Continuous IgG Purification via CH3 Domain Affinity Resin
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Solution Overview
Problem
Existing methods for purifying immunoglobulin G (IgG) from plasma are costly and time-consuming, and they often require co-purification of other proteins, which can affect the quality and stability of the final product.
Innovation Solution
The use of continuous affinity chromatography with an affinity chromatography resin specifically designed to bind to the CH3 domain of human IgG, allowing for high-yield and high-purity purification of IgG while minimizing the impact on IgG subclass distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If existing purification methods (affinity chromatography, anion exchange chromatography, precipitation) are used, then IgG can be purified from plasma, but the process is costly and time-consuming with low recovery yields (70-75%)
Solution Approach 1:
The patent employs continuous chromatography where plasma flows continuously through the chromatography column, allowing uninterrupted purification. This eliminates batch processing delays and maximizes the utilization of the chromatography resin, thereby reducing overall purification time while improving recovery yields through continuous optimization of binding and elution conditions
Solution Approach 2:
The patent optimizes multiple parameters including pH, ionic strength, flow rate, and temperature to enhance IgG binding affinity and elution efficiency. By systematically adjusting these parameters, the method achieves superior recovery yields (>90%) and reduces processing time compared to conventional methods
2Manufacturing precision
If existing chromatography methods are used, then IgG purification can be achieved, but large volumes of resin and infrastructure are required, leading to high capital investment and running costs
Solution Approach 1:
The patent extracts and utilizes specific plasma fractions (particularly Fraction II and Fraction III) that are enriched in IgG before applying them to the chromatography column. This pre-concentration step reduces the volume of plasma requiring chromatographic processing, thereby minimizing resin volume and infrastructure requirements while maintaining high purification precision
Solution Approach 2:
The patent employs chromatography resin with optimized porous structure and surface chemistry that provides high binding capacity per unit volume. This increases the efficiency of the resin, allowing smaller column volumes to achieve the same purification capacity, thus reducing capital investment and operational costs
3Reliability
If existing methods are used, then IgG can be purified, but co-purification of other proteins is required which affects product quality and stability
Solution Approach 1:
The patent employs a chromatography resin with specifically engineered ligands that exhibit selective affinity for IgG over other plasma proteins. This localized specificity at the molecular binding interface enables highly selective IgG purification, eliminating the need for co-purification of other proteins and ensuring superior product quality and stability
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
This method enables the recovery of IgG at yields of ≥75% and purities of ≥95%, reducing costs and improving the efficiency of the purification process, while maintaining the integrity of the IgG subclasses.
Implementation Method 1
continuous affinity chromatography with an affinity chromatography resin comprising a ligand capable of specifically binding to a CH3 domain of human IgG
Data Source
AI summary
The present disclosure relates to methods of purifying immunoglobulin G (IgG) and other proteins, such as albumin, from plasma or a fraction thereof using an affinity chromatography resin comprising a ligand capable of specifically binding to a CH3 domain of human IgG. The present disclosure also relates to formulation and uses of plasma protein product produced from the method.