Disposable Bioprocess System for High Cell Density Perfusion
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Solution Overview
Problem
The pharmaceutical industry faces challenges in continuous processing of micro-organisms due to the lack of disposable, pre-sterilized bioprocess systems that integrate a single-use bioreactor, pump, and cell retention system, leading to issues with cross-contamination, high costs, and time-consuming sterilization processes.
Innovation Solution
A Disposable Bioprocess System comprising a Single-Use-Bioreactor, a Single-Use-Pump, and a single-use Cross-Flow-Filter, operating under Pulsating-Tangential-Flow mode, which eliminates the need for traditional sterilization, reduces contamination risks, and enables efficient micro-organism retention and perfusion mode operations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional re-usable bioreactors are used, then equipment durability and reusability are improved, but cross-contamination risk and sterilization time increase
Solution Approach 1:
The patent employs disposable single-use bioreactors made from flexible film materials that are pre-sterilized and designed for one-time use. These bioreactors are discarded after a single cultivation run, eliminating cross-contamination risks entirely while maintaining reliable performance during their service life. The disposable nature resolves the contradiction by sacrificing equipment reusability to achieve complete contamination prevention.
2Reliability
If traditional sterilization processes are applied, then microbial contamination is prevented, but processing time and operational complexity increase
Solution Approach 1:
The single-use bioreactors are pre-sterilized during manufacturing before being packaged and shipped to the user. This preliminary sterilization action eliminates the need for on-site sterilization processes, reducing operational time and complexity while ensuring reliable sterilization effectiveness. The bioreactor arrives ready-to-use with all sterilization already completed.
3Ease of operation
If disposable single-use bioreactors are used, then cross-contamination is eliminated and setup time is reduced, but integration of pump and cell retention system becomes more challenging
Solution Approach 1:
The patent integrates the pump, cell retention system, and bioreactor into a single unified disposable unit. All components are combined within one pre-sterilized flexible film structure, eliminating the need for separate sterilization and setup of individual components. This merging approach reduces overall setup time while managing integration complexity within the manufactured unit.
Solution Approach 2:
The integrated disposable system performs multiple functions within a single unit: cultivation, pumping, cell retention, and harvesting. This multi-functionality simplifies the overall system architecture by eliminating the need for separate re-usable equipment for each function, reducing setup complexity despite the advanced capabilities provided.
4Productivity
If high cell density cultivation is pursued, then productivity increases, but risk of contamination and equipment failure increases
Solution Approach 1:
The disposable bioreactor enables high cell density cultivation while maintaining low contamination risk through its single-use nature. The flexible film material provides excellent sealing properties that prevent contamination even under high cell density conditions. After one use, the entire system is discarded, eliminating any risk of contamination from previous cultures regardless of how high the cell density was.
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
This system allows for rapid evaluation of multiple micro-organism cultures, increases productivity, and reduces material and labor costs by providing a pre-assembled, pre-sterilized platform for continuous processing with improved volumetric efficiency and on-line analyst measures, enabling extended cultivation times and higher cell densities.
Implementation Method 1
operating under Pulsating-Tangential-Flow mode
Implementation Method 2
a single-use Cross-Flow-Filter
Data Source
AI summary
A Disposable Bioprocess System including a Single-Use-Bioreactor, a Single-Use-Pump and a single-use micro-organism retention filter. Combined most suitable for cultivation of suspended micro-organisms in a liquid media at high micro-organism concentration in a perfusion mode continuous process for expression of biological material. The inlet port of the liquid Single-Use-Pump connects via a valve to the broth reservoir of the Single-Use-Bioreactor through a liquid conveying port. The outlet port of the liquid pumping Single-Use-Pump connects via a valve to a micro-organism retention filter. And a method for operating said sterile Disposable Bioprocess System in perfusion mode for continuously processing.