3D Printed Small-Scale Mixer for Biopharmaceutical Stability

Solution Overview

Problem

Biopharmaceutical products, such as proteins, are unstable and prone to degradation due to mechanical agitation, high shear forces, adsorption, and aggregation during manufacturing, especially when mixed into aqueous formulations.

Innovation Solution

A system and method for producing a small-scale mixer using a 3D printer, where the mixer has dimensions scaled from an at-scale mixer but with independent second dimensions to minimize friction, particle generation, and shear forces, and a smoothing apparatus is used to smooth the surface of the mixer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a small-scale mixer is produced by directly scaling down dimensions from an at-scale mixer, then the mixer can be manufactured using 3D printing, but the surface roughness increases and mechanical stress on the mixer increases

Engineering Contradiction:

ImprovemanufacturabilityVSAvoidsurface roughness

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by independently determining second dimensions of the small-scale mixer that are not based on scaling from the at-scale mixer. This allows optimization of surface roughness and mechanical stress parameters while maintaining manufacturability through 3D printing capabilities.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent applies local quality by smoothing the surface of the small-scale mixer using a smoothing apparatus. This targeted surface treatment reduces surface roughness in specific areas without affecting the overall structure or manufacturing process.

Inventive Principle:

Principle #3Local quality

2Ease of manufacture

If a small-scale mixer is produced by directly scaling down dimensions from an at-scale mixer, then the mixer can be manufactured using 3D printing, but mechanical stress and shear forces on the mixer increase

Engineering Contradiction:

ImprovemanufacturabilityVSAvoidmechanical stress

Core Design Contradiction:

Ease of manufactureVSStress or pressure

Solution Approach 1:

The patent applies parameter changes by independently determining second dimensions of the small-scale mixer that are not based on scaling from the at-scale mixer. This allows optimization of surface roughness and mechanical stress parameters while maintaining manufacturability through 3D printing capabilities.

Inventive Principle:

Principle #35Parameter changes

3Ease of manufacture

If a small-scale mixer is produced by directly scaling down dimensions from an at-scale mixer, then the mixer can be manufactured using 3D printing, but particle generation increases

Engineering Contradiction:

ImprovemanufacturabilityVSAvoidparticle generation

Core Design Contradiction:

Ease of manufactureVSObject-generated harmful factors

Solution Approach 1:

The patent applies parameter changes by independently determining second dimensions of the small-scale mixer that are not based on scaling from the at-scale mixer. This allows optimization of surface roughness and mechanical stress parameters while maintaining manufacturability through 3D printing capabilities.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent applies local quality by smoothing the surface of the small-scale mixer using a smoothing apparatus. This targeted surface treatment reduces surface roughness in specific areas without affecting the overall structure or manufacturing process.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS20250162260A1Systems and methods for producing a mixer

Publication Date: 2025.05.22 REGENERON PHARMACEUTICALS INC

AI summary

Systems and method for producing a small-scale mixer are provided. In some implementations, a method for includes obtaining dimensions of an at-scale mixer. The method also includes determining first dimensions of the small-scale mixer based on respective dimensions of the at-scale mixer. The method further includes determining second dimensions of the small-scale mixer independent of the dimensions of the at-scale mixer. Additionally, the method includes generating the small-scale mixer using the first dimensions and the second dimensions using a three-dimensional printer.