HER3 Antibodies for FFPE Tissue Detection
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Solution Overview
Problem
Current antibodies fail to effectively detect the human HER3 protein in tissue samples, especially those that have been formalin-fixed and paraffin-embedded, due to lack of binding specificity and sensitivity, which is crucial for correlating structure and morphology with biological functions, particularly in cancer contexts.
Innovation Solution
Development of isolated antibodies with specific heavy and light chain variable domains, including CDR regions with modified amino acid sequences, that bind to human HER3, enabling effective immunohistochemical detection even in formalin-fixed paraffin-embedded tissue samples using automated staining systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional antibodies are used for HER3 detection, then the staining procedure can be performed, but the binding specificity and sensitivity are insufficient, especially for formalin-fixed paraffin-embedded tissue samples
Solution Approach 1:
The patent applies parameter changes by modifying the amino acid sequences in the CDR regions of the antibody variable domains. Specifically, the CDR1H, CDR2H, CDR3H, CDR1L, CDR2L, and CDR3L regions are engineered with optimized sequences to enhance binding affinity and specificity for HER3, thereby improving detection precision while maintaining binding reliability in formalin-fixed paraffin-embedded tissue samples
2Manufacturing precision
If existing anti-HER3 antibodies are used, then staining can be attempted, but the staining quality is poor with automated staining systems due to inadequate binding specificity
Solution Approach 1:
The patent optimizes the antibody parameters by engineering specific amino acid sequences in the CDR regions to enhance binding characteristics. This enables the antibody to perform reliably in automated staining systems without requiring complex protocol modifications, thereby improving staining quality while maintaining ease of use in automated platforms
3Measurement precision
If conventional antibodies are used for HER3 detection in tissue samples, then the procedure can be completed, but the sensitivity and specificity are insufficient for reliable detection
Solution Approach 1:
The patent addresses detection difficulty by engineering optimized amino acid sequences in all six CDR regions of the antibody. These parameter changes in the variable domains enhance the antibody's ability to specifically recognize and bind HER3 epitopes in tissue samples, thereby improving detection sensitivity and reducing the difficulty of obtaining reliable results
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 antibodies provide excellent staining results for human HER3 in formalin-fixed paraffin-embedded tissue samples, overcoming the limitations of existing antibodies by offering high binding specificity and sensitivity, facilitating reliable detection in both manual and automated immunohistochemical procedures.
Implementation Method 1
an isolated antibody, or an antigen binding portion thereof, which binds to human HER3
Data Source
AI summary
The present invention relates to isolated antibodies, or an antigen portions thereof, which bind to human HER3. The novel antibodies are of great utility since they allow for the sensitive and specific detection of human HER3. Detection of human HER3 is, e.g., possible in a tissue sample, even when such tissue sample is a formalin-fixed paraffin embedded tissue (FFPET) sample.