Single-Use Filter Cart Switching Between Batch and Continuous Bioprocessing
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Solution Overview
Problem
Existing biologics manufacturing facilities face challenges in integrating upstream and downstream processes, particularly due to the dimensional limitations of chromatography columns, which are bottlenecks in purifying large product batch sizes, and there is a need for flexible and efficient filter systems that can handle both batch and continuous manufacturing processes.
Innovation Solution
A portable automated single-use filter cart system with interchangeable filtration paths and sensors that can switch between batch and continuous modes, featuring a controller for automated operation and interchangeable filtration modules, including depth and viral filters, to manage fluid flow and filtration based on real-time measurements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional batch processing platforms are used, then operational simplicity is maintained, but throughput and productivity are limited
Solution Approach 1:
The system is divided into discrete, modular units including upstream processing modules, downstream processing modules, and interchangeable filter carts. Each module can be independently configured and operated, allowing batch processes to be segmented into manageable stages that can be executed sequentially or in parallel, thereby increasing throughput without overwhelming operational complexity
Solution Approach 2:
The system incorporates dynamic configurability where filter carts can be interchangeably deployed between batch and continuous processing modes. The automated control system dynamically adjusts parameters and sequences based on the selected mode, enabling the same hardware platform to adapt to different productivity requirements without requiring complete system redesign
2Productivity
If continuous processing is implemented, then throughput and productivity increase, but process complexity and integration difficulty increase
Solution Approach 1:
The filter cart system is designed with universal applicability to serve multiple functions - it can be used in both batch and continuous processing modes, and can be interchangeably deployed in different positions within the processing train. This multi-functionality allows continuous processing implementation without sacrificing integration flexibility, as the same components can be reconfigured for different operational requirements
Solution Approach 2:
The system introduces intermediary buffer vessels and connecting manifolds that facilitate the transition between continuous and batch modes. These intermediaries act as buffers that decouple the upstream and downstream processing, allowing continuous operation to be maintained while providing points of flexibility for integration and configuration changes
3Quantity of substance
If chromatography column dimensions are increased to handle larger batch sizes, then purification capacity improves, but facility footprint and space requirements increase
Solution Approach 1:
Instead of increasing chromatography column dimensions in a single dimension, the system transitions to a different dimensional approach by implementing continuous processing with multiple smaller columns operating in parallel or sequence. This allows the same total purification capacity to be achieved with a smaller footprint by utilizing time as an additional dimension - processing continues uninterrupted while columns are regenerated or switched
4Adaptability or versatility
If filter systems are designed for indefinite switching between paths, then operational flexibility and adaptability improve, but device complexity increases
Solution Approach 1:
The filtration system is segmented into discrete, independently controllable filter units with dedicated inlet and outlet manifolds. Each filter cart can be individually switched in or out of the flow path, allowing operational flexibility to be achieved through simple on/off control of individual segments rather than complex integrated switching mechanisms
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system enables flexible and efficient filtration processes, supporting indefinite switching between filtration paths and accommodating extended production periods, thereby enhancing the integration of upstream and downstream processes in biologics manufacturing.
Implementation Method 1
a plurality of filters downstream from the first pump, wherein the plurality of filters is fluidly connected in sequence along the filtration path
Data Source
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AI summary
Disclosed is a portable automated single-use filter cart system for interchangeable continuous or batch biologies manufacturing processes.