Stem Cell Bioprocessing Fundamentals and Principles.pdf - J R Soc Interface(2009 6 209232 doi:10.1098\/rsif.2008.0442 Published online 25 November 2008

Stem Cell Bioprocessing Fundamentals and Principles.pdf - J...

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R EVIEW Stem cell bioprocessing: fundamentals and principles Mark R. Placzek, I-Ming Chung, Hugo M. Macedo, Siti Ismail, Teresa Mortera Blanco, Mayasari Lim, Jae Min Cha, Iliana Fauzi, Yunyi Kang, David C. L. Yeo, Chi Yip Joan Ma, Julia M. Polak, Nicki Panoskaltsis and Athanasios Mantalaris* Biological Systems Engineering Laboratory, Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London, South Kensington Campus, London SW7 2AZ, UK In recent years, the potential of stem cell research for tissue engineering-based therapies and regenerative medicine clinical applications has become well established. In 2006, Chung pioneered the first entire organ transplant using adult stem cells and a scaffold for clinical evaluation. With this a new milestone was achieved, with seven patients with myelomeningo- cele receiving stem cell-derived bladder transplants resulting in substantial improvements in their quality of life. While a bladder is a relatively simple organ, the breakthrough highlights the incredible benefits that can be gained from the cross-disciplinary nature of tissue engineering and regenerative medicine (TERM) that encompasses stem cell research and stem cell bioprocessing. Unquestionably, the development of bioprocess technologies for the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic as therapeutics necessitates the application of engineering principles and practices to achieve control, reproducibility, automation, validation and safety of the process and the product. The successful translation will require contributions from fundamental research (from develop- mental biology to the ‘omics’ technologies and advances in immunology) and from existing industrial practice (biologics), especially on automation, quality assurance and regulation. The timely development, integration and execution of various components will be critical—failures of the past (such as in the commercialization of skin equivalents) on marketing, pricing, production and advertising should not be repeated. This review aims to address the principles required for successful stem cell bioprocessing so that they can be applied deftly to clinical applications. Keywords: stem cell; bioprocessing; tissue engineering 1. INTRODUCTION The success of stem cell bioprocessing relies on robust and reproducible culture conditions and processes. For stem cell bioprocessing, this includes the scale-up of stem cells to a differentiated end product of sufficient quality and quantity for clinical and commercial goals. The considerable cost with respect to consumables, labour and time as well as the inherent variability in manual processes not only make this an unattractive option but also render it commercially unviable.
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