Automated Nucleic Acid Amplification and Purification at Point of Need

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Solution Overview

Problem

Current nucleic acid production workflows for medical therapeutics are labor-intensive, generate significant chemical waste, and require centralized facilities, making them inefficient and unsuitable for rapid deployment at points of need, while also necessitating protein removal to meet high-quality standards.

Innovation Solution

A system and method for automated nucleic acid synthesis and purification that includes real-time monitoring and a functionally closed process, utilizing modules for amplification and purification, with sensors and controllers to ensure quality and quantity, and rehydration of lyophilized reagents for efficient production.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If manual labor intensive steps are used in current workflows, then flexibility and adaptability are improved, but productivity and time efficiency deteriorate

Engineering Contradiction:

Improveworkflow flexibilityVSAvoidproduction speed

Core Design Contradiction:

Adaptability or versatilityVSProductivity

Solution Approach 1:

The system performs self-monitoring and self-regulation through automated sensors that detect reaction parameters (pH, temperature, pressure, optical density) and automatically adjust conditions without human intervention, enabling both high productivity and adaptability through intelligent automation

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

Manual mechanical operations are replaced with automated electronic control systems, sensors, and computerized monitoring that can rapidly respond to process changes, simultaneously improving production speed while maintaining workflow flexibility through programmable control

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Manufacturing precision

If centralized GMP facilities are used, then manufacturing precision and quality control are improved, but loss of time and deployment speed deteriorate

Engineering Contradiction:

Improvequality controlVSAvoiddeployment time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The centralized manufacturing process is segmented into modular automated units that can be deployed distributively at point-of-need locations, with each module containing essential functions (amplification, purification, formulation) to maintain quality control independently while reducing deployment time

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system maintains GMP-quality manufacturing precision by implementing real-time automated monitoring of critical parameters (temperature, pH, pressure, optical density) and adjusting conditions dynamically, enabling high-quality production in distributed locations without requiring centralized facilities

Inventive Principle:

Principle #35Parameter changes

3Manufacturing precision

If functionally closed system is implemented, then purity and contamination control are improved, but device complexity increases

Engineering Contradiction:

ImprovepurityVSAvoidsystem complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

Multiple functions (amplification, purification, formulation, monitoring) are merged into an integrated automated system with unified control, reducing operational complexity while maintaining closed-system purity through coordinated execution of combined processes

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

Automated robotic arms and transfer mechanisms serve as intermediaries that physically connect different modules while maintaining sterile barriers and closed-system integrity, enabling complex multi-step processes without direct human contact that would compromise purity

Inventive Principle:

Principle #24Intermediary (Mediator)

4Measurement precision

If real-time inline monitoring is performed, then measurement precision and quality control are improved, but use of energy and device complexity increase

Engineering Contradiction:

Improvequality monitoringVSAvoidenergy consumption

Core Design Contradiction:

Measurement precisionVSUse of energy by moving object

Solution Approach 1:

Monitoring is performed continuously throughout the reaction process rather than through discrete sampling, allowing early detection of deviations and optimized energy usage by maintaining stable conditions through real-time feedback control

Inventive Principle:

Principle #20Continuity of useful action

Solution Approach 2:

Sensors provide real-time feedback on reaction parameters (pH, temperature, pressure, optical density) that is automatically processed to adjust process conditions, improving measurement precision while optimizing energy consumption through intelligent control algorithms

Inventive Principle:

Principle #23Feedback

Data Source

PatentUS20260062728A1Systems and methods to improve nucleic acid synthesis and production

Publication Date: 2026.03.05 GE PRECISION HEALTHCARE LLC

AI summary

A system includes a nucleic acid amplification module configured to receive deoxyribonucleic acid (DNA) template and to generate a nucleic acid product from the DNA template utilizing an amplification reaction while performing real-time inline monitoring of the amplification reaction via a plurality of sensors. The system also includes a purification module configured to purify the nucleic acid product. The nucleic acid amplification module and the purification module are each automated and form a functionally closed system.