Kappa/Lambda Fab-Fab Structure for Bispecific Antibody Pairing

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Solution Overview

Problem

Current methods for developing bispecific antibodies face challenges in achieving functional molecules with correct chain combinations, particularly in IgG-like structures, leading to issues such as chain-mismatching, instability, and reduced serum half-life, which complicates production and limits application scenarios.

Innovation Solution

A 'κ/λ' Fab-Fab structure is designed for bispecific antibodies, maintaining the Fab structure without introducing scFv, allowing high spatial freedom for antigen-binding, and enabling efficient purification and scalability, with optional linker peptides and a half-life extension module.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If IgG-like antibody structures containing Fc are used for bispecific antibodies, then the serum half-life is extended through FcRn binding, but chain-mismatching problems occur due to the complexity of combining two different heavy chains and two different light chains

Engineering Contradiction:
Improveserum half-lifeVSAvoidchain combination correctness
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent divides the antibody structure into separate Fab and Fc components. The Fab regions containing the antigen-binding sites are designed as independent modules that can be systematically combined with Fc regions, reducing the complexity of chain pairing and minimizing chain-mismatching issues while preserving Fc-mediated half-life extension.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a hinge region as an intermediary component that connects the Fab and Fc regions. This hinge region serves as a standardized interface that facilitates proper assembly of the antibody chains and ensures correct pairing between heavy and light chains, thereby improving reliability in chain combination.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If antibody fragment structures without Fc are used for bispecific antibodies, then chain-mismatching is reduced by simplifying the structure, but the serum half-life is reduced due to loss of FcRn binding

Engineering Contradiction:
Improvechain combination correctnessVSAvoidserum half-life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent merges the advantages of both antibody fragment and full IgG structures by combining Fab regions (which simplify chain pairing) with Fc regions (which provide half-life extension). This creates a hybrid structure that achieves both reduced chain-mismatching and extended serum half-life simultaneously.

Inventive Principle:
Principle #5Merging (Combining)

3Adaptability or versatility

If scFv structures are introduced to create bispecific antibodies, then the structural design flexibility is improved, but the antigen-binding specificity and function are compromised due to the engineered nature of scFv

Engineering Contradiction:
Improvestructural design flexibilityVSAvoidantigen-binding specificity
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent uses conventional IgG antibodies as ready-made, well-characterized building blocks rather than engineering new scFv structures. This approach leverages the proven antigen-binding specificity of natural antibodies while using modular assembly to achieve the desired bispecific functionality, thereby maintaining high binding reliability.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Data Source

PatentEP4640700A1"kappa/lambda" fab-fab series-connection multi-specific binding protein, preparation thereof, and use thereof
Publication Date: 2025.10.29 HARBOUR BIOMED (SHANGHAI) CO LTD
  • EP4640700A1 patent drawingFigure 1~2
  • EP4640700A1 patent drawingFigure 3(A)~3(B)
  • EP4640700A1 patent drawingFigure 4(A)~4(B)

AI summary

Provided are an antigen-binding protein referred to as a "kappa/lambda" Fab-Fab series connection structure, preparation thereof, and use thereof, as well as a universal technical solution for preparing any two conventional IgG antibodies into a bispecific antigen-binding protein molecule having the structure.