ATMI Inc: New Single-Use Bioreactor Systems for Improved Performance and Efficiencies in Manufacturing Cell-Based Products

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ATMI, Inc. today launched a new technology for enabling large-scale, cell-based manufacturing as the company unveiled its Integrity Xpansion Bioreactor Systems at the Cell Therapy Manufacturing Conference in Brussels, Belgium. The new line of bioreactors are part of the ATMI LifeSciences Integrity family of single-use technologies and have been especially developed for fragile adherent cell culture applications (such as stem cells) on a large scale. The Integrity Xpansion product line represents 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.

"It is essential that cell therapies can be made efficiently and effectively on a large scale for them to reach the market. Yet, it can be a challenge to achieve GMP standards during large-scale production because of a lack of efficient cell culture technologies -- many of which can lead to bottlenecks and prohibitive costs," says Jose Castillo, the global director of cell culture technologies for ATMI LifeSciences. "The Xpansion bioreactors represent a solution for process industrialization for cell therapies. Both patient safety and GMP compliance have been factored into the system's design, as has operational simplicity. Space and cost requirements have been drastically reduced, enabling the user to operate in a manner that existing large-scale technologies cannot match."

The 2-D multiplate design of the Xpansion 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 Xpansion systems, successfully mitigating risk during process scale-up for large clinical studies. It is these features that enable easy transfer from existing technologies to Xpansion systems at any stage of a clinical study. Moreover, Xpansion 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%.

Xpansion bioreactors are made up 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. As the plates are close together, just 1.6mm apart, the entire bioreactor is about 60cm high and is 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. Xpansion bioreactor systems also monitor and control temperature, dissolved oxygen, pH, and media flow rate. The cell morphology and density could be monitored by digital holography.

Xpansion bioreactors integrate with the full line of ATMI technologies, including the Integrity brand of single-use technologies ranging from mixers to bioprocess vessels and bags. The Integrity platform provides dedicated technologies to support each step of cell therapy manufacturing from cell culture to cell concentration into a closed system.

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