Recombinant PLA2R Antibody Standard for Absolute Quantification
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Solution Overview
Problem
Current PLA2R antibody diagnostic kits use human serum as a standard, which limits absolute quantification, is prone to pathogen contamination, and results in batch differences due to varied antibody sources, affecting clinical accuracy and increasing production costs.
Innovation Solution
Development of a recombinant anti-human PLA2R antibody or its antigen-binding fragment with high affinity to PLA2R protein, produced through mammalian cell expression, ensuring stable and large-scale production, reducing contamination risks, and minimizing batch variations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If human serum is used as the standard, then the standard can be obtained from patient samples, but absolute quantification is impossible and only relative units can be obtained
Solution Approach 1:
The patent creates a recombinant antibody standard that copies the essential binding characteristics of patient-derived PLA2R antibodies without using actual human serum. The recombinant antibody is produced in mammalian cells with standardized characteristics, enabling absolute quantification while maintaining diagnostic relevance through consistent affinity and specificity for PLA2R.
Solution Approach 2:
The patent changes the fundamental parameter of the standard from biological variability (human serum from different patients) to controlled reproducibility (recombinant antibody produced in mammalian cells). This parameter change enables precise control over concentration, affinity, and batch consistency, achieving absolute quantification capability.
2Reliability
If human serum standard is used, then the standard reflects clinical samples, but pathogen contamination risk cannot be ruled out
Solution Approach 1:
The recombinant antibody standard copies the diagnostic functionality of patient antibodies without incorporating any pathogen contamination risk. Produced through controlled recombinant DNA technology in mammalian cells, the standard maintains clinical relevance while eliminating the harmful factor of pathogen contamination inherent in human serum standards.
Solution Approach 2:
The patent uses recombinant DNA technology as an intermediary between the clinical sample (patient antibody) and the standard. This intermediary process isolates the useful binding function while removing all biological contaminants, creating a safe and reliable standard.
3Manufacturing precision
If human serum standard is used, then the standard can be prepared from patient samples, but batch differences occur due to varied antibody sources
Solution Approach 1:
The recombinant antibody standard copies the essential binding properties of patient antibodies while eliminating the source variability. Produced through standardized recombinant DNA technology in mammalian cells, the standard achieves consistent batch-to-batch performance and scalable production, resolving the contradiction between precision and manufacturability.
Solution Approach 2:
The patent changes the production parameter from uncontrolled biological variation (patient-to-patient antibody differences) to controlled molecular biology parameters (recombinant DNA sequencing, cell culture conditions). This enables precise control over batch consistency and scalable manufacturing.
4Reliability
If human serum standard is used, then the standard reflects real patient antibodies, but production cost increases due to limited sources
Solution Approach 1:
The recombinant antibody standard copies the clinical relevance of patient antibodies without the cost constraints of collecting and processing human serum. The standardized production process in mammalian cells enables cost-effective scaling while maintaining diagnostic accuracy, resolving the contradiction between reliability and manufacturing cost.
Data Source
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AI summary
Provided are a human anti-human PLA2R antibody or an antigen-binding fragment thereof. The antibody or the antigen-binding fragment thereof includes at least one CDR sequence selected from the following amino acid sequences or amino acid sequences having at least 80% identity thereto: a heavy chain variable region CDR sequence selected from SEQ ID NO: 1 to SEQ ID NO: 105; and a light chain variable region CDR sequence selected from SEQ ID NO: 106 to SEQ ID NO: 210.