Bioreactor User Guide
This user guide provides an overview of PBS Biotech's Vertical-Wheel® Bioreactor platform for cell therapy process development and manufacturing. It describes the system's low-shear hydrodynamics, homogeneous mixing, and scalable vessel design for expanding iPSCs, MSCs, CAR-T, NK, and other mammalian cell types. The guide covers temperature control, gas management, agitation, oxygen transfer, cell density performance, utility requirements, and extractables testing. It also includes troubleshooting information, product configurations for PBS-MINI, PBS-3, PBS-15, and PBS-80 systems, a hiPSC sampling and counting protocol, and guidance on cGMP, ISO 9001:2015, and FDA 21 CFR Part 11 compliance.
This protocol provides detailed instructions for expanding mesenchymal stem cells on microcarriers using PBS-Mini bioreactors with Vertical-Wheel technology. The document covers the complete workflow from recovery of cryopreserved MSCs and expansion in adherent culture through inoculation, suspension culture, sampling, medium exchange, and harvest in three-dimensional bioreactor systems the PBS-Mini bioreactor. Recommended process parameters are based on internal optimization studies using multiple MSC lines and media formulations. Guidance is provided for microcarrier preparation, cell…
This protocol provides step-by-step guidance for forming and expanding pluripotent stem cell aggregates in PBS-MINI Vertical-Wheel® bioreactors. The workflow begins with thawing and adherent seed-train culture in T-flasks, followed by transfer to three-dimensional suspension culture in 0.1 L or 0.5 L vessels. Instructions cover inoculation, medium exchange, sampling, morphology assessment, metabolite and pH analysis, cell counting, viability testing, and harvest in the PBS-Mini bioreactor. The document presents recommended starting parameters for seeding density, working volume, agitation…
This publication reports a fully suspended process for expansion and six-stage differentiation of human induced pluripotent stem cells into stem cell-derived islets in 0.1 L and 0.5 L Vertical-Wheel® Bioreactors. A fivefold increase in vessel volume produced a twelvefold increase in islet-equivalent yield without compromising islet structure. The 27-day process generated endocrine populations expressing ?-, ?-, and ?-cell markers with glucose-responsive insulin secretion and transcriptomic characteristics approaching adult islets. The study also evaluated donor-derived iPSC lines, cellular…
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