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Nat Biotechnol. 2016 Apr;34(4):393-400. doi: 10.1038/nbt.3525.

Quality cell therapy manufacturing by design.

Author information

Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.
Centre for Commercialization of Regenerative Medicine, Toronto, Ontario, Canada.
The Donnelly Centre for Cellular and Biomolecular Research, University of Toronto, Toronto, Canada.
Medicine by Design: A Canada First Research Excellence Fund Program, University of Toronto, Toronto, Canada.


Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

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