Polysaccharide Polymer Coating for Protein Stability

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Solution Overview

Problem

Protein aggregation and denaturing on polymer surfaces in medical devices and vessels lead to issues in diagnostics, drug delivery, and pharmaceutical stability, causing loss of potency and adverse immune responses, due to non-specific protein adsorption and complex interactions with container materials.

Innovation Solution

A method of coating polymer surfaces with a composition comprising polysaccharides, oligosaccharides, or polyols, which reduces protein adsorption and aggregation by treating the polymer surface with an oxidizing agent and incubating it with the composition, creating a hydrophilic surface that enhances thermal and intrinsic stability of pharmaceutical compositions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If polymer surfaces are used for storing pharmaceutical compositions, then the compositions can be stored in simple containers, but protein aggregation and denaturing occur leading to loss of potency

Engineering Contradiction:
Improvecontainer simplicityVSAvoidprotein stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The invention applies a coating layer comprising polysaccharides, oligosaccharides, polyols or mixtures thereof onto polymer surfaces to create a composite material system. This coating modifies the surface properties of the polymer to prevent protein aggregation and denaturing while maintaining the bulk polymer's simplicity and manufacturing advantages. The coating acts as an intermediary between the protein and the polymer surface, eliminating harmful interactions.

Inventive Principle:
Principle #40Composite materials

2Reliability

If surface modifications are applied to mitigate protein adsorption, then protein stability improves, but the manufacturing process becomes more complex

Engineering Contradiction:
Improveprotein stabilityVSAvoidsurface modification process
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention changes the surface parameters of the polymer by coating it with specific substances (polysaccharides, oligosaccharides, polyols) that have favorable properties for protein stability. This approach modifies the surface chemistry and physics parameters to reduce protein adsorption and aggregation, while the coating process itself can be integrated into existing manufacturing workflows, limiting the increase in complexity.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If inorganic coatings like SiOx are applied to reduce protein adsorption, then protein stability improves, but the coating process becomes more complex and may cause leaching

Engineering Contradiction:
Improveprotein stabilityVSAvoidcoating process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention employs organic coating materials (polysaccharides, oligosaccharides, polyols) that can be applied as disposable or single-use coatings on polymer surfaces. These materials provide effective protein stability protection without the leaching issues associated with inorganic coatings. The coating process can be simplified compared to inorganic coating methods, and the materials are compatible with standard manufacturing processes.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 coated polymer surfaces significantly reduce protein and oligonucleotide adsorption and aggregation, improving the stability and storage conditions of pharmaceutical compositions, allowing for longer storage at higher temperatures and reducing the risk of adverse immune responses.

Implementation Method 1

treating at least a portion of the polymer surface with an oxidising agent

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 2

treating at least a portion of the polymer surface with a composition comprising a polysaccharide, oligosaccharide, polyol or mixture thereof

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS20240084157A1Methods of coating polymers and reduction in protein aggregation
Publication Date: 2024.03.14 GLYCOME BIOPHARMA LTD
  • US20240084157A1 patent drawing
  • US20240084157A1 patent drawing
  • US20240084157A1 patent drawing

AI summary

A method of coating a polymer surface, the method comprising: providing a polymer having a surface, optionally, treating at least a portion of the polymer surface with an oxidising agent, treating at least a portion of the polymer surface with a composition comprising a polysaccharide, oligosaccharide, polyol or mixture thereof, and incubating the treated polymer with the composition for a predetermined time. Also disclosed are polymers comprising such a coating, vessels comprising such coated polymers and medicals devices comprising such polymers.