Sulfonic Acid Copolymer Chromatographic Matrix for Antibody Purification
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current cation exchange membranes for flow-through purification of antibodies are limited by low cation exchange group density, temperature sensitivity, and pH range limitations, which restrict efficient purification of large amounts of physiologically active substances.
Innovation Solution
A cation exchange chromatographic matrix with a sulfonic acid group copolymer immobilized on a base material, having a graft rate of 5-200% and sulfonic acid group density between 30-200 mmol/L, and comprising no acrylamide or acrylamide derivatives, ensuring stability across a wide pH range and temperature variations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a cation exchange membrane with high cation exchange group density is used, then the purification efficiency and productivity are improved, but the temperature sensitivity and pH range limitations worsen
Solution Approach 1:
The patent uses a composite material consisting of a copolymer containing both a strong cation exchange group (sulfonic acid group) and a temperature-responsive group. This composite structure allows the material to maintain high cation exchange group density for improved purification efficiency while the temperature-responsive group modulates the physical properties to reduce temperature sensitivity. The copolymer combines functional groups with complementary characteristics to achieve both high productivity and reliability across varying temperatures and pH conditions.
2Productivity
If a cation exchange membrane with high cation exchange group density is used, then the purification efficiency is improved, but the complexity of maintaining stability across wide pH range and temperature variations increases
Solution Approach 1:
The patent employs parameter changes by incorporating a temperature-responsive group into the copolymer structure. This group undergoes conformational changes in response to temperature variations, which modulates the accessibility and activity of the cation exchange groups. Additionally, the strong cation exchange group (sulfonic acid group) maintains its ion exchange capability across a wide pH range, effectively changing the functional parameters of the material to adapt to different environmental conditions without requiring complex external control systems.
3Ease of manufacture
If acrylamide or acrylamide derivatives are included in the copolymer, then the manufacturing ease is improved, but the temperature-dependent fluctuations in purification effectiveness worsen
Solution Approach 1:
The patent extracts or removes acrylamide and acrylamide derivatives from the copolymer composition to eliminate the source of temperature-dependent fluctuations. Instead, the invention uses a copolymer comprising a strong cation exchange group and a temperature-responsive group that does not exhibit the same problematic temperature sensitivity. This extraction of the problematic component while retaining the essential copolymer structure achieves both ease of manufacture and purification 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
The solution enables efficient flow-through purification of antibodies with a recovery rate of 80% or more, reducing aggregates by 50% or more, and maintaining effectiveness without temperature or pH-dependent fluctuations.
Implementation Method 1
The ion exchange chromatography is a method which performs separation by reversibly adsorbing a counterion present in a mobile phase with an ion exchange group on adsorbent surface as a stationary phase
Implementation Method 2
a copolymer with one monomer unit having at least a sulfonic acid group, the copolymer being immobilized on the base material
Data Source
AI summary
A cation exchange chromatographic matrix comprising a base material, and a copolymer with one monomer unit having at least a sulfonic acid group, the copolymer being immobilized on the base material, wherein: the copolymer forms substantially no cross-linked structure, and the copolymer comprises neither acrylamide nor an acrylamide derivative as a monomer unit, or comprises acrylamide or an acrylamide derivative as a monomer unit in a range which has no substantial influence; the ratio of the mass of the copolymer to the mass of the base material is 5% or more and 200% or less; and the density of the sulfonic acid group is higher than 30 mmol/L and 200 mmol/L or lower.