Abstract
Automation of cell culture processes is necessary to achieve scalable and reproducible manufacture of cell-based therapies. CTX0E03 is a near-clinic neural stem cell line for stroke therapy. The transfer of the CTX0E03 manufacture process from a manual to a completely automated process is demonstrated by (a) adapting the manual process to conform to the automated platform and (b) conducted a large scale (20 × T175 flasks) automated CTX0E03 expansion in accordance with the working bank to drug substance lot manufacture schedule. The automated lot was within the GMP release specification for viability, growth rate, nestin immunoreactivity and transcriptome equivalence.
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Thomas, R.J., Hope, A.D., Hourd, P. et al. Automated, serum-free production of CTX0E03: a therapeutic clinical grade human neural stem cell line. Biotechnol Lett 31, 1167–1172 (2009). https://doi.org/10.1007/s10529-009-9989-1
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DOI: https://doi.org/10.1007/s10529-009-9989-1