Challenges and advances in scale-up of label-free downstream processing for allogeneic cell therapies

Fernanda Masri, Marieke A. Hoeve, Paul A. De Sousa, Nicholas A. Willoughby

Research output: Contribution to journalReview article

Abstract

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 [1]. 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 [1]. The scope of this article is to explore and evaluate current and potential future techniques for cell separation at large scale only.
Original languageEnglish
Pages (from-to)447-467
Number of pages21
JournalCell and Gene Therapy Insights
Volume3
Issue number6
DOIs
Publication statusPublished - 4 Aug 2017

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Scalability
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Centrifugation
Processing
Stem cells
Specifications
Economics
Regenerative Medicine

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title = "Challenges and advances in scale-up of label-free downstream processing for allogeneic cell therapies",
abstract = "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 [1]. 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 [1]. The scope of this article is to explore and evaluate current and potential future techniques for cell separation at large scale only.",
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Challenges and advances in scale-up of label-free downstream processing for allogeneic cell therapies. / Masri, Fernanda; Hoeve, Marieke A.; De Sousa, Paul A.; Willoughby, Nicholas A.

In: Cell and Gene Therapy Insights, Vol. 3, No. 6, 04.08.2017, p. 447-467.

Research output: Contribution to journalReview article

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AB - 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 [1]. 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 [1]. The scope of this article is to explore and evaluate current and potential future techniques for cell separation at large scale only.

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