title: Comparability of automated human induced pluripotent stem cell culture: a pilot study.
abstract: Consistent and robust manufacturing is essential for the translation of cell therapies, and the utilisation automation throughout the manufacturing process may allow for improvements in quality control, scalability, reproducibility and economics of the process. The aim of this study was to measure and establish the comparability between alternative process steps for the culture of hiPSCs. Consequently, the effects of manual centrifugation and automated non-centrifugation process steps, performed using TAP Biosystems' CompacT SelecT automated cell culture platform, upon the culture of a human induced pluripotent stem cell (hiPSC) line (VAX001024c07) were compared. This study, has demonstrated that comparable morphologies and cell diameters were observed in hiPSCs cultured using either manual or automated process steps. However, non-centrifugation hiPSC populations exhibited greater cell yields, greater aggregate rates, increased pluripotency marker expression, and decreased differentiation marker expression compared to centrifugation hiPSCs. A trend for decreased variability in cell yield was also observed after the utilisation of the automated process step. This study also highlights the detrimental effect of the cryopreservation and thawing processes upon the growth and characteristics of hiPSC cultures, and demonstrates that automated hiPSC manufacturing protocols can be successfully transferred between independent laboratories.
authors: Centre for Biological Engineering, Loughborough University, Loughborough, LE11 3TU, UK.|Cell and Gene Therapy Platform CMC, GlaxoSmithKline PLC, Stevenage, UK.
authors: Peter R T
authors: PR
authors: Archibald
authors: Centre for Biological Engineering, Loughborough University, Loughborough, LE11 3TU, UK. a.chandra@lboro.ac.uk.
authors: Amit
authors: A
authors: Chandra
authors: TAP Biosystems, Part of the Sartorius Stedim Biotech Group, Royston, UK.
authors: Dave
authors: D
authors: Thomas
authors: CECS/I-Stem, AFM Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, 2 rue Henri Desbruères, 91100, Corbeil-Essonnes, France.
authors: Olivier
authors: O
authors: Chose
authors: CECS/I-Stem, AFM Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, 2 rue Henri Desbruères, 91100, Corbeil-Essonnes, France.
authors: Emmanuelle
authors: E
authors: Massouridès
authors: CECS/I-Stem, AFM Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, 2 rue Henri Desbruères, 91100, Corbeil-Essonnes, France.
authors: Yacine
authors: Y
authors: Laâbi
authors: Centre for Biological Engineering, Loughborough University, Loughborough, LE11 3TU, UK.
authors: David J
authors: DJ
authors: Williams
mesh_terms: D000943:Antigens, Differentiation / Q000096:biosynthesis; D001331:Automation / Q000295:instrumentation* / Q000379:methods*; D018929:Cell Culture Techniques / Q000295:instrumentation* / Q000379:methods*; D002460:Cell Line; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000166:cytology* / Q000378:metabolism; D010865:Pilot Projects
chemical_list: D000943:Antigens, Differentiation
keywords: Automation; Centrifugation; Characterisation; Comparability; Pluripotent stem cell; Scalable