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iCELLis™, the world’s first fully integrated high-cell density bioreactor is designed to simplify your process, by combining the advantages of single-use technologies with the benefits of a fixed-bed
詳細介紹
iCELLis™，世界上*個*集成的、設(shè)計緊湊、執(zhí)行快速、簡潔易用、高細胞密度一次性使用的生物反應(yīng)器!
Overview
iCELLis™, the world’s first fully integrated high-cell density bioreactor is designed to simplify your process, by combining the advantages of single-use technologies with the benefits of a fixed-bed system. Thanks to its compact design - for a quick implementation and more ease of use – iCELLis represents the new generation single-use bioreactors.
Central to the iCELLis bioreactor technology is the use of a compact fixed-bed, filled with custom macrocarriers. This matrix is made of medical grade polyester microfibers and provides in only 25L volume, up to 500m² growth area available to the cells. This surface is equivalent to the surface of 3000 Roller Bottles （1700cm² each）. iCELLis bioreactors are supplied pre-packed with macrocarriers. Compared to standard stirred tank bioreactor using microcarriers, the iCELLis technology leads to a dramatic simplification of cell culture process. It enables to avoid delicate and time consuming manual operations: sterilization and hydration of microcarriers, and bead-to-bead transfers from preculture to final process.
With the biomass multiplication occurring in the fixed-bed, iCELLis bioreactors can be inoculated at very low density. The number and volume of pre-culture steps are reduced considerably: 20 Roller Bottles （1700 cm²） are can be sufficient to inoculate an iCELLis 500 bioreactor （500 m² of available surface to the cells）. As a consequence of this process simplification, manual operations and associated costs are reduced dramatically.
Evenly-distributed media circulation is achieved by a built-in magnetic drive impeller, ensuring low shear stress and high cell viability. The cell culture medium flows through the fixed-bed from the bottom to the top. At the top, the medium falls as a thin film down the outer wall where it takes up O2 to maintain high KL.a. in the bioreactor. This unique waterfall oxygenation, together with a gentle agitation and biomass immobilization, enables compact iCELLis to achieve and maintain high-cell densities, equaling the productivity of much larger stirred tank units.
Process simplification, from vial thawing to final product, is at the heart of the iCELLis platform. As cells are immobilized in the fixed-bed and iCELLis operates in perfusion mode, there is no need for centrifugation to harvest the cells, which simplifies further the downstream process. Last but not least, in order to reduce process development time, the perfusion device is integrated into the iCELLis™ skid.
Highlights & Benefits
Process simplification, from pre culture steps to final product:
Inoculation at very low cell density, simplifying seed trains operations as no intermediate bioreactor is required
Fixed-bed design avoids numerous operations involved by the use of µbeads, 
Straightforward implementation:
Standard process designed for quick implementation （less than one year）,
iCELLis Brochure
- Viral Entities Production at Manufacturing Scale Using the Integrity™ iCELLis™ Disposable Fixed-Bed Reactor
Linear scalability, from R&D scale to manufacturing scale,
Compact high-cell-density fixed-bed bioreactor:
Up to 500m² growth area in only 25L volume – equivalent to 3000 Roller Bottles （1700cm² each）
Dramatic decrease of operations costs and investments.
Single-use bioreactor made up USP Class VI rigid plastic to ensure process reliability
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二、Nucleo™ single-use bioreactor
The Nucleo™ single-use bioreactor was developed to provide a complete turn-key solution to cell culturists as a next generation alternative to stainless steel classical bioreactors and existing single-use bioreactors, without need for extended validations. The Nucleo bioreactor platform is the result of the combined expertise of Pierre Guerin – Biolafitte （bioreactors and control systems）, ATMI LifeSciences （ultra-pure bioprocess films and disposable mixing technology） and Aris （cell culture and cell culture process optimizations）.
Nucleo, the next generation of single-use bioreactors, represents the 2009, 2012 ATMI of the art response to the evolution of biotech processes. It is perfectly suited to laboratory environments, process development centers, clinical material supply and flexible GMP manufacturing. The Nucleo bioreactor vessel, which offers comparable functionality to classical stirred tank bioreactors, is a single use bag （ATMI） integrating an internal paddle mixing and sparger system （ATMI）. The bag, paddle and fittings are single-use and all contact surfaces are discarded after use. The paddle is enclosed in a medical grade ULDPE sleeve, with the same contact material as the bag itself, and is coupled on top of the vessel with the mechanical mixing head.
Highlights & Benefits
- Superior mixing capabilities with drastically reduced shear stress
- Innovative sparging device for superior oxygenation and kLa
- Adapted for c*tion of suspended or adherent cells at very high densities
- Compatible with batch, fed-batch and perfusion processes
- Scalable customizable system
- Ergonomic: modular or fully integrated configuration
- Control of all process parameters ensuring optimal c*tion conditions
- No need for CIP/SIP （disposable bag technology）
- Avoid all cross contamination risks
- User-friendly control interface fully compliant to GAMP V5 and 21 CFR PART 11
- Very low working volume
- All product contact surface of same material （ATMI medical grade ULDPE）
- Nucleo Brochure
- Nucleo Options List
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Integrity™ PadReactor™
The Integrity™ PadReactor™ system is a single-use bioreactor specifically designed to fulfill the needs of cell culturists. It is perfectly suited to laboratory environments, process development centers, clinical material supply and flexible GMP manufacturing. The PadReactor offers an open architecture controller platform, which gives the end user the opportunity to choose a preferred controller or use an existing control system. The bioreactor vessel, which offers comparable functionality to classical stirred tank bioreactors, is a single-use bag integrating an internal paddle mixing and sparger system. This innovative bag design allows a non-invasive connection to the system. The paddle is enclosed in a medical grade ULDPE sleeve, made from the same contact material as the bag itself, and is coupled on top of the vessel with the mechanical mixing head. The Integrity PadReactor utilizes disposable mixing bags made from Integrity TK8 bioprocess film. The product-contacting layer of TK8 film is blow-extruded in-house by ATMI under cleanroom conditions using medical-grade ultra low-density polyethylene resin. It is then laminated to create a gas barrier film of exceptional cleanliness, strength, and clarity that is animal derived component free （ADCF） and complies fully with USP Class VI requirements. The Integrity PadReactor single-use bioreactor consists of the following: Drive Unit: The flexible drive unit allows the system to c*te cells in disposable bags. One drive unit can allow the user to mix in multiple disposable mixing bags of various sizes. Each system comes with the appropriate mixing stick for your container. Retaining Tank: The purpose of the retaining tank is to support the mixing bag and provide mobility before and after operation. Various tank sizes and options are available. Bioreactor Vessel: The reactor vessel uses an innovative bag design that allows a non-invasive connection to the mixer. Mixing is achieved when the integrated paddle/sparger inside the bag rotates within the bag.
Highlights & Benefits