Quality cell therapy manufacturing by design

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


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biopharmaceutics* / methods
  • Biopharmaceutics* / standards
  • Cell- and Tissue-Based Therapy* / methods
  • Cell- and Tissue-Based Therapy* / standards
  • Humans
  • Quality Control
  • Research Design*
  • Risk Assessment
  • Technology, Pharmaceutical* / methods
  • Technology, Pharmaceutical* / standards