Method and Device for Determining Mechanical Stress Load and Interface Effects on Particles Dispersed in a Fluid

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This patent describes a method and a device for determining the types and extent of mechanical stress—such as shear, rotational, and extensional stress—that act on particles, especially biomolecules like proteins, when they are dispersed in a fluid. The core invention is a device with movable, independently rotatable rolls inside a specifically designed chamber, allowing controlled application of various flow patterns to simulate different mechanical stresses. The system includes options for precise measurement of changes in the particles, enabling the assessment of stress-related degradation.

Use CasesContent extracted from patent full text and abstract with AI.

• Testing the stability of therapeutic proteins or antibodies under different fluid handling conditions in biotechnology or pharmaceutical manufacturing.
• Optimization of fluid formulations to enhance biomolecule stability during production, purification, or transport.
• Screening of biomolecules or formulations to select those most resistant to mechanical degradation for industrial applications.
• Design and validation of bioprocessing plants to ensure mechanical stress does not exceed tolerable levels for sensitive products.
• Analyzing the effect of different system interfaces (materials, surfaces) on particle stability or aggregation in process design.
• Development of more robust industrial proteins by understanding the structural factors affecting stress tolerance.

BenefitsContent extracted from patent full text and abstract with AI.

• Enables precise, reproducible measurement of mechanical stress effects on particles, overcoming limitations of traditional process equipment which lacks controlled flow conditions.
• Allows inline and online measurement of particle changes, providing real-time data for process optimization.
• Minimizes required sample volume and eliminates dead zones, saving materials and improving accuracy.
• Facilitates targeted stress simulations (shear, rotational, extensional), which helps in understanding specific degradation mechanisms of biomolecules.
• Improves product quality and yield by enabling optimization of process parameters to limit stress-induced degradation.
• Supports rational design of both protein formulations and production plants for better stability and performance.
• Allows separation of effects due to mechanical forces from surface/material interactions, supporting materials selection and process design.

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Patent Abstract

The present invention concerns a method and a device for determining mechanical stress load, and optionally interface effects, on particles dispersed in a fluid. According to the invention, fluid comprising dispersed particles such as bio molecules is fed into a sample space of a device comprising a jacket which encloses a sample chamber and at least two rolls arranged within said jacket such that said sample space is defined between said rolls, said rolls being independently rotatable with respect to each other, wherein said jacket has an inner surface which is essentially adapted to the outer surface of the rolls, rotational movement is imparted to at least one of the rolls of said device, and changes in the state of said particles are determined from which mechanical stress load acting on the particles can be determined.