Dry Stabilizing Composition for Biological Materials

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Solution Overview

Problem

Current methods for preserving biological materials, such as proteins and bacteria, during long-term storage at high temperatures and varying humidity levels are inadequate, as they often result in denaturation of proteins and cell rupture, and are not suitable for sensitive bioactives like live or attenuated bacteria and viruses.

Innovation Solution

A dry stabilizing composition comprising a mixture of carbohydrates (10-80% oligosaccharides, 5-30% disaccharides, and 1-10% polysaccharides) and hydrolyzed proteins (0.5-40%) is combined with bioactive materials, then snap-frozen and dried under vacuum to form a glassy, amorphous structure, maintaining the bioactive material's activity and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If traditional freeze-drying is used to preserve biological materials, then long-term storage stability is improved, but protein denaturation and cell rupture occur due to freezing stress

Engineering Contradiction:

Improvestorage stabilityVSAvoidprotein denaturation and cell rupture

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The invention changes the physical state parameter by using a liquid drying process instead of freezing, maintaining the material in a liquid or semi-liquid state throughout the drying process to avoid ice crystal formation and associated mechanical damage to cells and proteins

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention replaces the mechanical freezing process with a chemical/physical liquid drying process using hydrophobic materials that create a protective barrier, substituting the harmful mechanical stress of ice crystal formation with a gentle liquid phase drying mechanism

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Adaptability or versatility

If high temperatures and humidity are used for storage, then shipping and storage conditions are improved, but biological material activity is reduced due to degradation

Engineering Contradiction:

Improveshipping and storage conditionsVSAvoidbiological material activity

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The invention introduces hydrophobic materials as intermediary protective agents that form a barrier between the biological material and the harsh storage environment, allowing the material to withstand high temperatures and humidity while maintaining activity through rehydration

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention creates a composite structure combining the biological material with hydrophobic protective materials, forming a stable composite that can endure harsh storage conditions while preserving the biological activity of the embedded material

Inventive Principle:

Principle #40Composite materials

3Stability of the object's composition

If tableting processes are used to formulate biological materials, then product stability is improved, but excessive loss of activity occurs due to high pressure and temperature

Engineering Contradiction:

Improveproduct stabilityVSAvoidbiological material activity

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The invention applies hydrophobic protective materials beforehand to coat or embed the biological material, creating a protective cushion that shields the sensitive bioactives from the high pressure and temperature stresses of the tableting process

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 method provides superior stability and preservation of biological materials, retaining significant activity upon rehydration and maintaining viability under harsh storage conditions, including elevated temperatures and humidity, without excessive loss during tableting.

Implementation Method 1

snap-freezing the slurry in liquid nitrogen to form solid frozen particles, beads, droplets or strings

Methodology Applied

Scientific EffectFreezing: Freezing

Implementation Method 2

primary drying by water removal under vacuum of the product of step (b) while maintaining it at a temperature above its freezing temperature

Methodology Applied

Scientific EffectEvaporation: Evaporation

Implementation Method 3

secondary drying of the product of step (c) at maximum vacuum and a temperature of 20° C. or higher for a time sufficient to reduce the water activity to below 0.3 Aw

Methodology Applied

Scientific EffectDesorption: Desorption

Data Source

PatentUS10575545B2Stabilizing composition for biological materials

Publication Date: 2020.03.03 ADVANCED BIONUTRITION CORP

AI summary

Dry stabilizing compositions for bioactive materials include sugars and hydrolyzed proteins, and may be formed into tablets or other forms providing enhanced stability for the bioactive material. Compositions containing the bioactive materials may be produced by a method that includes (a) combining the bioactive material with other ingredients in an aqueous solvent to form a viscous slurry; (b) snap-freezing the slurry in liquid nitrogen to form solid frozen particles, beads, droplets or strings; (c) primary drying by water removal under vacuum of the product of step (b) while maintaining it at a temperature above its freezing temperature; and (d) secondary drying of the product of step (c) at maximum vacuum and a temperature of 20° C. or higher for a time sufficient to reduce the water activity to below 0.3 Aw.