Disposable Bioprocess Module for Real-Time Protein Monitoring
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Solution Overview
Problem
In bioprocesses, monitoring protein concentration in real-time is challenging due to the need for manual sample transport to distant quality control labs, leading to delayed analysis and potential contamination risks, especially since current methods require skilled personnel and involve time-consuming cleaning procedures for disposable devices.
Innovation Solution
A disposable, single-use module with a valve, filter, and flow cell that can be directly connected to a bioreactor for real-time protein concentration monitoring using UV light, allowing for quick analysis and easy disposal, reducing contamination risks and simplifying the changeover process between batches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If samples are manually transported to distant quality control labs for analysis, then analysis can be performed with skilled personnel, but analysis time is delayed and contamination risks increase
Solution Approach 1:
The system divides the analysis function into a portable module that can be positioned near the bioreactor, separating the sampling location from the distant quality control lab while maintaining analysis capability
Solution Approach 2:
A portable analysis module serves as an intermediary between the bioreactor and the main quality control lab, enabling on-site analysis without requiring manual sample transport to distant facilities
2Reliability
If disposable devices are used to eliminate contamination risks, then cleaning time and complexity are reduced, but device disposal increases cost
Solution Approach 1:
The disposable module is designed to perform multiple functions (sampling, filtering, UV analysis) in a single integrated unit, maximizing the value of each disposable device while eliminating contamination risks
Solution Approach 2:
The system uses disposable modules that can be discarded after a single use, eliminating the need for expensive and time-consuming cleaning procedures while preventing cross-contamination between batches
3Reliability
If manual cleaning procedures are implemented for disposable devices, then contamination risks are reduced, but changeover time between batches increases
Solution Approach 1:
The system employs disposable modules that are discarded after single use, completely eliminating the need for cleaning procedures between batches and enabling immediate changeover
Solution Approach 2:
Instead of cleaning and reusing expensive equipment, the system discards disposable modules after use and replaces them with fresh ones, significantly reducing changeover time while ensuring complete cleanliness
4Measurement precision
If skilled personnel with advanced degrees perform analysis, then measurement accuracy is maintained, but operational complexity and training requirements increase
Solution Approach 1:
The portable module performs UV-based protein concentration analysis automatically without requiring skilled personnel to manually operate complex instrumentation, making the system easy to use while maintaining measurement accuracy
Solution Approach 2:
The system replaces complex manual analysis procedures requiring skilled operators with automated UV spectroscopy that can be operated by less trained personnel, maintaining precision while simplifying operation
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 real-time monitoring of protein concentration, reduces analysis delays, minimizes contamination risks, and streamlines the changeover process between batches, improving production efficiency and product quality.
Implementation Method 1
The flow cell may use UV light to determine a protein concentration of a sample
Data Source
AI summary
Apparatus and methods for providing a single-use, disposable module or manifold for testing and analysis of bioprocesses, as well as a portable and compact device which can be used with the module or manifold. A module comprising a valve, a filter or guard column, an affinity column, and a flow cell is provided with several ports for receiving tubing connections for a sample and one or more solvents, as well as one or more outlet ports for connections to one or more waste reservoirs. The flow cell may use UV light to determine a protein concentration of a sample in one particular example. The module can be connected directly or indirectly to a bioreactor containing the bioprocess and material to be sampled, and can be disposed of once a production run has been completed. In addition, manifolds are provided which can be embodied as a valve assembly, and which can comprise the same components and features as the disposable module. The manifolds and modules are compact and easy to use. A portable device adapted for use with a easily removable module is also provided.