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US 2019/0171188 A1Published application
Biopharmaceutical Batch Recipe Review by Exception
AssigneeLonza Ltd.
InventorLeslie Fister
Life of this patent
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Abstract
A biopharmaceutical manufacturing control system and associated methods are disclosed herein.
Claims18
A method of producing a biopharmaceutical, comprising:
- a) providing a first recipe step during biopharmaceutical manufacture to an operator;
- b) detecting an exception to the first recipe step;
- c) providing corrective action during biopharmaceutical manufacture to obviate the exception against acceptance criteria;
- d) confirming that the corrective action was implemented;
- and
- e) producing an automated batch record memorializing the corrective action taken.
3 more elements
A biopharmaceutical manufacturing control system, comprising:
- a manufacturing execution system;
- and
- an exception control module implemented on the manufacturing execution system that is configured to detect an exception to a process step prescribed by the manufacturing execution system and provide remedial action for the exception.
A manufacturing execution system, comprising:
- an exception control module.
Dependencies are inferred from the claim text.