Inc.

Bio

Ta-Chun Hang, PhD

Director of Biology

Kytopen Corp

Non-Viral Transfection

Bio

Arunava Steven Banerjee

Founder and CEO

NExTNet Inc.

Bio

Yashvinder Sabharwal, PhD

Co-founder & CEO

QbDVision, Inc.

Digital Strategies for Biotech Product Development and Lifecycle Management

Abstract Bio

Robert D. Possee, PhD

CEO

Oxford Expression Technologies

Bio

Marc G. Aucoin, PhD

Professor and Associate Chair, Operations — Department of Chemical Engineering

University of Waterloo

Bio

Nico Lingg, PhD

Senior Scientist

Austrian Centre of Industrial Biotechnology GmbH

Baculovirus Expression Technology for the Production of Virus-like Particles as Vaccine Candidates

Abstract Bio

Johannes Grillari, PhD

Director, Group Leader — Austrian Cluster for Tissue Regeneration

LBG Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with AUVA (LBI)

Exosomes

Dominic Esposito, PhD

Director, Protein Expression Laboratory

Frederick National Laboratory for Cancer Research (FNLCR)

Novel Technologies to Improve Insect Cell Production of Multiprotein Complexes

Abstract Bio

AntĂłnio M. M. RoldĂŁo, PhD

Head of Cell-Based Vaccines Development Lab and Coordinator of Late-Stage R&D Bioproduction Unit

Instituto de Biologia Experimental e TecnolĂłgica (iBET)

John M. Baust, PhD

President and Lead Scientist

CPSI Biotech

Improving Cell Recovery Following Cryopreservation: Incorporating Molecular and Device-Based Strategies

Bio

John Paul Tomtishen, III

Vice President of Operations — Cell Therapy Solutions

Cellares Inc.

Bio

Horst Ruppach, PhD

Executive Director Scientific and Portfolio — Biologics Solution

Charles River Laboratories

Viral Safety Testing Strategies for Advanced Therapy Medicinal Products

Abstract Bio

Gillian Payne, PhD

Vice President, Analytical Development

Carbon Biosciences

Analytical Development

Stephen Sofen, PhD

Chief Technical Officer

Abata Therapeutics

Regulatory T-cells

Pramod Pantha, PhD

Postdoctoral Research Scientist

Louisiana State University

Genomics Research on Baculovirus Infections in Fall Army Worm

Nancy Sajjadi

Founder and Principal Consultant

Sajjadi Consulting

Using an Equivalence Approach to Establish Lot Release Limits for Vector Dose During Pre-Clinical Studies and Early Phase Clinical Trials

Abstract Bio

Jeffery N. Odum

Practice Leader – ATMP and Biologics

Genesis AEC

Process Closure: The Impact on the Manufacturing Risk, Flexibility, and Facility Design for ATMPs

Abstract Bio

Vladimir Slepushkin, MD, PhD

Chief Technology Officer

MedTherapy Biotechnology Incorporated

Progress and Challenges in Manufacturing of Lentiviral Vectors

Abstract Bio

David L. Hermanson, PhD

Senior Manager of R&D Applications

Bio-Techne

TcBuster Transposon System: Non-Viral Gene Engineering of Cellular Therapies

Abstract Bio

Alden Ladd

Associate Director

Beam Therapeutics

Cell Product Process Development

Maria A. Croyle, PhD

Glaxo Wellcome Endowed Professor of Pharmaceutics — Department of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy

University of Texas at Austin

Stabilization of Biologic Drugs Within a Film Matrix

Benjamin A. Clarke, PhD

Senior Scientist II

US Pharmacopeial Convention (USP)

Assays for Cell Therapy Products and Raw Material Qualification

Bio

Nicholas DiGioia

Manager, CMC Process Development

LogicBio Therapeutics

Optimized AAV Manufacturing Process

Lise Abiven, PhD

Head of Business Development

IVETh Expertise Facility

An Expertise Core Facility for Multimodal Characterization of Extracellular Vesicles for Therapeutic and Diagnostic Purposes

Technology Workshop — Avid Bioservices

https://avidbio.com/

Technology Workshop — GenScript ProBio

https://www.genscriptprobio.com/

Technology Workshop — ElevateBio

https://www.elevate.bio/

Technology Workshop — Thermo Fisher Scientific

https://www.thermofisher.com/

Viral Vectors & Vaccines

Technology Workshop — OXGENE, a WuXi Advanced Therapies company

https://www.wuxiapptec.com/

Technology Workshop — Thermo Fisher Scientific

https://www.thermofisher.com/

Cellular Therapies

Technology Workshop — Gyros US Inc.

https://www.gyrosproteintechnologies.com/

Technology Workshop — Charles River

http://www.criver.com

Gale E. Smith, PhD

Gale Smith, PhD is the SVP, Discovery and Pre-clinical Research, Chief Scientist at Novavax, Inc. in Gaitherburg, Maryland. Dr. Smith leads a team of scientists responsible for the design and scientific direction of programs for vaccine development against pre-pandemic influenza, seasonal influenza, COVID-19, SARS, MERS, Ebola, and other infectious diseases. He leads the development of an influenza quadrivalent nanoparticle vaccine that successfully completed a Phase 3 licensing trail and demonstrated broadened protective responses, and met all endpoints required for approval. Currently, Dr. Smith also leads the scientific team that developed a SARS-CoV-2 spike nanoparticle COVID-19 vaccine proven to be well tolerated and highly protective in Phase 3 human trials that are ongoing in Europe, Africa, and North America. Dr. Smith received a PhD in Microbiology from Texas A&M University where he co-invented the BEVS baculovirus insect cell expression vector system, and holds a number of patents including one for the first recombinant influenza vaccine, Flublok™.

REV 100322
Cenk Sumen, PhD

Cenk Sumen, PhD is Chief Scientific Officer at MaxCyte, Inc., and is also Adjunct Professor at NYU Tandon School of Engineering. Most recently, Cenk was Chief Technology Officer at Stemson Therapeutics. Prior to this role, he was Director of Business Development at Thermo Fisher for the BioProduction Division. Other prior positions included Senior Business Development Manager at Hitachi Chemical supporting Cell Therapy Manufacturing, Consulting, and Process Development; Business Development Manager at Perkin Elmer where he supported PerkinElmer’s Drug Discovery Services business; Technical Sales Specialist at STEMCELL Technologies, where he provided technical consultative sales for stem cell culture and differentiation systems; and Technical Consultant, Sales and Marketing at Life Technologies, where he served as scientific, strategic, sales, and marketing consultant for the Dynabeads technology platform based in Norway. Cenk received his BS in Biology from MIT, and a PhD in Microbiology and Immunology from Stanford University. He was also a Cancer Research Institute Fellow at Memorial Sloan-Kettering Cancer Center for two years with Nobel Prize winner James P. Allison.

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Ta-Chun Hang, PhD

Ta-Chun Hang has worked in early development through commercial manufacturing for biologics and cell therapies, including supporting regulatory activities as well as heading pilot plant operations. He has combined his breadth of knowledge and expertise to drive innovation and novel approaches in process development. Ta-Chun completed two bachelor’s degrees (Biomedical Engineering, Human Physiology) from the University of Minnesota and a PhD in Biological Engineering from MIT. Currently, as the Director of Biology at Kytopen, Ta-Chun leads efforts in characterizing biological understanding and process development applications of Kytopen’s proprietary transfection technology platform.

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Arunava Steven Banerjee

Steven Banerjee founded NExTNet Inc. in late 2020 as a serial entrepreneur. His first startup, Mekonos is now a very successful biotechnology company backed by world-class investors — pioneering cell and gene editing and engineering platforms for different diseases. He is also an advisor to a promising clean energy company, Lumen Energy. Steven lived on the East Coast and in New Zealand in his earlier years. He earned his Mechanical Engineering degree from the University of Canterbury and got his grad school training at UC Berkeley. Steven also did cutting edge research at IBM Almaden and the Lawrence Berkeley National Lab. He currently lives in San Mateo, California.

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Digital Strategies for Biotech Product Development and Lifecycle Management

The concepts of product lifecycle management are typically associated with products that are in commercial manufacturing. As the innovations in therapeutic modalities gain momentum, the associated manufacturing processes are also increasing in complexity and driving increased scrutiny from regulators. The recent FDA guidance documents for gene therapy, CAR T-cells, and genome editing are asking for a more detailed analysis of the CMC program as early as IND submission. To manage this increased scrutiny earlier in development, lifecycle management principles need to be applied to ensure the creation of robust manufacturing processes underpinned by holistic control strategies and justified using an integrated knowledge base. The successful implementation of strategies for product development and lifecycle management of these complex CMC workstreams requires a new generation of data-centric, digital technologies built on FAIR (findable, accessible, interoperable, and reusable) principles to integrate knowledge and promote a strong culture of data governance and integrity. For biotech specifically, the principles of quality-by-design, which are intertwined with the recommendations of the ICH guidances, provide a familiar framework of best practices recognized by regulatory agencies internationally for the development of drug products over the entire lifecycle. Embedding these frameworks within the workflows of data-centric technologies provides the capability to create highly contextualized data sets that will support robust process development over the entire lifecycle to ensure that novel development programs can meet the increased scrutiny from regulators.

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Yashvinder Sabharwal, PhD

Yash Sabharwal is co-founder, President, and CEO of QbDVision, Inc. He is a successful serial entrepreneur with over 20 years of experience in the life science industry. He was previously co-founder and Chief Operating Officer at Xeris Pharmaceuticals. It was in this role that he crafted the vision for the development of the QbDVision platform. Yash has a BS in Optics from the University of Rochester and a MS and PhD in Optical Sciences from the University of Arizona.

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Robert D. Possee, PhD

Robert Possee received his PhD from the University of Warwick, UK after working on influenza viruses. He joined the Institute of Virology (now Centre for Ecology and Hydrology [CEH]), Oxford in 1981 to develop baculoviruses as biopesticides and, subsequently, their further application as expression vectors. Much of his early work in this latter area concerned the structure and function of the baculovirus gene promoters. His group also published the complete sequence of the Autographa californica nucleopolyhedrovirus (AcMNPV) in 1994. In parallel with this work, genetically modified variants of AcMNPV were developed containing genes encoding insecticidal proteins, which were subsequently tested in small scale field trials in Oxford. In the 1990’s his group also developed the linear DNA method for making recombinant baculoviruses, which was marketed under various guises but most commonly as BaculoGold or BacPAK6. More recently, working with Professor Linda King at Oxford Brookes University, UK, the flashBAC™ system for making virus recombinants was developed. This technology, together with a custom service for recombinant protein production, resulted in the founding of Oxford Expression Technologies (OET) Ltd in 2007. In March 2014 he left CEH after 32 years and began working full time with OET to continue the development of the baculovirus expression system.

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Marc G. Aucoin, PhD

Marc Aucoin is a Professor and Associate Chair, Operations in the Department of Chemical Engineering at the University of Waterloo (Waterloo, Ontario, Canada). Prior to becoming a faculty member, he was a Technical Officer at the Biotechnology Research Institute at the National Research Council of Canada. His research interests include developing robust scalable production processes for complex biologics in animal cell culture using a combination of process and genetic strategies.

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Baculovirus Expression Technology for the Production of Virus-like Particles as Vaccine Candidates

Virus-like particles (VLPs) are attractive formats for gene therapy, cancer therapy, and vaccines. As vaccine candidates, they combine the safety of recombinant protein-based products with the efficacy of whole virus structures. Enveloped VLPs require an outer membrane, making their production more challenging than pure, protein-based VLPs. The baculovirus expression technology allows for facile production of enveloped VLPs through budding. Crucial factors determining yield and quality are cell line, choice of capsid protein, and production process design. The bioprocessing of these bionanoparticles is challenging due to the presence of other particulate impurities such as exosomes, chromatin, and other vesicles, which necessitates high-resolution methods for separation. Separation of these particles can be achieved by ultracentrifugation, but scale-up of this method is challenging. Functionalized fiber materials possess optimal features to separate nanoparticles from each other and from process-related impurities such as host cell proteins and small host cell DNA. The fiber chromatography approach is particularly attractive, as the technology is readily scalable from laboratory to commercial manufacturing scale and compares favorably to other methods in regards to productivity and capacity. Additionally, the fiber matrix can be both sterilized and sanitized using standard industry methods, making it suitable for bioburden reduction and for aseptic processing.

REV 113022
Nico Lingg, PhD

Nico Lingg is a Senior Scientist at the Austrian Centre of Industrial Biotechnology and at the Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU). He spent two years at the Bioprocessing Technology Institute in Singapore. His research focuses on the design of platform downstream processes in bioprocess engineering. The main applications are the production and purification of biomacromolecules as biopharmaceuticals. This includes peptides, proteins, and bionanoparticles from various sources such as microbial fermentation, cell culture, or human plasma. His research interests are in downstream unit operations and characterization of biomacromolecules. The overall vision is to have standardized processes that can generically be applied for whole classes of potential products.

REV 113022
Novel Technologies to Improve Insect Cell Production of Multiprotein Complexes

Current advances in structural biology, highlighted by the advent of high-resolution CryoEM studies, now permit the elucidation of structures of vital complexes of proteins previously not possible. The generation of well-behaved, high-yield complexes of a variety of proteins remains a major obstacle in structural biology of vital drug discovery targets. To improve the potential to isolate functional multiprotein complexes, we have developed a variety of technologies including combinatorial cloning, multi-protein coexpression, and elucidation of specific chaperone/accessory proteins. Taken together, these methods have allowed us to determine the structure of a variety of protein complexes essential for our early-stage drug discovery efforts.

REV 111522
Dominic Esposito, PhD

Dr. Esposito is the Director of the Protein Expression Laboratory (PEL) at the Frederick National Laboratory for Cancer Research. The PEL produces proteins for structural biology and drug discovery efforts and invents and develops new technologies for protein expression and production. Dr. Esposito received his B.A. in Chemistry from La Salle University in Philadelphia, and his Ph.D. in Biochemistry from the Johns Hopkins University.

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John M. Baust, PhD

John M. Baust, Ph.D. is the founder of CPSI Biotech. Dr. Baust has over 20 years’ experience in research and medical device development. Dr. Baust is a recognized innovator and entrepreneur in cryomedicine and a pioneer in the area of molecular mechanisms of cell death and low temperature stress. Dr. Baust has published over 100 papers, reviews, book chapters, abstracts and over 75 patents in the area of the low temperature biology and has been instrumental in the advancement of the field into the molecular biological era focusing on signal transduction and apoptosis. Dr. Baust is credited with the discovery of cryopreservation-induced delayed-onset cell death. He has led the developed numerous medical devices, including cryoablation devices for the treatment of cancer and cardiac arrhythmias as well as spearheading the development of the SmartThaw device for improved cell and tissue cryopreservation. Baust also remains highly active in the study of the cell-molecular actions of cryoablation. These efforts have resulted in the identification of a significant molecular stress response component to freezing injury which is responsible for the differential sensitivity of various cancers to ablation. As an entrepreneur, Dr. Baust has founded four biotech and medtech companies. He was also on the founding team of BioLife Solutions, Inc, invented CryoStor, and was involved with the commercialization of CryoStor and HTS-FRS. Dr. Baust serves on the editorial board of Biopreservation and Biobanking as well as serving as a reviewer for other scientific journals, co-Edited the book Advances in Biopreservation, and is a board member for the Society for Cryobiology. Dr. Baust completed his studies at Cornell University, Binghamton University, and Harvard Medical School.

REV 112322
John Paul Tomtishen, III

John Tomtishen is Vice President of Operations at Cellares. He has more than 10 years of experience in cell and gene therapies, biologics, and vaccines, with diverse roles in Business Operations, CMC/Technical Operations, Supply Chain, Engineering/Facilities, and Operational Excellence. John served as the Site Managing Director at Legend Biotech’s corporate headquarters. He supported the clinical development and BLA filing of Ciltacabtagene autoleucel (Cilta-cel) in collaboration with Janssen Pharmaceuticals. John also worked for Novartis Pharmaceuticals within Cell and Gene Technical Development & Manufacturing. John had an integral role in the filing and approval of the first CAR T-cell BLA, Kymriah™ (tisagenlecleucel).

REV 092322
Viral Safety Testing Strategies for Advanced Therapy Medicinal Products

Viral contamination is an inherent risk in all biopharmaceuticals. Even though viral safety strategies were developed in the early 1990s and detailed in different regulatory guidelines, viral contamination remains a risk. The identification of porcine circovirus contamination in a marketed vaccine in 2010 indicated the ongoing risk despite viral safety experience accumulated over a period of more than 20 years. The development of new product modalities like viral vector-based products, oncolytic viruses, cell therapy products, etc. requires a review of existing viral safety strategies. In fact, the risk has significantly increased with the use of a broader range of biological source and raw materials and the speed with which such products are brought into the clinic. This presentation will give an update on the virus risks and advanced tools to mitigate risk from the earliest time point to ensure patient safety and business continuity.

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Horst Ruppach, PhD

Dr. Horst Ruppach studied chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV) at the Georg Speyer House in Frankfurt. He has 25 years of experience in the field of virology. His scientific, technical, and regulatory expertise is in virus safety testing and virus/prion clearance studies for any kind of biopharmaceutical including cell and gene therapy products. By expanding his expertise to all analytical characterization and testing required for biologics entering the clinical phase he adopted a scientific leadership role at Charles River Biologics in 2019. His focus is now on coordinating global development through a newly instituted Global Scientific Governance Group and actively managing Charles River Biologics’ portfolio.

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Using an Equivalence Approach to Establish Lot Release Limits for Vector Dose During Pre-Clinical Studies and Early Phase Clinical Trials

Pre-clinical studies and clinical trials conducted to establish the minimum effective dose and the maximum tolerated dose of a viral vector assume, from a statistical standpoint, that there is no error in the assigned dose values. Half log dose escalations are common and can be achieved by varying volume from a single batch or by manufacturing multiple vector batches with approximately half log titer differences. The latter approach is necessary when there are constraints on the volume of vector that can be delivered. The amount required to achieve a dose target level is typically determined using the mean measured titer value for the vector batches being used. Although it is not possible to make error-free measurements of vector dose, the goal of assay development and optimization is to minimize measurement uncertainty. Deciding how many titer values should be combined to yield the label concentration for a batch is driven by how much error can be tolerated and whether a batch may be useable for dose escalation based on the volume constraints imposed by the titer. This presentation will include a brief overview of a lot-release equivalence model published in 2020 and provides additional guidance to address select issues identified with its reduction to practice in the field. A case study will be used to show how setting equivalence bounds and selecting release limits on reported values are balanced against the differential burdens of achieving consistency in manufacture of vector batches and reducing measurement uncertainty.

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Nancy Sajjadi

Nancy Sajjadi, MSc is Founder and Principal Consultant at Sajjadi Consulting. She has over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research then joined a start-up company developing cell and gene therapies for infectious disease and cancer applications. Her responsibilities included research, assay development, and quality control. In 2000, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start her own consulting business. For over 20 years, Ms. Sajjadi has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities, and US government agencies. She has assisted clients in the development, implementation, and improvement of quality programs for a range of cutting-edge products and provides technical expertise in assay development, qualification, and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy and has served on five advisory panels for the United States Pharmacopeia (USP). She enjoys teaching introductory courses in bioassay design, development, and validation for non-statisticians. Her company has recently expanded services to include leadership development and executive coaching to guide organizations toward sustaining a culture of quality.

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Process Closure: The Impact on the Manufacturing Risk, Flexibility, and Facility Design for ATMPs

While the journey to define closed manufacturing systems for biologics has been 22 years in the making, its impact on the manufacturing of cell and gene therapy products has been immediate. The strategy organizations develop and implement around product protection must focus on process understanding driven by risk assessment for an evolving industry segment that has its roots in non-traditional GMP production. This presentation will identify the steps to design process closure, the current methods of implementation, the risk assessment tools to verify mitigation, and the impact on the facility attributes where flexibility is a primary driver in facility optimization. Case study references will be supplemented by recent regulatory and industry guidance, including International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and BioPhorum guidelines and training-for-industry. Topics will include equipment selection, scale-out strategies, multi-platform strategies, and future-proofing assets.

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Jeffery N. Odum

Jeff Odum, CPIP, is a globally recognized SME in Biomanufacturing Facilities who has over 30 years of management experience in the design, construction, and commissioning of facilities in the biotechnology and pharmaceutical industries. A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored over 50 published articles and four industry reference books on subjects related to project management, GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next-generation facility design, bioprocess manufacturing, project management, and GMP compliance. Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is the serving Chair of the ISPE Global Biotechnology Community of Practice, and a contributing author to numerous industry baseline and reference guides focused on ATMP and biotechnology manufacturing, process development, project management, and commissioning and qualification. He is a member of the ISPE technical training faculty and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program. He has led training efforts in 15 countries in over 100 sessions, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.

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Progress and Challenges in Manufacturing of Lentiviral Vectors

As interest increases in the use of lentiviral vectors for gene, cell, and cancer therapies, scalable and affordable strategies are required to generate high-quality lentiviral vectors for both clinical trials and commercial manufacturing. MedTherapy Biotechnology has a mission to reduce costs of CAR-T cell manufacturing, including the costs for producing lentiviral vectors. Several current and potential future strategies will be reviewed and analyzed.

REV 111422
Vladimir Slepushkin, MD, PhD

Dr. Vladimir Slepushkin is Chief Technology Officer at MedTherapy Biotechnology. He is leading all functions associated with the manufacturing of CAR-T cells and viral vectors. Previously, he was Executive Director of Vector Technology at Autolus Therapeutics, leading process development for the manufacturing of lentivirus vectors in suspension cell culture, guiding assay development to support process development for lentiviral vectors, managing CMO for GMP vector production, and T-cell processing. Before that, Dr. Slepushkin was directing research vector core, and providing lentiviral, retroviral, and AAV vectors for Kite Pharma. Vladimir proved successful in developing novel, high-quality products by managing diverse technical groups and cross-functional teams, developing first-in-class clinical product from scratch, including facilities, equipment, manufacturing process, quality systems, regulatory CMC submissions, and clinical trials design.

He has proven expertise in technically understanding and leading the development and improvement of cell culture and purification processes and operations and analytical methods, adhering to customer, regulatory, safety and environmental requirements and guidelines. Vladimir is experienced in identifying and resolving regulatory and manufacturing technical problems, as well as intellectual property assessment and licensing. He has authored sixty-one scientific papers in peer-reviewed journals and is an author on fourteen patents and patent applications.

REV 111422
TcBuster Transposon System: Non-Viral Gene Engineering of Cellular Therapies

Novel methods for the introduction of therapeutic cargo are needed as cellular therapies become more complex. TcBuster is a transposon system that non-virally integrates cargo randomly in the genome by co-transfecting plasmid DNA, encoding the gene(s) of interest, and mRNA, encoding the transposase into cells. This provides many benefits, including consistent lot-to-lot manufacturing of plasmid DNA and mRNA, safer integration profile, lower cost of goods, and most importantly the ability to insert larger cargo, encoding multiple genes to create more efficacious therapies. TcBuster has similar integration efficiency to lentivirus when expressing a single CAR (50-60%), while maintaining >30% stable integration when working with multi-cistronic vectors encoding up 4 separate proteins. Finally, TcBuster is currently being used in the development of multiple cellular therapies destined for the clinic.

REV 111522
David L. Hermanson, PhD

David is currently the Senior Manager or R&D Applications for Bio-Techne, focusing on developing cell therapy workflows. He has worked with transposon systems developing cell therapies for 10+ years, beginning in his post-doc, then with Poseida Therapeutics, B-MoGen Biotechnologies, and now Bio-Techne, working on iPSC derived NK cells, CAR T cell, and CAR NK cell therapies.

REV 111522
Benjamin A. Clarke, PhD

Ben Clarke received his Ph.D. in Cellular Biology from Cornell University in 2012 for his investigation of mammalian membrane biology and lipid remodeling. He has been at USP since 2020, where he is the scientific liaison for the Expert Committee on Advanced Therapies. He provides scientific support for USP’s portfolio of biological standards, including reference standards for cell therapy, gene therapy, monoclonal antibodies, and vaccines. Before joining USP, Ben developed analytical bioassays for GSK vaccines, working with a novel self-amplifying mRNA platform and a recombinant protein-based respiratory syncytial virus vaccine for older adults. Previously, at a Postdoctoral position with the National Institute of Health, he investigated sphingolipid biology through CRISPR/Cas9 genome edited mouse models. He earned his B.S. in Biochemistry at the Pennsylvania State University while working with protein expression systems for structural biology.

REV 111722