Affinity Chromatography Media for pH-Stable Anti-A/B Removal
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Solution Overview
Problem
Existing chromatography media for removing anti-A and anti-B antibodies are limited by their stability under varying pH conditions, leading to reduced binding capacity and effectiveness after exposure to acid or alkaline solutions, which complicates large-scale operations and increases the risk of impurity breakthrough.
Innovation Solution
Development of chromatography media with stable solid supports and antigen ligands that maintain their ability to remove anti-A and anti-B antibodies under both acid and alkaline conditions, using a sanitization method with phosphoric acid, acetic acid, and benzyl alcohol, and allowing for cleaning-in-place without loss of performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing chromatography media are used to remove anti-A and anti-B antibodies, then antibody removal function is provided, but binding capacity is reduced after exposure to acid or alkaline solutions
Solution Approach 1:
The patent modifies the chemical parameters of the chromatography media by incorporating acid-stable and base-stable ligands that maintain their binding properties across a wide pH range (pH 2-12). This allows the media to withstand acid and base cleaning treatments without degradation of binding capacity, directly resolving the contradiction between reliability and stability under pH conditions.
Solution Approach 2:
The patent employs composite chromatography media combining stable support materials with specifically designed acid-stable and base-stable ligands. This composite structure provides both the mechanical stability needed for cleaning-in-place procedures and the chemical stability to maintain binding capacity under extreme pH conditions, simultaneously improving reliability and pH stability.
2Ease of manufacture
If chromatography media are cleaned with acid or base solutions, then sanitization is achieved, but binding capacity is lost
Solution Approach 1:
The patent enables the chromatography media to function as reusable components by making them resistant to degradation from acid and base cleaning. Instead of requiring replacement after limited use, the media can undergo multiple cleaning-in-place cycles, effectively transitioning from a short-lived to a long-lived component while maintaining binding capacity.
Solution Approach 2:
The patent changes the chemical resistance parameters of the chromatography media through the use of stable ligands and support materials. This modification allows the media to withstand the harsh chemical environment of acid and base sanitization procedures without losing binding capacity, enabling effective cleaning while preserving functionality.
3Reliability
If natural source immunoadsorbents are used, then antibody removal is achieved, but batch consistency is poor
Solution Approach 1:
The patent replaces natural source immunoadsorbents with synthetically copied versions that replicate the desired binding properties. The synthetic ligands are designed to mimic the antigen-antibody interactions of natural systems while providing uniform, reproducible structures that ensure consistent performance across batches, resolving the contradiction between effectiveness and manufacturing precision.
Solution Approach 2:
The patent changes the source and structure of the immunoadsorbent material from natural to synthetic origins. This fundamental parameter change enables precise control over the chemical and physical properties of the media, ensuring batch-to-batch consistency while maintaining or improving antibody removal effectiveness through optimized synthetic designs.
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 media maintains high binding capacity and effectiveness even after prolonged exposure to extreme pH conditions, providing flexibility in operating conditions and reducing impurity breakthrough, making it suitable for large-scale applications.
Implementation Method 1
Affinity chromatography media for removal of anti-A and/or anti-B antibodies
Implementation Method 2
The blood group antigen ligands in the Glycosorb-ABO device bind and remove the blood group A antigen antibodies (anti-A) and blood group B antigen antibodies (anti-B) from the blood of organ donors
Data Source
AI summary
Embodiments described herein relate to novel chromatography media for removing anti-A and/or anti-B antibodies from a sample, as well as methods of using the same. The media described herein have several advantages over previously described media including, acid and alkaline stability.