MIS Storage Buffer Composition for Proteolysis Control

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Solution Overview

Problem

Purified Müllerian Inhibiting Substance (MIS) is prone to cleavage and degradation by proteolytic enzymes, leading to decreased shelf-life and loss of bioactivity.

Innovation Solution

A storage buffer composition comprising deionized water, buffering agent (e.g., HEPES), salt (NaCl), sugar alcohol (mannitol), gelatin, surfactant (Tween-20), and biocide (Micr-O-protect) stabilizes MIS by preventing proteolysis, maintaining bioactivity at 2°C to 8°C.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If purified MIS is stored without stabilization measures, then the storage buffer is simple, but the shelf-life is short and bioactivity is lost due to proteolytic degradation

Engineering Contradiction:
Improveshelf-life of purified MISVSAvoidcomplexity of storage buffer composition
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The storage buffer employs a composite formulation containing multiple stabilizing components including sugar alcohols (mannitol, sorbitol), gelatin, surfactants (Tween-20), and biocides (Micr-O-protect). This composite approach addresses proteolytic degradation through synergistic action of different ingredients, extending MIS shelf-life while maintaining bioactivity without requiring overly complex processing or storage conditions

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

Gelatin acts as an intermediary protective agent in the storage buffer, forming a protective matrix around the MIS protein that physically shields it from proteolytic enzymes. This mediator approach allows the MIS to remain stable in storage without requiring complete elimination of proteases, thereby extending shelf-life while keeping the buffer composition manageable

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If conventional storage buffers are used, then the buffer composition is simple, but proteolytic degradation occurs leading to loss of bioactivity

Engineering Contradiction:
Improvebioactivity stability of MISVSAvoidstorage buffer composition
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The storage buffer converts the potentially harmful presence of proteolytic enzymes into a beneficial situation by adding biocides (Micr-O-protect) that specifically target and neutralize these enzymes. Additionally, the surfactant Tween-20 is used to disrupt enzyme-protein interactions, transforming the degradation threat into a stable storage condition while maintaining a relatively simple buffer formulation

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The storage buffer optimizes physical-chemical parameters including pH (maintained by buffering agents), ionic strength (adjusted with salts like NaCl), and osmolarity (controlled by sugar alcohols like mannitol). These parameter optimizations create an environment that inherently stabilizes MIS protein structure and reduces susceptibility to proteolytic degradation, enhancing reliability without excessive complexity

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If MIS is stored at extended time periods, then long-term storage is achieved, but concentration loss increases beyond acceptable levels

Engineering Contradiction:
Improvestorage duration of MISVSAvoidconcentration loss of MIS
Core Design Contradiction:
Duration of action of stationary objectVSLoss of substance

Solution Approach 1:

The storage buffer performs preliminary protective actions by pre-incorporating stabilizing agents that prevent degradation before it occurs. Sugar alcohols like mannitol and sorbitol are included to maintain proper hydration and prevent protein aggregation, while gelatin provides a protective matrix. This preliminary stabilization allows MIS to be stored for extended periods with concentration loss limited to 10% or less over 60 days

Inventive Principle:
Principle #10Preliminary action

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 buffer extends MIS shelf-life and maintains bioactivity, with concentration loss reduced to 10% or less over 60 days, suitable for diagnostic use.

Implementation Method 1

The at least one sugar alcohol is mannitol... stabilizes MIS by preventing proteolysis

Methodology Applied
Scientific EffectMolecular crowding:

Implementation Method 2

The at least one sugar alcohol is mannitol... stabilizes MIS by preventing proteolysis

Methodology Applied
Scientific EffectPreferential exclusion:

Implementation Method 3

gelatin... stabilizes MIS by preventing proteolysis

Methodology Applied
Scientific EffectMatrix formation:

Implementation Method 4

surfactant (Tween-20)... stabilizes MIS by preventing proteolysis

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Implementation Method 5

buffering agent (e.g., HEPES)... stabilizes MIS by preventing proteolysis

Methodology Applied
Scientific EffectBuffering:

Implementation Method 6

biocide (Micr-O-protect) stabilizes MIS by preventing proteolysis

Methodology Applied
Scientific EffectEnzyme inhibition: Enzyme

Data Source

PatentEP3856230B1Storage solution compositions for the stabilization of purified mÜllerian inhibiting substance (MIS) and methods of use and production related thereto
Publication Date: 2025.09.03 SIEMENS HEALTHCARE DIAGNOSTICS INC
  • EP3856230B1 patent drawingFigure 1A~1B
  • EP3856230B1 patent drawingFigure 1C~1D
  • EP3856230B1 patent drawingFigure 1E

AI summary

Non-limiting embodiments of an improved Müllerian Inhibiting Substance storage buffer composition(s) and method(s) of stabilizing a Müllerian Inhibiting Substance in the improved storage buffer composition.