The production and commercialisation of advanced therapy medicinal products (ATMPs) such as lentiviral vectors present unique challenges in design, production, purification and quality control (QC) release testing when compared to traditional pharmaceutical compounds and even other biologics such as monoclonal antibodies.
Optimal production is heavily dependent on the concentration and ratios of the plasmid DNA components contributing to the transfection process. Improving titres can determine whether a new gene therapy product is commercially viable. A considerable amount of research is aimed at establishing the best titre and one of the ways to do this is by ensuring optimal transfection ratios that can improve the productivity or recovery of upstream/downstream platform processes.
Furthermore, many of the analytical methods employed require days or weeks to complete often with multi-step cell culture combined with quantitative readouts. Lengthy protocols, operator-to-operator variability and a heavy dependence on manual setup are common shortfalls.
Lab-based robotics and digital tools enable bench scientists to work more efficiently, generate more robust data and reduce time-to-insight. Automation in both research and good manufacturing practice (GMP)-regulated environments increases assay throughput, robustness, repeatability and reduces operator’s hands-on-time. Moreover, design of experiments (DoE) and multivariate systems optimisation helps identify optima at a speed that would be impossible using manual methods. Such cutting-edge ways of working help reduce time-to-market and deliver scalable, cost-effective, viral vector drug products.
Register for this webinar to explore how advanced robotics, digital tools and design of experiments are revolutionizing viral vector manufacturing, optimization and QC release testing.
Speakers
André Raposo, PhD, Director, Innovation Department, Oxford Biomedica
André Raposo, PhD, is a Director at OXB in the Innovation Department. He leads a group of scientists delivering cutting-edge research in the field of cell and gene therapy supported by computer-aided biology and high-throughput automation.
He has extensive experience in technology development, upstream process development, DoE strategies, analytical development, robotics and associated regulatory compliance. Prior to Oxford Biomedica, Dr. Raposo worked within the Transduction Sciences CGT Platform CMC at GSK. Dr. Raposo holds a PhD from the University of Oxford and specialized in the understanding of host restriction factors controlling HIV replication and the mechanisms leading to HIV persistence and latency during his postdoc at the University of California, San Francisco, and George Washington University, USA.
Gareth McCathie, PhD, Group Lead, Oxford Biomedica
Gareth McCathie, PhD, is a Group Lead at OXB in the Innovation Department. He is responsible for driving the implementation and continual improvement of lab automation and digital tools to enable bench scientists to work more efficiently, accelerate the delivery of results and ensure the robustness of data.
Gareth has 10 years of experience in analytical development, 7 of which were focussed specifically on automation and process efficiencies. He is proficient in the integration of robotics and automated data processing tools, assay development and method transfers, GxP-compliant validation and inter-disciplinary communication and change management.
Before transitioning to industry, Gareth earned his PhD from The University of Sheffield, where he investigated the molecular and cellular signaling processes in appendage regeneration.
Thomas Evans, Principal Scientist, Oxford Biomedica
Thomas Evans is a Principal Scientist at OXB in the Innovation Department. He specialises in data-driven modelling, statistical analysis and bioinformatics. He emphasises human-in-the-loop methods for optimisation, troubleshooting and characterisation, enabling automation throughout study design, execution, data analysis and reporting.
Tom has almost a decade experience carrying out DoE methods and is a keen proprietor of intensified, mechanistic and hybrid DoE applications in life sciences. Before joining OXB, Tom spent a number of years working in biomechanics and biomaterials. He also holds multiple degrees in mathematics, statistics and biosciences, bringing a cross-disciplinary approach to advancing scientific research.
Who Should Attend?
This webinar will appeal to those in the following fields or having the following job titles:
- Biotechnology and pharmaceutical professionals
- Cell and Gene Therapy Program Leaders
- Project Managers/Technical Experts
- Research and development
- Cell and gene therapy
- Business development
- Academics
What You Will Learn
Attendees will learn about:
- Advanced digital and physical platform, integrated with automated liquid handlers, which enables automated DoE and multivariate system optimisation
- Evolution of automated analytical workflows for qPCR, ELISA and cell-based assays
- The critical role of plasmid DNA concentration and ratio adjustments in improving titres for lentiviral vectors
- How DoE and multivariate systems optimization accelerate the identification of optimal production parameters, enabling faster, more efficient development of cost-effective and scalable viral vector drug products
Xtalks Partner
Oxford Biomedica
OXB (LSE: OXB) is a quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.
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OXB offers a vast number of unique technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the Tetravecta™ system), dual plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.
OXB, a FTSE4Good constituent, is headquartered in Oxford, UK. It has bioprocessing and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France and near Boston, MA, US. Learn more at www.oxb.com, and follow us on LinkedIn and YouTube.
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