Perspective | Published:

Quality cell therapy manufacturing by design

Nature Biotechnology volume 34, pages 393400 (2016) | Download Citation


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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We thank members of the P.Z. laboratory as well as D. Baksh, M. Curtis, E. Csaszar, J. Lebkowski, A. Lipsitz and R. Preti for constructive comments and apologize to colleagues whose research we were unable to cite due to space constraints. F. Agbanyo, chief of Blood, Cells, Tissues and Organs Division, Health Products and Food Branch Health Canada, Government of Canada is gratefully acknowledged for her careful review and suggested revisions of this manuscript. For clarity, the perspectives expressed in this paper do not necessarily represent the opinion of Health Canada. Y.Y.L. is supported by an NSERC Alexander Graham Bell Canada Graduate Scholarship, and P.W.Z. is supported as the Canada Research Chair in Stem Cell Bioengineering.

Author information


  1. Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.

    • Yonatan Y Lipsitz
    •  & Peter W Zandstra
  2. Centre for Commercialization of Regenerative Medicine, Toronto, Ontario, Canada.

    • Nicholas E Timmins
    •  & Peter W Zandstra
  3. The Donnelly Centre for Cellular and Biomolecular Research, University of Toronto, Toronto, Canada.

    • Peter W Zandstra
  4. Medicine by Design: A Canada First Research Excellence Fund Program, University of Toronto, Toronto, Canada.

    • Peter W Zandstra


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The authors declare no competing financial interests.

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Correspondence to Peter W Zandstra.

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