Chemically Defined Vaccine Stabilizer for Freeze-Drying
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Solution Overview
Problem
Current stabilizer compositions in the bio-pharmaceutical industry, particularly for freeze-drying, often rely on ill-defined, high molecular weight compounds from animal or microbial origins, which can introduce contamination risks, are not heat sterilizable, and exhibit lot-to-lot variation, leading to unpredictable product quality and safety concerns.
Innovation Solution
A stabilizer composition comprising chemically defined amino acids and sugars, which are serum-free, protein-free, and animal compound-free, providing predictable and controllable stabilization of biological molecules and microorganisms without the need for high molecular weight compounds, and are non-toxic and heat sterilizable.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stabilizer compositions use high molecular weight compounds from animal or microbial origins, then stabilizing effect is improved, but contamination risk and safety concerns increase
Solution Approach 1:
The invention extracts and eliminates the harmful components (animal proteins, microbial contaminants) from the stabilizer composition while retaining the essential stabilizing function through chemically defined amino acids and sugars. This extraction principle resolves the contradiction by removing the source of contamination risk while preserving the stabilizing effect.
Solution Approach 2:
The invention changes the chemical definition and molecular weight parameters of the stabilizer components. Instead of using ill-defined high molecular weight compounds, it employs chemically defined amino acids and sugars with specific molecular weights, thereby maintaining stabilizing efficacy while eliminating contamination risks associated with undefined compositions.
2Reliability
If stabilizer compositions use compounds from animal origin, then stabilizing effect is improved, but heat sterilization capability deteriorates
Solution Approach 1:
The invention uses simple, stable chemical compounds (amino acids and sugars) that can be readily sterilized by heat, replacing complex animal-derived stabilizers that cannot withstand heat sterilization. These chemically defined components are robust enough to endure sterilization processes while maintaining their stabilizing function.
3Reliability
If stabilizer compositions use compounds from animal or microbial origins, then stabilizing effect is improved, but product quality consistency deteriorates due to lot-to-lot variation
Solution Approach 1:
The invention changes the compositional parameters from ill-defined natural products to chemically defined amino acids and sugars with precise molecular structures. This parameter change eliminates lot-to-lot variation inherent in animal and microbial-derived compounds, ensuring consistent product quality while maintaining stabilizing efficacy.
Solution Approach 2:
The invention employs chemically homogeneous amino acids and sugars with defined structures, replacing heterogeneous animal and microbial compounds. This homogeneity ensures consistent stabilizing performance across different production batches, resolving the quality consistency issue.
4Reliability
If stabilizer compositions use high molecular weight compounds, then stabilizing effect is improved, but complexity of composition increases
Solution Approach 1:
The invention segments the complex high molecular weight stabilizer compounds into simpler building blocks - chemically defined amino acids and sugars. These smaller, well-defined molecular units collectively provide the stabilizing effect without the complexity and undefined composition of high molecular weight compounds.
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 composition effectively stabilizes biological molecules and microorganisms against physical and chemical influences, maintaining quality and quantity during freeze-drying, storage, and reconstitution, while ensuring product safety and consistency.
Implementation Method 1
a stabiliser composition comprising an amino acid, and a sugar wherein all compounds are chemically defined
Implementation Method 2
In freeze-drying a sample containing a biologically or pharmaceutically active molecule, a micro-organism, a cell, or a tissue is first frozen, and than dried under vacuum
Implementation Method 3
a sample containing a biologically or pharmaceutically active molecule, a micro-organism, a cell, or a tissue is first frozen, and than dried under vacuum
Data Source
AI summary
The present invention relates to a stabilizer composition comprising an amino acid, and a sugar wherein all compounds are chemically defined; to a vaccine composition comprising such a stabilizer composition and a biological molecule and/or a micro-organism; to a method for preparing a pharmaceutical composition comprising admixing such a stabilizer composition with a biological molecule and/or a micro-organism; to the use of such a stabilizer composition, and of vaccines prepared therewith.