System and method for manufacturing
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Solution Overview
Problem
Bio/pharmaceutical manufacturing faces challenges with high capital investment costs, inflexible infrastructure, and difficulties in predicting production capacity due to uncertainties in drug development timelines and market demand, leading to inefficient and costly manufacturing processes.
Innovation Solution
A flexible manufacturing platform using portable, controlled-environment modules with disposable components, automation, and electronic batch control, allowing for rapid reconfiguration and concurrent operation of multiple manufacturing stages in a common unclassified space, reducing the need for clean-in-place and sterilization operations and minimizing manual errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional stainless steel vessels and piping are used for bio-manufacturing, then manufacturing quality and reliability are maintained, but capital investment cost and device complexity increase significantly
Solution Approach 1:
The patent employs single-use disposable bioreactor bags and associated consumables (tubing, filters, connectors) that are discarded after one use, eliminating the need for expensive stainless steel vessels and complex clean-in-place/steam-in-place systems. This disposable approach maintains manufacturing quality through validated single-use components while dramatically reducing infrastructure complexity and capital investment.
2Reliability
If traditional stainless steel vessels with clean-in-place and steam-in-place systems are used, then manufacturing reliability is ensured, but manufacturing time and loss of time increase due to extensive cleaning and sterilization procedures
Solution Approach 1:
Single-use disposable bioreactor bags eliminate the time-consuming clean-in-place and steam-in-place procedures required for reusable stainless steel vessels. Each disposable bag is pre-sterilized and ready for immediate use, allowing rapid setup and teardown while maintaining manufacturing quality through validated single-use components.
Solution Approach 2:
The disposable bioreactor bags are pre-sterilized and pre-prepared before use, eliminating the need for on-site cleaning and sterilization procedures. This preliminary preparation allows the manufacturing process to begin immediately without the time loss associated with traditional cleaning and sterilization cycles.
3Reliability
If traditional stainless steel vessels are used, then manufacturing reliability is maintained, but ease of manufacture and adaptability decrease due to difficulty in reconfiguration for new processes
Solution Approach 1:
Disposable bioreactor bags are inherently adaptable to different processes and products since each bag is a standalone unit that can be configured for specific applications. Changing from one product to another simply requires replacing the disposable bag rather than reconfiguring permanent stainless steel infrastructure, thereby maximizing adaptability while maintaining manufacturing quality.
Solution Approach 2:
The manufacturing system is segmented into independent disposable bioreactor bags that can be individually selected and configured for different processes. This segmentation allows easy reconfiguration for new products by simply replacing individual bags rather than reconfiguring an integrated stainless steel system, enhancing adaptability while preserving quality control.
4Reliability
If multiple parallel clean room suites are built for multiple product manufacturing, then product quality is maintained, but capital investment cost and device complexity increase
Solution Approach 1:
Single-use disposable bioreactor bags enable multiple products to be manufactured in a single controlled environment without cross-contamination risks. Each disposable bag is independently sealed and sterilized, allowing parallel processing of multiple products in one facility rather than requiring multiple separate clean room suites, thereby reducing facility complexity and capital investment.
Solution Approach 2:
The patent merges multiple product manufacturing capabilities into a single controlled environment by using disposable bioreactor bags that prevent cross-contamination. This consolidation eliminates the need for multiple separate clean room suites with their own HVAC systems and access corridors, reducing facility complexity while maintaining product quality.
Data Source
AI summary
Embodiments of the present invention are directed to a customizable bio-manufacturing system which includes a manufacturing space having a first air handling system for providing supply air and a second air handling system for handling exhaust air, the supply air system being optionally provided with at least one of filtration, heating, cooling and or humidity control and a plurality of portable modules provided within the manufacturing space. At least one module having an interior capable of being interconnected with another module interior and each module's interior includes one or more components to perform at least one specific task of a biological, chemical, and/or pharmaceutical manufacturing process. At least one module includes an on-board environmental control system for controlling an environment within the module and a connection means for interconnecting the module interior with another module interior. The system also includes a central controller operating to at least perform one or more of operation and information collection for the operation of at least one of the system and one or more modules.