Delivering patient safety and cost-effective cell production is essential for sustainable and meaningful commercialization of cell therapies. Due to the lack of efficient cell culture technologies, achieving GMP cell therapy standards while avoiding prohibitive expenses is a challenge. Concerning scale, traditional processes and technologies are creating bottlenecks and inefficiencies that lead to risky, complex, high-cost operations, which mean they are quickly becoming unacceptable.
ATMI® LifeSciences has developed a family of Integrity® single-use technologies which are helping to bring flexibility and cost-efficiencies to manufacturing processes. The products around these technologies can be interconnected to a scalable and flexible closed system to help drive safe, GMP-compliant industrialization by simplifying and securing operations, reducing space requirements and facility management. Central to this closed system is the new single-use Integrity Xpansion™ - a compact, multiplate bioreactor system.
The Xpansion system is especially developed for fragile adherent cell culture applications, such as stem cell cultures. The system is industrialized and optimized for safe large-scale production of traditional two dimensional (2-D) cell culture. Its multiplate structure promotes a large cell growth surface area. Its compact, efficient design allows elimination of the usual gas phase between tray stacks and enables an automatically-controlled aeration system which provides advanced gas diffusion.
Automatic controls are available via disposable pH and DO sensors. Temperature monitoring and agitation control are also available. Cell morphology and density can be monitored by digital holography.
- Modular multi-plate design, from 10 to 200 plates (headspace between each plate is 1.6 mm)
- Plates made up of polystyrene
- Treatment for cells adherence
- Cell grow surface availability per plate = 612 cm²
- USP Class VI material
- Disposable probes integrated (pH, DO)
- Real-time monitoring and control of agitation, T°, DO, pH and media flow rate
- Cell morphology and density monitored via specialized holographic microscope
The Xpansion bioreactor system represents the best solution for process industrialization to drive cell therapies to market faster, as it delivers better patient safety and GMP compliance.
Because of its compact structure and large cell growth surface area (up to 122,400cm², equivalent to 20 stacks of 10 multitrays), the Xpansion bioreactor enables production of large amounts of cells in a process easily adapted from traditional T-flask or multitray stacks with the advantage of cell culture parameter controls.
The 2-D multiplate design of the Xpansion bioreactors offer the same cell environment as standard multitray technology but add 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. All of this enables easy transfer from existing technologies to Xpansion systems. 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%.
Integrity Xpansion Bioreactor Highlights and Benefits
- GMP compliant
- Completely single use closed bioreactor from vessel to sensor for sterility and contamination risk reduction
- Multiplate 2-D cell culture design enables easy industrialization of the traditional multitray stacks
- Cell culture reproducibility and traceability by monitoring culture parameters (pH, DO, temperature) and real time controls
- Upstream and downstream processing flexibility and speed: reduction of numbers of operations, complexity and risks related to operations (e.g. seeding, medium exchange, harvest)
- Scalable to follow process development, as needed
- Designed for use in a completely closed system from seeding to harvest
- Integrity® Xpansion™ Multiplate Bioreactor - Data Sheet
- Cell Therapy Process and Cost Model Simulations - White Paper
- Integrity® Xpansion™ Multiplate Bioreactor: Adherent Stem Cell Expansion Poster
- Integrity® Xpansion™ Multiplate Bioreactor - Microscope Poster ISSCR 2012
- Integrity® Xpansion™ Multiplate Bioreactor - Controller Poster ISCT 2012
- Transfer of Hepatic Progenitor Stem Cell Culture Process from Multitray Stacks to the Integrity® Xpansion™ Multiplate Bioreactor
- Using Small Scale Bioreactor Mimics to Scale up Human Embryonic Stem Cell Culture