Integrity™ Xpansion™ bioreactor systems represent the first commercially-available bioreactors that support safe and cost-efficient large-scale (large volume) production of traditional two-dimensional (2-D) cell cultures, with the advantage of cell culture parameter controls. The 2-D multiplate design of the bioreactors offers the same cell environment as standard multitray technology, but adds the benefit of a closed system for increased protection from potential contamination. In addition, critical cell culture parameters do not change using the systems, successfully mitigating risk during process scale-up for large clinical studies. These features enable easy transfer from existing technologies to the systems, at any stage of a clinical study. Moreover, the bioreactors offer quick scale-up to process design for flexibility and speed in both upstream and downstream processing. By also dramatically reducing the number of operations needed, safety is maximized and cost of goods can successfully be reduced by up to 40 percent. The bioreactors are made of stacked polystyrene plates within a closed system; up to 180 of these plates can be stacked to produce a unit with a surface area of 11m2. The plates are just 1.6mm apart, and the entire bioreactor is about 60cm high and 35cm in diameter, resulting in a completely closed, single-use bioreactor from vessel to sensor. The process is also successfully secured throughout the design, ensuring sterility and reducing the risk of contamination. The cell culture parameters, including pH, DO, and temperature, are read using real-time controls in order to allow process reproducibility and traceability. The systems also monitor and control temperature, dissolved oxygen, pH, and media flow rate. The cell morphology and density could be monitored by digital holography.
ATMI LifeSciences, Bloomington, MN 55438. www.atmi-lifesciences.com or call 952-942-0855