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Engineering Characterization of Small-Scale Bioreactors for Large-Scale hiPSC Production.

Pedro Vicente1,2, Ana Meliciano1,2, Cláudia Diniz1,2

  • 1iBET, Instituto de Biologia Experimental e Tecnológica, Oeiras, Portugal.

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Summary
This summary is machine-generated.

Scalable stirred-tank bioreactors (STB) enable human induced pluripotent stem cell (hiPSC) expansion for cell therapies. This study demonstrates successful scale-up using constant power input, maintaining hiPSC quality and viability.

Keywords:
hiPSC expansionmixingpower numberscale‐upstirred tank bioreactorsuspension dynamics

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Area of Science:

  • Biotechnology
  • Cell Therapy
  • Bioprocess Engineering

Background:

  • Human induced pluripotent stem cells (hiPSC) show promise for cell therapies.
  • Scalable stirred-tank bioreactors (STB) are crucial for meeting global demand.
  • Shear stress in bioreactors requires careful management to ensure cell health.

Purpose of the Study:

  • To characterize mixing and suspension dynamics in small-scale DASGIP bioreactors.
  • To establish a scale-up strategy for hiPSC expansion in single-use STBs.
  • To evaluate the impact of scale-up on hiPSC expansion, viability, and quality.

Main Methods:

  • Engineering characterization to determine impeller power number.
  • Investigation of mixing and suspension dynamics in 0.2 L DASGIP-STB.
  • Process transfer and scale-up from 0.2 L to 2 L single-use STBs using constant power input per volume (P/V).

Main Results:

  • Impeller power number estimated at 0.5 for DASGIP-STB.
  • Successful hiPSC expansion process transfer and scale-up to 0.2 L and 2 L single-use STBs.
  • Maintained hiPSC expansion, viability, metabolism, and quality attributes (pluripotency, differentiation potential) during scale-up.

Conclusions:

  • Constant power input per volume is an effective scale-up criterion for hiPSC expansion in STBs.
  • Single-use stirred-tank bioreactors can be reliably scaled for hiPSC production.
  • This scalable bioprocess supports the development of hiPSC-based cell therapies.