Moving towards decentralized manufacturing of cell and gene therapy products through automationPublished: November 11, 2019
Current manufacturing practices for most cell therapy processes follow a centralized manufacturing model to control consistency and quality of the final drug product. However, challenges arise when the demand for cell therapy product increases and production is strained due to overly manual production methods. This can make a centralized manufacturing model an unfavourable option for large scale production of cell and gene therapy products. Early implementation of automation can support your production of CAR T cells following a decentralized manufacturing model. Watch this On Demand webinar to learn more about implementing automation for your decentralized manufacturing process with high quality final products.
- Why implement a decentralized manufacturing process?
- How to obtain drug product consistency when decentralizing your manufacturing process
- How to overcome the challenges associated with upscaling cell therapy production through automating your process
- What technology is currently available for automating CAR T cell production processes?
Dr Ian Johnston, Senior Project Manager, R&D, Miltenyi Biotec
Dr. Johnston is responsible for the development of cutting edge technologies to enable cell and gene therapies to be applied routinely in the clinic. Since joining Miltenyi Biotec in 1999, Dr. Johnston has developeda number of reagents and procedures to improve the efficiency of genetic modification of primary cells such as human T and stem cells. A number ofthese procedures have been fully automated on a functionally closed cell processing platform – the CliniMACS® Prodigy. In addition, Dr. Johnston has lead development of numerous products for magnetic isolation of cells, molecules, organelles and for use in the field of HIV research. He has been Principle Investigator on a number of European consortium grants focused on the genetic modification of stem cells, most recently Cell-PID and SCIDNET. His group is also investigating new targets for Chimeric Antigen Receptors (CAR) to be used in T cell cancer immunotherapies.
Prior to joining Miltenyi, he studied Natural Sciences at Cambridge University where he also completed a PhD studying immunopathological mechanisms in the CNS. This was followed by postdoctoral research at Würzburg University with Prof. Volker ter Meulen working with recombinantmeasles virus systems, supported by two fellowships from the Wellcome Trust and Alexander von Humboldt Foundation.
Nick Medcalf, FREng FIChemE CChem CEng Head of Advanced Therapies and Enabling Programmes, Ageing Society, Health and Nutrition Directorate, UK Research and Innovation
Nick Medcalf is currently Deputy Challenge Director for the Industrial Strategy Challenge Fund (Medicines Manufacturing) at UK Research and Innovation with responsibility for the delivery of a portfolio of capital and R&D funding competitions as well as generating new proposals for grant investment.
Prior to this appointment Nick was Professor of Regenerative Medicine Manufacture at Loughborough University from 2013 to 2017 under an EPSRC Manufacturing Fellowship Scheme following 36 years in the healthcare industry. He has a particular interest in improving the options for manufacture and supply of advanced therapeutics by making available appropriate technology for novel and effective models of business and operation. He is an active member of the Enterprise Hub at the Royal Academy of Engineering.
Dr Álvaro Urbano-Ispizua, Director of the Institute of Hematology and Oncology, Hospital Clínic de Barcelona
Dr Álvaro Urbano-Ispizua is currently Director of the Institute of Hematology and Oncology of Hospital Clinic of Barcelona and Full Professor of Medicine at the University of Barcelona. He is author or co-author of more than 250 articles. Journals in which he has published original articles include Lancet, Blood, Journal of Clinical Oncology, British Journal of Haematology, Cancer Research, Experimental Haematology, Leukaemia, Haematologica, and Bone Marrow Transplantation. Dr Urbano-Ispizua serves on the editorial board of Bone Marrow Transplantation, Haematologica, and Experimental Hematology.
Dr Marc-Olivier Baradez, Lead Scientist Analytical Development, Cell and Gene Therapy Catapult
Marc-Olivier Baradez is Lead Scientist in the Industrialisation team at the Cell and Gene Therapy Catapult. He has over 13 years of industrial experience in the implementation of analytical strategies for the characterisation of cell therapies. He is currently the Catapult’s Strategic Lead for its core Data programme, focusing on high-throughput data generation, data handling and analysis, innovative methodologies for Quality-by-Design and in-process controls in the context of Intelligent Manufacturing, across a wide portfolio of cell and gene therapy products and processes. Marc-Olivier’s multidisciplinary expertise lies in experimental strategies supporting high-throughput multivariate quantitative approaches, in which established and new technologies are integrated to characterise cell products and their manufacturing processes. He was previously Science Leader in Cell Metrology at LGC, the UK designated National Measurement Institute for chemical and bio-measurements. He started his industrial career as Senior Scientist at ReNeuron, where he characterised the company’s first clinical neural stem cell line for stroke therapy.