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Publication Number
US-11809172-B2
Publication Date
2023-11-07
Expiration Date
Abstract
An integrated platform system controlled with hardware and software for just-in-time, local manufacturing is disclosed. System hardware may include a fermentation system, a cross-flow system, a disposable formulation system, a robotic fill-finish system, and a quality control test and release system.
Core Innovation
The invention provides a modular system for just-in-time manufacturing of a plurality of biologicals. The system includes a supervisory control system that executes software adapted to manufacture a desired biological and obtains manufacturing instructions from a batch manufacturing records database that stores a plurality of instructions for manufacturing different biologicals.
The system further includes a plurality of different plug-in-play manufacturing modules, with at least one of the plug-in-play manufacturing modules coupled to the system based on the desired biological. The supervisory control system determines what plug-in-play manufacturing modules are coupled to the system and controls flow of matter through each of the plug-in-play manufacturing modules coupled to the system based on the instructions for manufacturing the desired biological.
The disclosed platform integrates manufacturing modules including upstream and downstream unit operations, a robotic fill-finish system, and a quality control test and release system. Software supports closed-system, CFR 21 compliance guidance and uses a master recipe of steps and a tamper-proof Batch Manufacturing Records database. The disclosure describes plug-and-play operation for selecting modules to produce desired biologicals such as multiple vaccine types, with scalability including horizontal selection via plug-and-play and vertical scalability by increasing bioreactor scale.
The disclosure describes supervisory validation of produced biologicals and an alert system indicating process breakdowns and transmitting instructions to correct them. An example timeline includes upstream processing and downstream processing, robotic aseptic fill-finish, and quality control release within weeks, and indicates manufacturing less than 5 weeks.
Claims Coverage
The partial content provides one independent claim. The independent claim covers a supervisory control system that retrieves manufacturing instructions from a batch manufacturing records database and uses those instructions to select plug-in-play manufacturing modules and control matter flow through the coupled modules to manufacture a desired biological.
Supervisory control using manufacturing instructions
A supervisory control system executes software adapted to manufacture a desired biological, wherein the supervisory control system obtains instructions for manufacturing the desired biological from a batch manufacturing records database.
Tamper-proof batch manufacturing records database with instructions for different biologicals
A batch manufacturing records database in communication with the supervisory control system stores a plurality of instructions for manufacturing different biologicals.
Plug-in-play modular selection based on desired biological
A plurality of different plug-in-play manufacturing modules, wherein at least one of the plurality of different plug-in-play manufacturing modules is coupled to the system based on the desired biological, and wherein the supervisory control system determines what plug-in-play manufacturing modules are coupled to the system.
Controlling matter flow through coupled plug-in-play modules
The supervisory control system controls flow of matter through each of the plug-in-play manufacturing modules coupled to the system based on the instructions for manufacturing the desired biological.
Across the independent claim, inventive coverage centers on closed-loop control where the supervisory control system retrieves manufacturing instructions from the batch manufacturing records database, selects plug-in-play manufacturing modules according to the desired biological, and controls flow of matter through the coupled modules to manufacture the desired biological on a just-in-time modular basis.
Stated Advantages
Enables just-in-time manufacturing of a plurality of biologicals using a modular system with plug-in-play unit selection based on a desired biological.
Automates manufacturing module selection and controls flow of matter through coupled modules based on manufacturing instructions stored in a batch manufacturing records database.
Supports manufacturing time constraints including manufacturing less than 5 weeks.
Provides supervisory validation of produced biologicals.
Provides an alert system indicating process breakdowns and transmitting instructions to correct them.
Documented Applications
Production of multiple vaccine types using a just-in-time local modular bioprocess plant platform.
Use of a modular system to manufacture a plurality of biologicals by selecting plug-in-play manufacturing modules and controlling matter flow.
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