Biomanufacturing suite and methods for large-scale production of cells, viruses, and biomolecules
Inventors
HIRSCHEL, Mark • Wojciechowski, Robert J. • Arneson, Kim
Assignees
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Publication Number
US-10662401-B2
Publication Date
2020-05-26
Expiration Date
Abstract
The present invention provides a production module for large-scale production of cells and/or cell-derived products such as antibodies or virus; a production suite comprising a plurality of functionally connected production modules of the invention; and a method for large-scale production of cells and/or cell-derived products using the production modules and/or production suites of the invention.
Core Innovation
The invention relates to a biomanufacturing system for large-scale, automated, sterile production of cells and cell-derived products, including antibodies, proteins, viruses, virus-like particles, and viral vectors. It addresses producing cells and cell-derived products in a production module that supports cell culture growth while enabling an arrangement suitable for a production suite, including operation that generates batch records and can be monitored and controlled.
A core element is a reusable instrument module adapted for removable attachment to a disposable cultureware module. The cultureware module includes a plurality of hollow-fiber bioreactors mounted to an interface plate, with an intracapillary reservoir and an extracapillary reservoir, and each hollow-fiber bioreactor has an intracapillary space and an extracapillary space connected by a flow path.
The instrument module includes hardware to support cell culture growth, including a pump for circulating cell culture medium through the plurality of hollow-fiber bioreactors. The instrument module further includes an intracapillary manifold connected to the intracapillary space and the intracapillary reservoir and an extracapillary manifold connected to the extracapillary space and the extracapillary reservoir. The production suite includes an environment-controlled room with filtration and containment, controlled ingress/egress, hot-swappable modules, and external monitoring, including video monitoring.
Claims Coverage
The independent claim describes a production module combining a disposable cultureware module with multiple hollow-fiber bioreactors and an instrument module that circulates culture medium using intracapillary and extracapillary manifolds, with removable attachment between modules. Three inventive features are identified across the claims.
Hollow-fiber bioreactor cultureware with intracapillary and extracapillary reservoirs connected by flow paths
A cultureware module comprising a plurality of hollow-fiber bioreactors with an intracapillary space and an extracapillary space, an intracapillary reservoir, an extracapillary reservoir, and each hollow-fiber bioreactor connected to an adjacent hollow-fiber bioreactor by a flow path.
Instrument module with medium circulation via intracapillary and extracapillary manifolds
An instrument module comprising hardware to support cell culture growth, including a pump for circulating cell culture medium through the plurality of hollow-fiber bioreactors, an intracapillary manifold connected to the intracapillary space and the intracapillary reservoir, and an extracapillary manifold connected to the extracapillary space and the extracapillary reservoir.
Removable attachment between instrument module and cultureware module
The instrument module and the cultureware module are adapted for removable attachment to one another.
Overall, the claim coverage focuses on a detachable production module architecture in which a cultureware module with multiple hollow-fiber bioreactors and intracapillary/extracapillary reservoirs is paired with an instrument module that circulates medium through intracapillary and extracapillary manifolds, enabling cell culture growth in a production suite environment.
Stated Advantages
Large-scale, automated, sterile production of cells and cell-derived products.
Production suitable for a production suite environment with external monitoring, including video monitoring.
Hot-swappable modules enabling removable attachment between instrument module and cultureware module.
Documented Applications
Production of monoclonal antibodies, viruses, virus-like particles, influenza, and viral vectors.
Expansion of patient cells.
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