System for the production of cells and/or cell products
Inventors
Castillo, José • Mairesse, Bastien
Assignees
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Publication Number
US-12036549-B2
Publication Date
2024-07-16
Expiration Date
Abstract
The invention provides a method and a system for the production of viruses or virus derived products. The system comprises a containment enclosure provided with a single entry means and a single exit means which are movable between a closed position and an open position. The containment enclosure comprises at least one production unit comprising at least one bioreactor for culturing the virus, said bioreactor is provided with at least one inlet and at least one outlet; at least one purification unit fluidly connected to the production unit and comprising at least one purification means having at least one inlet and at least one outlet. The system further comprises at least one inactivation and/or at least one gas decontamination unit. The containment enclosure comprises at least one process control device connected to the exit means. The movement of the exit means from the closed position to the open position is controllable by said process control device.
Core Innovation
The invention provides a system for the production of cells, viruses or cells- or virus-derived products that includes a containment enclosure having entry means and exit means movable between a closed position and an open position. The containment enclosure comprises at least one production unit with at least one bioreactor for culturing the cells or virus, the bioreactor being provided with at least one inlet and at least one outlet, and a process control device to collect, monitor or record data on actions performed by the units of the system.
The containment enclosure also comprises at least one gas decontamination unit positioned inside or outside the containment enclosure, configured to perform gas decontamination of the containment enclosure. The process control device is programmed to cause the gas decontamination unit to perform gas decontamination upon completion of the culturing of the cells or virus by the at least one bioreactor, and access to the containment enclosure via the entry means or exit means is provided only after the process control device receives information indicating completion of gas decontamination.
In embodiments, the system includes gas decontamination means and/or an HVAC system providing hot or cool air with a heated air flow at a temperature above 70°C inside the enclosure. Additional units may be incorporated, including a purification device connected to a bioreactor outlet for purification of fluids using one or more selected purification options, and an inactivation unit that performs virus inactivation. The system further supports controlled processing by recording or controlling actions and statuses and may include supporting containment features and decontamination of waste liquid.
Claims Coverage
The document includes one independent claim defining an integrated containment-and-control system, with dependent claims refining gas decontamination implementation, access control, purification, inactivation/disinfection control, and waste liquid decontamination. The inventive features below are extracted from the independent claim and supported refinements.
Movable entry and exit containment enclosure with access gated by gas decontamination completion
A containment enclosure with entry means and exit means movable between a closed position and an open position, wherein access via the entry means or exit means is provided upon receiving information on completion of gas decontamination of the containment enclosure by the gas decontamination unit.
Bioreactor-based culturing production unit with defined inlets and outlets
At least one production unit comprising at least one bioreactor for culturing the cells or virus, where the bioreactor is provided with at least one inlet and at least one outlet.
In-enclosure or external gas decontamination unit configured for gas decontamination
At least one gas decontamination unit positioned inside or outside the containment enclosure and configured to perform gas decontamination of the containment enclosure.
Process control device collecting, monitoring, recording, and triggering decontamination
At least one process control device that collects, monitors or records data on actions performed by the units of the system, and is programmed to cause the gas decontamination unit to perform gas decontamination upon completion of culturing and to provide access only after completion of gas decontamination.
HVAC hot or cool air gas decontamination with heated air flow above 70°C
A gas decontamination unit connected to the containment enclosure that uses an HVAC system to supply hot or cool air so decontamination is achieved by providing a heated air flow at a temperature above 70°C inside the enclosure.
Selected gas decontamination means for the gas decontamination unit
A gas decontamination unit connected to the containment enclosure that incorporates at least one gas decontamination means selected from hydrogen peroxide, aerosol, formaldehyde vaporizing devices, hydrogen peroxide vaporizing devices, aerosol vaporizing devices, or combinations thereof.
Purification device using selected purification modalities from bioreactor outlet
A purification device that receives fluid from the bioreactor outlet and performs purification using one or more selected options from ultrafiltration, diafiltration, centrifugation, washing, and chromatography.
Process control for cell or virus culture with inactivation or disinfection
A process control device that controls cell or virus culture and inactivation or disinfection processes and can connect to at least one unit of a containment enclosure.
Liquid waste decontamination device arranged relative to a liquid waste container
At least one waste decontamination device within the containment enclosure configured to decontaminate liquid waste, with the device positioned upstream or downstream of a liquid waste container.
Overall, the claim set centers on a contained production system integrating a bioreactor-based culturing production unit, a gas decontamination unit, and a process control device that records, monitors, or controls actions and triggers gas decontamination after culturing completion, with access permitted only after gas decontamination completion. Dependent refinements specify HVAC hot or cool air decontamination above 70°C, particular gas decontamination means, selected purification modalities, coordinated control of culture with inactivation or disinfection, and liquid waste decontamination relative to a waste container.
Stated Advantages
Reduced environmental contamination risk.
Ability to run in class C/D cleanrooms.
Smaller equipment for rapid production.
Lower cost.
Automation with reduced personnel intervention.
Documented Applications
Production of cells, viruses, or cells- or virus-derived products in a contained system using a containment enclosure and automated access gating based on gas decontamination completion.
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