Multidimensional LC Workflow for Single-Sample Antibody Characterization
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Solution Overview
Problem
Current methods for characterizing therapeutic monoclonal antibodies (mAbs) at native, reduced, and peptide levels are time-consuming and labor-intensive due to the need for separate measurement protocols, which can lead to user errors and sample contamination.
Innovation Solution
A multidimensional LC system that integrates fractionation, reduction, and digestion modules to process a single sample into native, reduced, and peptide mapping samples sequentially, reducing user input and minimizing contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If separate measurement protocols are used for native, reduced, and peptide level analysis, then measurement precision is improved, but loss of time and loss of substance increase
Solution Approach 1:
The patent combines three separate measurement protocols (native level, reduced level, and peptide level analysis) into a single integrated multidimensional LC system. The system merges fractionation, reduction, and digestion modules into one platform that processes a single sample through all three measurement levels sequentially, eliminating the need for separate manual protocols and reducing overall analysis time while maintaining measurement precision.
Solution Approach 2:
The multidimensional LC system is designed as a universal platform that performs multiple functions: it conducts fractionation, reduction, and digestion operations within a single system. This multi-functional design allows the same instrument to complete all three measurement levels (native, reduced, and peptide) from one sample injection, reducing time loss and sample consumption compared to using separate dedicated instruments for each measurement type.
2Measurement precision
If separate measurement protocols are used for native, reduced, and peptide level analysis, then measurement precision is improved, but device complexity and ease of operation worsen
Solution Approach 1:
The patent merges three separate measurement systems into one integrated multidimensional LC platform. By combining the fractionation module, reduction module, and digestion module into a single system with automated sample processing, the patent reduces the operational complexity that would otherwise arise from managing multiple separate instruments and protocols, while maintaining the precision needed for comprehensive antibody characterization.
3Ease of operation
If manual sample preparation and measurement are performed, then ease of operation is improved, but loss of time and reliability worsen
Solution Approach 1:
The multidimensional LC system performs automated sample preparation and processing without requiring manual intervention at each step. The system automatically executes fractionation, reduction, and digestion operations, as well as sample injection and data analysis. This automation maintains operational simplicity while significantly improving reliability by eliminating user errors, contamination risks, and variability associated with manual handling, thereby increasing measurement reliability.
4Measurement precision
If multiple separate measurement steps are performed, then measurement precision is improved, but productivity worsens
Solution Approach 1:
The patent integrates three separate measurement steps (native level analysis, reduced level analysis, and peptide level analysis) into a single sequential process within one multidimensional LC system. By merging these steps into one automated workflow that processes a single sample through all measurement levels without requiring separate manual interventions, the system maintains high measurement precision while significantly improving productivity and analysis throughput.
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 provides efficient and accurate characterization of antibodies on multiple levels with reduced hands-on time, comparable to separate methods, while minimizing user errors and sample contamination.
Implementation Method 1
a reduction module having a reduction column fluidly connectable to the second outlet of the first splitter
Implementation Method 2
a digestion module having a digestion column containing an immobilised proteolytic enzyme for digesting the reduced sample
Implementation Method 3
a fractionation module having a fractionation column for providing fractionated samples
Data Source
AI summary
The invention related to a multidimensional LC system for analysing antibodies. The system provides multiple different measurement samples from a single sample, for example, the system may provide a native antibody sample for measurement, a reduced antibody sample for measurement and digested sample for peptide mapping from a single sample. The system has a fractionation module, a reduction module, a digestion module, a separation module and at least a first and a second splitter for splitting the flow.