Systems and methods for analyzing antibody co-formulations
A bead-based system with donor and acceptor beads and chemiluminescent dyes addresses the challenges of quantifying co-formulated biological molecules, offering precise detection and scalable analysis for multiple antigen-binding proteins.
Patent Information
- Application Number
- JP2025543245
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-01-30
- Filing Date
- 2024-01-29
- Publication Date
- 2026-02-18
AI Technical Summary
There is a need for accurate systems and methods to determine the concentration of co-formulated biological molecules in pharmaceutical preparations, addressing analytical challenges, manufacturing issues, and stability concerns such as protein-protein interactions and protein aggregation in combination biologics.
A bead-based system using donor and acceptor beads with specific binding pairs and chemiluminescent dyes to detect and quantify multiple antigen-binding proteins, employing a homogeneous multiplex assay that generates amplified chemiluminescent signals upon photoexcitation.
Enables precise detection and quantification of multiple antigen-binding proteins in a single sample without washing, overcoming challenges of protein-protein interactions and aggregation, and providing scalable and adaptable analysis for various co-formulations.