iCELLis™ single-use, fixed-bed bioreactor systems
Productivity and reduced footprint for industrialization of animal cell culture processes in a fixed-bed bioreactor.
iCELLis™ single-use, fixed-bed bioreactor systems
Productivity and reduced footprint for industrialization of animal cell culture processes in a fixed-bed bioreactor.
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Overview
The iCELLis™ bioreactor system is an automated, single-use, fixed-bed bioreactor that provides excellent cell growth conditions for adherent cells. Available in three formats, they deliver scalable performance from 0.5 to 500 m2, supporting process development through clinical and commercial production. Cytiva iCELLis™ bioreactors have many key features, which simplify and intensify processes from vial to final product, enabling products to achieve clinical milestones and reach the market faster.
These features include:
- A compact, high-cell-density fixed-bed, resulting in a significant increase in volumetric productivity compared to traditional stirred tanks
- An optimized media falling film (aka “waterfall”) that provides high levels of oxygenation with low shear
- Predictable scalability from bench-top (0.5 m2) to large-scale manufacturing (500 m2)
- Significant decrease in operational costs and capital investments compared to classical 2D flatware
- Industrial readiness with sensor redundancies, safety interlocks, and IP54+ ratings
- Advanced control automation systems to optimize and regulate the conditions within the bioreactor, ensuring efficient and consistent production; 21 CFR Part 11 compliant software
- A complete regulatory dossier and validation guide for all single-use components
- Fully integrated, single-use sensors for pH, dissolved oxygen (DO), temperature, pressure, and biomass
- A set of tubing assemblies specifically designed to perform key bioreactor operations
- A comprehensive scientific library of application notes, posters, and other case studies
- A global support network of experienced field application scientists and service engineers to help you achieve maximal productivity
- Access to exceptional learning experiences including handbooks, online courses, equipment care training, and service experts to support the discovery of new applications and to optimize protocols and troubleshoot experiments
The iCELLis™ bioreactor systems are available in three formats:
- The iCELLis™ Nano system for process development and small-scale production (0.5 to 4 m2)
- The iCELLis™ 50 system for pilot-scale process development and medium-scale clinical manufacturing (6 to 50 m2)
- The iCELLis™ 500+ system for industrial scale manufacturing (66 to 500 m2)
Detailed product information is available on the product datasheet.
User software and automation
The iCELLis™ bioreactor family is built with our innovative mPath™ Link user interface, which has become an integral part of the Cytiva automation platform. It focuses on supervisory control and data acquisition with recipe management, aiming to provide an automation ecosystem for bioprocess scientists and engineers.
The mPath™ Link software was designed for use in both GMP-regulated and process development environments, meeting all the requirements of an industrial manufacturing environment, including compliance with 21 CFR Part 11 or EudraLex Annex 11. The mPath™ Link software includes tools such as real-time data trending, customizable control loops, on screen operational instructions, recipe management, and reporting. These features make it a powerful tool to help you quickly understand and scale up your process.
For more detailed information on the mPath™ control towers or software, please visit http://www.cytiva.com/mpathlink.
High productivity, reduced footprint
The fixed-bed design of the iCELLis™ bioreactor system makes it well-suited for industrialization of adherent cell processes for both gene therapy and vaccines, providing a large cell growth surface area while keeping the footprint very small. The iCELLis™ bioreactor system accommodates up to 500 m2 of growth area, which, when compared with available surfaces of multitray systems and roller bottles, corresponds to a huge reduction in footprint. The iCELLis™ 500+ 500 m2 system is equivalent to 794 cell stacks with 10 trays and 5882 roller bottles at 850 cm2 each. In addition to footprint reduction, the iCELLis™ bioreactor enables high productivity due to the ability to precisely control process parameters such as pH and dissolved oxygen (DO).
