Polymeric Resin Membrane for Antibody Purification
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Solution Overview
Problem
Current purification methods for therapeutic or diagnostic biological molecules, such as antibodies, are inefficient, costly, and time-consuming, particularly in removing trace impurities and achieving high purity and yield, necessitating the development of more scalable and cost-effective techniques.
Innovation Solution
A novel separation device comprising a porous support with a polymeric resin, where the resin includes structural units derived from vinyl cross-linkers and aromatic monomers with quaternary ammonium groups, capable of multi-modal interactions for efficient antibody purification, combining polishing and virus removal steps in a single unit operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional bead-based chromatographic techniques are used for antibody purification, then purification effectiveness is improved, but processing time and cost increase
Solution Approach 1:
The patent uses porous membrane supports with controlled pore sizes to enable high-flux separation. The porous structure provides large surface area for binding while maintaining high flow rates, resolving the contradiction between purification effectiveness and processing time by allowing rapid mass transfer through the membrane matrix.
Solution Approach 2:
The patent employs thin film membrane structures instead of traditional thick bead packs. The thin film design reduces diffusion path lengths and increases flow velocity through the separation medium, achieving both high purification effectiveness and reduced processing time simultaneously.
2Manufacturing precision
If multiple chromatographic techniques are combined for high purity and yield, then purification quality is improved, but device complexity and cost increase
Solution Approach 1:
The patent combines multiple chromatographic functions (affinity, ion-exchange, hydrophobic interaction) into a single membrane device by incorporating different ligand types on the same porous support. This integration achieves high purification quality while reducing device complexity by eliminating the need for multiple separate chromatography columns.
Solution Approach 2:
The membrane device is designed with multi-functional ligands that can perform multiple separation mechanisms simultaneously. The universal membrane structure can purify different antibody types using various interaction modes, reducing the need for multiple specialized devices and simplifying the overall purification system.
3Manufacturing precision
If separate polishing and virus removal steps are performed, then purification thoroughness is improved, but processing time and device complexity increase
Solution Approach 1:
The patent integrates the polishing function and virus removal function into a single membrane device. The membrane simultaneously captures trace impurities through chromatographic interactions and removes viruses through size exclusion and adsorption mechanisms, achieving thorough purification while reducing processing time by eliminating sequential steps.
4Manufacturing precision
If conventional membranes are used for trace impurity removal, then purification is improved, but capacity and efficiency decrease
Solution Approach 1:
The patent uses porous membrane materials with optimized pore size distributions that provide both high surface area for trace impurity capture and sufficient flow capacity. The porous structure enables simultaneous high purification precision and high productivity by allowing rapid mass transfer while maintaining large binding capacity.
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 device enables efficient separation of antibodies from unwanted compounds and viruses, improving purity and yield while reducing processing time and costs, by leveraging multi-modal interactions and integrating polishing and viral clearance steps within a single device.
Implementation Method 1
the polymeric resin is capable of selectivley retaining one or more compounds present in the biological solution through a multi-modal interaction
Implementation Method 2
A combination of various chromatographic techniques may be used to develop a multimodal chromatographic separation technique for purification of biological macromolecules
Data Source
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AI summary
The invention relates to a device for separating unwanted compounds from an antibody containing biological sample. The device comprises a porous support and a polymeric resin disposed within the pores of the porous support. The device may further comprise a viral clearance membrane upstream or downstream from the polymeric resin. Methods of use are also provided.