Biomolecule Drying via Staged Temperature and Pressure Control

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Solution Overview

Problem

Biomolecules used in biological reactions, such as PCR or enzymatic catalysis, are prone to degradation when stored in solution form, and existing drying methods for long-term storage can be inefficient or cause undesired degradation due to the impact of non-volatile components and temperature exposure.

Innovation Solution

A method involving dispensing a composition of biomolecules, polysaccharides, and a liquid volatile component on a surface, followed by controlled evaporation between an initial and final temperature, with the initial temperature minimizing biomolecule degradation and the final temperature achieving a glassy state with reduced residual solvent, thereby stabilizing the biomolecule.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the solution is dried for a long time under low pressure to reach dryness state, then long-term stability is achieved, but the process is difficult to apply to large-scale production

Engineering Contradiction:
Improvelong-term stabilityVSAvoidlarge-scale production
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The invention changes the pressure parameter during drying, transitioning from low pressure (200 mBar) to atmospheric pressure to enable large-scale production while maintaining stability. This parameter change allows the process to be scalable without sacrificing the dryness state required for long-term stability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention dynamically adjusts drying conditions by first drying under low pressure to achieve initial dryness, then transitioning to atmospheric pressure for final drying. This dynamic approach allows optimization for both stability and productivity at different stages of the drying process.

Inventive Principle:
Principle #15Dynamics

2Productivity

If high temperature is used to dry the solution quickly, then drying time is reduced, but the biomolecule may lose activity due to denaturation or degradation

Engineering Contradiction:
Improvedrying speedVSAvoidbiomolecule activity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The invention segments the drying process into two distinct temperature stages: an initial stage at lower temperature (30-50°C) to preserve biomolecule activity, and a final stage at higher temperature (60-90°C) to achieve complete dryness. This segmentation allows each stage to optimize for its specific goal without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention performs preliminary drying at lower temperature before applying higher temperature. This preliminary action removes the bulk of solvent under gentle conditions, preserving biomolecule activity, and prepares the sample for the final high-temperature drying step that achieves complete dryness without prolonged exposure to damaging heat.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If non-volatile components are present in the solution, then the initial solution can be formulated, but their concentration increases during drying and has a destabilizing effect on the biomolecule

Engineering Contradiction:
Improvesolution formulationVSAvoidbiomolecule stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The invention dynamically controls the drying process by adjusting pressure and temperature in stages, which manages the concentration trajectory of non-volatile components. By transitioning from low to atmospheric pressure and using staged heating, the process controls the rate at which non-volatile components concentrate, preventing destabilizing effects while achieving complete dryness.

Inventive Principle:
Principle #15Dynamics

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

This method effectively reduces biomolecule degradation and maintains activity, allowing for stable long-term storage by minimizing mobility and exposure to high temperatures, making it suitable for large-scale production.

Implementation Method 1

at least a polysaccharide being designed for forming together with the at least a biomolecule and a part of the at least a liquid volatile component a matrix displaying a glass transition temperature Tg

Methodology Applied
Scientific EffectGlass transition:

Implementation Method 2

Evaporating at least a part of the at least a liquid volatile component by adjusting the temperature of said composition to allow the formation of the matrix

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentEP3008177B1Biomolecule drying process for long-term storage
Publication Date: 2020.06.03 BIOCARTIS NV

AI summary

The present invention relates to a method for producing a storable dry composition of biomolecule. First a composition is dispensed on a surface. The composition comprises at least a biomolecule, at least a liquid volatile component, at least a polysaccharide being designed for forming together with the at least a biomolecule and a part of the at least a liquid volatile component a matrix displaying a glass transition temperature Tg. Secondly, at least a part of the liquid volatile component is evaporated by adjusting the temperature of said composition to allow the formation of the matrix. Said evaporation step is initiated at an initial temperature T1, and finished up at a final temperature T2, said final temperature T2 being above said initial temperature T1.