System, apparatus and method for biomolecules production
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10494421-B2
Publication Date
2019-12-03
Expiration Date
Abstract
An automated method for the production of cells and/or biomolecules such as protein or peptides includes culturing cells in at least one high cell density bioreactor, thereby fluidly connecting said bioreactor with a culture medium supply and a gas or gaseous mixture; fluidly connecting said bioreactor with a downstream unit; and growing cells to a density at least 50 million cells per ml. The total volume of the bioreactor is at least 10 liters. A system suitable for implementation of the automated method above is a small-scale and cupboard-sized system, which can be placed in a portable clean room.
Core Innovation
The invention relates to an integrated, automated system of producing antibodies and vaccines. The system includes a cell culturing unit and a downstream unit fluidly connected to each other, wherein the cell culturing unit comprises at least one perfusion bioreactor configured to allow growing cells at a density of at least 50 million cells per ml. A total volume of the perfusion bioreactor is in a range of 10 to 900 liters.
A supplier is configured to supply the perfusion bioreactor with a cell medium and a gas or gaseous mixture. The system uses a single supply line that provides the cell medium and the gas or gaseous mixture to the perfusion bioreactor. The system is implemented in a portable chamber, suitable for a portable clean room.
The system architecture for producing antibodies and vaccines is devoid of a recirculation loop. The system is positioned to reduce contamination risk, while enabling downstream processing of a predefined small-volume supernatant in continuous or parallel fashion.
Claims Coverage
The provided material includes two independent claims. Both independent claims center on a perfusion bioreactor-based cell culturing unit with high cell density, a fluid connection to a downstream unit, delivery of both cell medium and a gas or gaseous mixture via a single supply line, and constraints on system implementation/architecture.
Integrated bioreactor-to-downstream antibody and vaccine system in a portable clean room
A system of producing antibodies and vaccines comprising a cell culturing unit and a downstream unit fluidly connected to each other, where the cell culturing unit comprises at least one perfusion bioreactor configured to grow cells at a density of at least 50 million cells per ml; a total volume of the perfusion bioreactor is in a range of 10 to 900 liters; and the system is implemented in a portable chamber suitable for a portable clean room.
Single supply line providing cell medium and gas or gaseous mixture to the perfusion bioreactor
A supplier is configured to supply the perfusion bioreactor with a cell medium and a gas or gaseous mixture, wherein a single supply line provides the cell medium and the gas or gaseous mixture to the perfusion bioreactor.
Perfusion bioreactor architecture using a system devoid of a recirculation loop
A system of producing antibodies and vaccines comprising a cell culturing unit and a downstream unit fluidly connected to each other, where the cell culturing unit comprises at least one perfusion bioreactor configured to allow growing cells at a density of at least 50 million cells per ml with a total volume of 10 to 900 liters, and wherein the system is devoid of a recirculation loop.
Across the independent claims, the main inventive coverage is the combination of a perfusion bioreactor for high cell density growth, a fluid connection to a downstream unit for producing antibodies and vaccines, delivery of both cell medium and gas or gaseous mixture via a single supply line, and an architecture that is implemented in a portable clean room and/or devoid of a recirculation loop.
Stated Advantages
Lower purified water use.
Lower CAPEX/OPEX, claimed to be 5–6× cheaper than large-scale systems.
Enabling manufacturing outside large facilities.
Reduction of contamination risk.
Higher yield.
Documented Applications
Producing an RSV-antibody vaccine formulation (described as SYNAGIS®-like products).
Interested in licensing this patent?