A Manufacturing Facility for the Production of Biopharmaceuticals
AssigneeLonza Ltd.
InventorAtul MOHINDRA
Life of this patent
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Abstract
A manufacturing facility for the continuous production of biopharmaceuticals integrated with single-use disposable technology.
Claims46
A manufacturing system for biopharmaceuticals comprising:
- at least one inputting device connected to at least one inoculum expansion device through at least one piece of tubing and a connector;
- said at least one inoculum expansion device is connected to at least one production stage bioreactor device through at least one piece of tubing and a connector;
- said at least one production stage bioreactor device is connected to at least one primary recovery device through at least one piece of tubing and a connector,
- said at least one primary recovery device is connected to at least one capturing device through at least one piece of tubing and a connector;
- said at least one capturing device is connected to at least one ultrafiltration and diafiltration device through at least one piece of tubing and a connector,
- said at least one ultrafiltration and diafiltration device is connected to at least one polishing membranes device through at least one piece of tubing and a connector,
- said at least one polishing membranes device is connected to at least one polishing using cation exchange device through at least one piece of tubing and a connector;
- said at least one polishing using cation exchange device is connected to at least one virus reduction filtration device through at least one piece of tubing and a connector;
- and
- said at least one virus reduction filtration device is connected to at least one ultrafiltration and diafiltration device through at least one piece of tubing and a connector;
- said at least one ultrafiltration and diafiltration device is connected to at least one automated bulk fill device through at least one piece of tubing and a connector.
A method of making biopharmaceuticals comprising:
- connecting at least one inputting device to at least one inoculum expansion device using at least one piece of tubing and a connector such that material can pass from the inputting device to the inoculum expansion device;
- connecting said at least one inoculum expansion device to at least one production stage bioreactor device using at least one piece of tubing and a connector such that material can pass from the inoculum expansion device to the production stage bioreactor device;
- connecting said at least one production stage bioreactor device to at least one primary recovery device using at least one piece of tubing and a connector such that material can pass from the production stage bioreactor device to the primary recovery device;
- connecting said at least one primary recovery device to at least one capturing device using at least one piece of tubing and a connector such that material can pass from the primary recovery device to the capturing device;
- connecting said at least one capturing device to at least one ultrafiltration and diafiltration device using at least one piece of tubing and a connector such that material can pass from the capturing device to the ultrafiltration and diafiltration device;
- connecting said at least one ultrafiltration and diafiltration device to at least one polishing membranes device using at least one piece of tubing and a connector such that material can pass from the ultrafiltration and diafiltration device to the polishing membrane device;
- connecting said at least one polishing membranes device to at least one polishing using cation exchange device using at least one piece of tubing and a connector such that material can pass from the polishing membranes device to the polishing using cation exchange device;
- and
- connecting said at least one polishing using cation exchange device to at least one virus reduction filtration device using at least one piece of tubing and a connector such that material can pass from the polishing using cation exchange device to the virus reduction filtration device.
A method of making biopharmaceuticals comprising:
- connecting at least one inputting device to at least one inoculum expansion device using at least one piece of tubing and a connector such that material can pass from the inputting device to the inoculum expansion device.
A manufacturing system for biopharmaceuticals comprising:
- at least one inputting device connected to at least one inoculum expansion device through at least one piece of tubing and a connector;
- said at least one inoculum expansion device is connected to at least one production stage perfusion device through at least one piece of tubing and a connector;
- said at least one production stage perfusion device is connected to at least one volume exchange device through at least one piece of tubing and a connector,
- said at least one volume exchange device is connected to at least one continuous filtration device through at least one piece of tubing and a connector,
- said at least one continuous filtration device is connected to at least one virus reduction filtration device through at least one piece of tubing and a connector;
- said at least one virus reduction filtration device is connected to at least one ultrafiltration and diafiltration device through at least one piece of tubing and a connector;
- and
- said at least one ultrafiltration and diafiltration device is connected to at least one automated bulk fill device through at least one piece of tubing and a connector.
A method of making biopharmaceuticals comprising:
- connecting at least one inputting device to at least one inoculum expansion device using at least one piece of tubing and a connector such that material can pass from the inputting device to the inoculum expansion device;
- connecting said at least one inoculum expansion device to at least one production stage perfusion device using at least one piece of tubing and a connector such that material can pass from the inoculum expansion device to the production stage perfusion device;
- connecting said at least one production stage perfusion device to at least one volume exchange device using at least one piece of tubing and a connector such that material can pass from the production stage perfusion device to the volume exchange device;
- connecting said at least one volume exchange device to at least one continuous purification device using at least one piece of tubing and a connector such that material can pass from the volume exchange device to the continuous purification device;
- connecting said at least one continuous purification device to at least one virus reduction filtration device using at least one piece of tubing and a connector such that material can pass from the continuous purification device to the virus reduction filtration device;
- connecting said at least one virus reduction filtration device to at least one ultrafiltration and diafiltration device using at least one piece of tubing and a connector such that material can pass from the virus reduction filtration device to the ultrafiltration and diafiltration device;
- and
- connecting said at least one ultrafiltration and diafiltration device to at least one automated bulk fill device using at least one piece of tubing and a connector such that material can pass from the ultrafiltration and diafiltration device to the automated bulk fill device.
A manufacturing system for biopharmaceuticals comprising:
- at least one inputting device connected to at least one inoculum expansion device through at least one piece of tubing and a connector,
- said at least one inoculum expansion device is connected to at least one production stage bioreactor device through at least one piece of tubing and a connector;
- said at least one production stage bioreactor device is connected to at least one primary recovery device through at least one piece of tubing and a connector;
- said at least one primary recovery device is connected to at least one volume exchange device through at least one piece of tubing and a connector,
- said at least one volume exchange device is connected to at least one continuous purification device through at least one piece of tubing and a connector;
- said at least one continuous purification device is connected to at least one virus reduction filtration device through at least one piece of tubing and a connector;
- said at least one virus reduction filtration device is connected to at least one ultrafiltration and diafiltration device through at least one piece of tubing and a connector;
- and
- said at least one ultrafiltration and diafiltration device is connected to at least one automated bulk fill device through at least one piece of tubing and a connector.
A method of making biopharmaceuticals comprising:
- connecting at least one inputting device to at least one inoculum expansion device using at least one piece of tubing and a connector such that material can pass from the inputting device to the inoculum expansion device;
- connecting said at least one inoculum expansion device to at least one production stage bioreactor device using at least one piece of tubing and a connector such that material can pass from the inoculum expansion device to the production stage bioreactor device;
- connecting said at least one production stage bioreactor device to at least one primary recovery device using at least one piece of tubing and a connector such that material can pass from the production stage bioreactor device to the primary recovery device;
- connecting said at least one primary recovery device to at least one volume exchange device using at least one piece of tubing and a connector such that material can pass from the primary recovery device to the volume exchange device;
- connecting said at least one volume exchange device to at least one continuous purification device using at least one piece of tubing and a connector such that material can pass from the volume exchange device to the continuous purification device;
- connecting said at least one continuous purification device to at least one virus reduction filtration device using at least one piece of tubing and a connector such that material can pass from the continuous purification device to the virus reduction filtration device;
- connecting said at least one virus reduction filtration device to at least one ultrafiltration and diafiltration device using at least one piece of tubing and a connector such that material can pass from the virus reduction filtration device to the ultrafiltration and diafiltration device;
- and
- connecting said at least one ultrafiltration and diafiltration device to at least one automated bulk fill device using at least one piece of tubing and a connector such that material can pass from the ultrafiltration and diafiltration device to the automated bulk fill device.
A manufacturing system for biopharmaceuticals comprising:
- at least one inputting device connected to at least one inoculum expansion device through at least one piece of tubing and a connector,
- said at least one inoculum expansion device is connected to at least one production stage perfusion device through at least one piece of tubing and a connector,
- said at least one production stage perfusion device is connected to at least one volume exchange device through at least one piece of tubing and a connector;
- said at least one volume exchange device is connected to at least one continuous purification device through at least one piece of tubing and a connector;
- said at least one continuous purification device is connected to at least one virus reduction filtration device through at least one piece of tubing and a connector;
- said at least one virus reduction filtration device is connected to at least one ultrafiltration and diafiltration device through at least one piece of tubing and a connector;
- and
- said at least one ultrafiltration and diafiltration device is connected to at least one automated bulk fill device through at least one piece of tubing and a connector.
A method for manufacturing biopharmaceuticals comprising:
- connecting at least one inputting device to at least one inoculum expansion device using at least one piece of tubing and a connector such that material can pass from the inputting device to the inoculum expansion device;
- connecting said at least one inoculum expansion device to at least one production stage bioreactor device using at least one piece of tubing and a connector such that material can pass from the inoculum expansion device to the production stage bioreactor device;
- connecting said at least one production stage bioreactor device to at least one primary recovery device using at least one piece of tubing and a connector such that material can pass from the production stage bioreactor device to the primary recovery device;
- connecting said at least one primary recovery device to at least one volume exchange device using at least one piece of tubing and a connector such that material can pass from the primary recovery device to the volume exchange device;
- connecting said at least one volume exchange device to at least one continuous purification device using at least one piece of tubing and a connector such that material can pass from the volume exchange device to the continuous purification device;
- connecting said at least one continuous purification device to at least one virus reduction filtration device using at least one piece of tubing and a connector such that material can pass from the continuous purification device to the virus reduction filtration device;
- connecting said at least one virus reduction filtration device to at least one ultrafiltration and diafiltration device using at least one piece of tubing and a connector such that material can pass from the virus reduction filtration device to the ultrafiltration and diafiltration device;
- and
- connecting said at least one ultrafiltration and diafiltration device to at least one automated bulk fill device using at least one piece of tubing and a connector such that material can pass from the ultrafiltration and diafiltration device to the automated bulk fill device.
A manufacturing system for biopharmaceuticals comprising:
- at least one inputting device connected to at least one inoculum expansion device through at least one piece of tubing and a connector.
A method to manufacture a biopharmaceutical product comprising:
- inserting a material into an inoculum device for processing;
- transferring the material from the inoculum device to an inoculum expansion device for further processing;
- then transferring the material from the inoculum expansion device to a production stage bioreactor device for further processing;
- then transferring the material from the production stage bioreactor device to a primary recovery device for further processing;
- then transferring the material from the primary recovery device to a capturing device for further processing;
- then transferring the material from the capturing device to an ultrafiltration and diafiltration device for further processing;
- then transferring the material from the ultrafiltration and diafiltration device to a polishing membrane device for further processing;
- then transferring the material from the polishing membrane device to a polishing using cation exchange device for further processing;
- then transferring the material from the polishing using cation exchange device to a virus reduction filtration device for further processing;
- then transferring the material from the virus reduction filtration device to an ultrafiltration and diafiltration device for further processing;
- and
- then transferring the material from the ultrafiltration and diafiltration device to an automated bulk fill device to obtain the biopharmaceutical product.
A method to manufacture a biopharmaceutical product comprising:
- inserting a material into an inoculum device for processing;
- transferring the material from the inoculum device to an inoculum expansion device for further processing;
- then transferring the material from the inoculum expansion device to a production stage perfusion device for further processing;
- then transferring the material from the production stage perfusion device to a volume exchange device for further processing;
- then transferring the material from the volume exchange device to a continuous filtration device for further processing;
- then transferring the material from the continuous filtration device to a virus reduction filtration device for further processing;
- then transferring the material from the virus reduction filtration device to an ultrafiltration and diafiltration device for further processing;
- and
- then transferring the material from the ultrafiltration and diafiltration device to an automated bulk fill device to obtain the biopharmaceutical product.
A method to manufacture a biopharmaceutical product comprising:
- inserting a material into an inoculum device for processing;
- transferring the material from the inoculum device to an inoculum expansion device for further processing;
- then transferring the material from the inoculum expansion device to a production stage bioreactor device for further processing;
- then transferring the material from the production stage bioreactor device to a primary recovery device for further processing;
- then transferring the material from the primary recovery device to a volume exchange device for further processing;
- then transferring the material from the volume exchange device to a continuous purification device for further processing;
- then transferring the material from the continuous purification device to a virus reduction filtration device for further processing;
- then transferring the material from the virus reduction filtration device to an ultrafiltration and diafiltration device for further processing;
- and
- then transferring the material from the ultrafiltration and diafiltration device to an automated bulk fill device to obtain the biopharmaceutical product.
A method to manufacture a biopharmaceutical product comprising:
- inserting a material into an inoculum device for processing;
- transferring the material from the inoculum device to an inoculum expansion device for further processing;
- then transferring the material from the inoculum expansion device to a production stage perfusion device for further processing;
- then transferring the material from the production stage perfusion device to a volume exchange device for further processing;
- then transferring the material from the volume exchange device to a continuous purification device for further processing;
- then transferring the material from the continuous purification device to a virus reduction filtration device for further processing;
- then transferring the material from the virus reduction filtration device to an ultrafiltration and diafiltration device for further processing;
- and
- then transferring the material from the ultrafiltration and diafiltration device to an automated bulk fill device to obtain the biopharmaceutical product.
Dependencies are inferred from the claim text.