title: Achieving Efficient Manufacturing and Quality Assurance through Synthetic Cell Therapy Design.
abstract: New methods to manipulate gene and cell state can be used to engineer cell functionality, simplify quality assessment, and enhance manufacturability. These strategies could help overcome unresolved cell therapy manufacturing challenges and complement frameworks to design quality into these complex cellular systems, ultimately increasing patient access to living therapeutics.
authors.affiliation: Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON M5S 3G9, Canada.
authors.forename: Yonatan Y
authors.initials: YY
authors.lastname: Lipsitz
authors.affiliation: Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, ON K1A 0K9, Canada; CCRM, Toronto, ON M5G 1L5, Canada.
authors.forename: Patrick
authors.initials: P
authors.lastname: Bedford
authors.affiliation: Dark Horse Consulting, Campbell, CA 95008, USA.
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Davies
authors.affiliation: CCRM, Toronto, ON M5G 1L5, Canada.
authors.forename: Nicholas E
authors.initials: NE
authors.lastname: Timmins
authors.affiliation: Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON M5S 3G9, Canada; CCRM, Toronto, ON M5G 1L5, Canada; The Donnelly Centre for Cellular and Biomolecular Research, University of Toronto, Toronto, ON M5S 3E1, Canada; Medicine by Design: A Canada First Research Excellence Fund Program, University of Toronto, Toronto, ON M5S 3E1, Canada. Electronic address: peter.zandstra@utoronto.ca.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Zandstra
mesh_terms: D058045:Artificial Cells / Q000166:cytology*; D060846:Cell Engineering; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D006801:Humans; D012926:Social Control, Formal; D057170:Translational Research, Biomedical