Recent advances in stem cell research and regenerative medicine are leading towards the realistic commercial prospect of more complex cell-based therapeutic products, offering the potential to revolutionize aspects of healthcare system. To date however, there are no truly ‘large-scale’ cell therapy products available. To achieve successful commercial production, many factors come into play. To name a few; economics, robustness, reproducibility and, what this review is concerned about: scalability. With cell therapies, a change in the processing environment may lead to a product change, which ultimately may be the difference between a successful batch (meeting product specifications) or a failed one . To minimize process changes throughout the scales, processing steps must be carefully selected from an early stage. A particular challenge faced is that current ‘gold standard’ techniques for cell separation are not generally compatible with large scale processes. Dead-end batch centrifugation is a clear example of a process step that is heavily manual, difficult to automate while maintaining sterility, and limited in scalability . The scope of this article is to explore and evaluate current and potential future techniques for cell separation at large scale only.
Masri, F., Hoeve, M. A., De Sousa, P. A., & Willoughby, N. A. (2017). Challenges and advances in scale-up of label-free downstream processing for allogeneic cell therapies. Cell and Gene Therapy Insights, 3(6), 447-467. https://doi.org/10.18609/cgti.2017.041