Low-Shear Peptide Emulsion Manufacturing for Stable Delivery
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Solution Overview
Problem
Existing methods for manufacturing peptide emulsions on an industrial scale face challenges such as peptide aggregation, degradation, and variability in peptide concentration due to high shear and high speed emulsification, which compromise the stability and immunogenicity of peptide vaccines.
Innovation Solution
A method involving low shear mixing conditions at 100 to 1000 rpm for 2 to 15 minutes is used to prepare peptide emulsions, avoiding oxidative stress and aggregation, ensuring reproducibility and stability of the emulsion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high shear and high speed emulsification is used, then emulsification efficiency is improved, but peptide aggregation and degradation occur
Solution Approach 1:
The patent inverts the conventional emulsification approach by using low shear conditions (100-1000 rpm) instead of high shear conditions. This reversal of the traditional high-speed emulsification method prevents peptide aggregation and degradation while still achieving stable emulsion formation, directly resolving the contradiction between emulsification efficiency and peptide stability
Solution Approach 2:
The patent changes the key parameter of shear stress from high to low during emulsification. By controlling the rotation speed at 100-1000 rpm and maintaining low shear conditions, the process achieves both adequate emulsification and peptide stability, transforming the harmful high-shear process into a beneficial low-shear process
2Speed
If high speed mixing is used, then emulsion formation is accelerated, but peptide oxidation and degradation increase
Solution Approach 1:
The patent inverts the conventional high-speed mixing approach by deliberately using low-speed mixing (100-1000 rpm). This inversion reduces oxidative stress and mechanical degradation on peptides while still achieving effective emulsion formation through extended mixing time and low shear conditions
3Adaptability or versatility
If soluble and insoluble peptides are mixed together, then vaccine composition is improved, but aggregation risk increases
Solution Approach 1:
The patent changes the mixing parameters to low shear conditions (100-1000 rpm) that are gentle enough to handle both soluble and insoluble peptides without causing aggregation. This parameter adjustment allows the formulation to maintain versatility in peptide combination while ensuring stability of the final emulsion composition
Solution Approach 2:
The patent uses an adjuvant as an intermediary substance that facilitates the mixing of soluble and insoluble peptides. The adjuvant acts as a mediator that helps disperse both types of peptides uniformly in the emulsion without direct high-shear contact between them, reducing aggregation risk while maintaining formulation versatility
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 produces a stable, reproducible peptide emulsion that maintains peptide integrity and immunogenicity, suitable for large-scale production and compliance with pharmaceutical regulations.
Implementation Method 1
emulsifying a suspension of at least two peptides under low shear conditions, at a rotation speed of between 100 and 1000 rpm, during 2 to 15 minutes, with at least one adjuvant
Implementation Method 2
emulsifying a suspension of at least two peptides under low shear conditions
Data Source
AI summary
The present invention pertains to a method for manufacturing a ready-to-use peptide emulsion on the industrial scale, comprising the step of emulsifying a suspension of at least two peptides under low shear conditions with at least one adjuvant. It is also directed to a ready-to-use emulsion obtainable according to this method. This invention allows the delivery of a scalable emulsion of peptides which preserves their integrity and fulfills the requirements needed for a pharmaceutical sterile product.