Bioprocess Filtration Module With Integrated Sampling Membrane
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Solution Overview
Problem
Current biopharmaceutical processes lack the capability for real-time, on-line or in-line measurement of analytes or parameters during process steps, leading to potential inefficiencies and contamination risks during sampling.
Innovation Solution
A filtration module with a process flow path and coupled filter and sampling membranes allows for continuous sampling and analysis of process media without interrupting the filtration process, using sampling membranes with specific molecular weight cut-offs to extract targeted analytes directly to an integrated or external analyzer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional sampling methods are used during bioprocess filtration, then samples can be obtained for analysis, but the process must be interrupted and contamination risks increase
Solution Approach 1:
The filtration module is segmented into separate functional zones: a main filtration chamber and a sampling chamber divided by a sampling membrane. This allows continuous filtration in the main chamber while enabling separate, controlled sampling operations without interrupting the overall process or exposing the main process medium to contamination risks.
Solution Approach 2:
A sampling membrane acts as an intermediary barrier between the process medium and the sampling flow path. This membrane allows selective passage of analytes while maintaining physical separation, enabling sample extraction without direct contact between sampling equipment and the main process medium, thus preventing contamination.
2Productivity
If sampling is performed during filtration, then real-time process monitoring is enabled, but pressure loss occurs in the system
Solution Approach 1:
The sampling membrane extracts only the necessary analytes from the process medium for analysis, while the bulk process medium continues to flow through the filtration system under normal pressure conditions. This selective extraction enables monitoring without significantly impacting the overall pressure balance of the filtration process.
Solution Approach 2:
The sampling membrane has specific local properties (pore size, molecular weight cut-off) that allow it to selectively pass certain analytes while maintaining pressure for the bulk medium. This localized functional differentiation enables monitoring capability without compromising the pressure integrity of the main filtration system.
3Adaptability or versatility
If multiple analytes are monitored, then comprehensive process control is achieved, but device complexity increases
Solution Approach 1:
The sampling membrane is designed with universal characteristics (specific molecular weight cut-off) that enable it to simultaneously allow passage of multiple different analytes (e.g., glucose, lactate, amino acids, antibodies) based on their molecular sizes. This single membrane structure provides multi-analyte monitoring capability without requiring separate sampling paths for each analyte.
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
Enables automatic, quasi-continuous sampling and real-time analysis of process media, preventing contamination and pressure loss, allowing for immediate process adjustments without interrupting the filtration process.
Implementation Method 1
a sampling membrane coupled both to the process flow path and to the sampling flow path for extracting a sample from the process medium during the filtering process step of the bioprocess
Implementation Method 2
sampling membranes with specific molecular weight cut-offs to extract targeted analytes
Implementation Method 3
a filter membrane coupled to the process flow path for performing the filtering process step of the bioprocess
Data Source
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Figure 2a~2g
Figure 3a~3f
AI summary
A filtration module (20) for filtering a process medium in a bioprocess, in particular in a biopharmaceutical process comprises a process flow path for a process medium, a filter membrane (20) coupled to the process flow path, and a sampling membrane (18) coupled both to the process flow path and to a sampling flow path (16) for extracting a sample from the process medium. The sampling flow path (16) guides the extracted sample to a sampling outlet of the filtration module (20) or to an analyzer integrated into the filtration module (20). A filtration assembly comprises such a filtration device and an analyzer coupled to the sampling outlet of the filtration module (20). A method of sampling during a bioprocess comprises the following steps: providing such a filtration module (20); urging a process medium through the process flow path; filtering the process medium by using the filter membrane (20) coupled to the process flow path; extracting a sample from the process medium by using the sampling membrane (18) coupled to both the process flow path and the sampling flow path (16); and guiding the extracted sample to a sampling outlet of the filtration module (20) or to an analyzer integrated into the filtration module (20). A computer program comprises instructions to effect at least one of the following: cause the means for urging the transport medium through the sampling flow path (16) of the filtration assembly to control the flow of the transport medium; control the analyzer of the filtration module (20) or the analyzer of the filtration assembly, especially providing settings and inputs to the analyzer; cause a process control unit of the filtration assembly to evaluate analysis data provided by the analyzer of the filtration module or the analyzer of the filtration assembly, and to adjust or control the bioprocess based on the evaluation