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Table 1 Summary of key parameters in human T cell biomanufacturing

From: Novel biomanufacturing platform for large-scale and high-quality human T cells production

Biomanufacturing Parametersa,b,c Scale (mL) VCDmaxd (106 cells/mL) TVC (106 cells) Viabilityd (%) μd(hr− 1) Tdc(hr)
Medium AIM-V 30 1.90 ± 0.11 56.9 ± 3.2 76.8 ± 2.5e 0.030 ± 0.001 23.2 ± 0.8
OpTmizer 30 2.83 ± 0.12 84.8 ± 3.6 87.5 ± 1.4e 0.030 ± 0.004 23.1 ± 2.9
ImmunoCult 30 3.49 ± 0.52 104.6 ± 15.5 91.8 ± 1.1 0.041 ± 0.000 17.1 ± 0.2
Seed and stimulation 1st stimulated Day 0 seed 80 8.33 ± 0.11 666.0 ± 8.5 93.0 ± 1.4 0.053 ± 0.001 13.0 ± 0.2
1st stimulated Day 2 seed 80 1.89 ± 0.04 151.2 ± 3.4 95.0 ± 1.4 0.029 ± 0.002 23.8 ± 1.5
1st stimulated Day 5 seed 80 0.55 ± 0.02 44.1 ± 2.0 96.0 ± 1.4 0.007 ± 0.001 99.5 ± 17.2
2nd stimulated Day 0 seed 80 3.98 ± 0.06 318.4 ± 4.5 93.0 ± 0.0 0.042 ± 0.002 16.7 ± 0.7
Scale-upf T75 10 4.05 ± 0.13 40.5 ± 1.3 90.5 ± 0.7 0.034 ± 0.002 20.4 ± 0.9
SF125 30 3.65 ± 0.18 109.4 ± 5.3 91.5 ± 2.1 0.041 ± 0.001 16.9 ± 0.4
Spinner 80 3.98 ± 0.06 318.4 ± 4.5 93.0 ± 0.0 0.042 ± 0.002 16.7 ± 0.7
Bioreactor 800 6.40 ± 0.46 5120.0 ± 367.7 94.0 ± 1.4 0.046 ± 0.002 15.2 ± 0.7
  1. Notes
  2. aThe human T cell biomanufacturing was performed in spinner flasks for 4 days with basal medium of OpTmizer, feed of 30 U/mL IL-2 and 1st stimulation on Day 0 and Day 2, unless otherwise specified.
  3. bSamples from multiple donors were used in the biomanufacturing process development, and T cells isolated from the same donor were used in the evaluation of one biomanufacturing parameter (i.e., medium, seed and stimulation, and scale-up). Significant difference between bioreactor runs in triplicate with p ≤ 0.05 was considered in the two-tailed t test. The results of cross donor comparison are presented in Fig. 3.
  4. cAll data are presented as mean ± standard error of the mean (SEM).
  5. dThe variation in cell growth parameters, such as VCD, viability and cell growth rate, was caused by the different biomanufacturing process parameters.
  6. eThe viabilities of the T cells when reaching maximal VCD are presented. The relatively low harvest viability in the medium evaluation study was caused by an extended seed culture process in the early stage of process development, i.e. 6 days instead of 4 days.
  7. fThe scale-up strategy was designed following the procedure described in Fig. 1.