Interactive RNA Production Simulation for Continuous Process Development

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Solution Overview

Problem

Biopharmaceutical manufacturing processes are time-consuming, resource-intensive, and expensive due to reliance on batch production methods, necessitating a shift towards continuous manufacturing systems.

Innovation Solution

Development of interactive simulators that utilize historical data and literature to create simulated models for continuous RNA production, allowing for safe, controlled, and iterative exploration of various scenarios, reducing the need for real-world experimentation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If batch production methods are used, then product quality can be maintained through manual control, but manufacturing time and costs increase significantly

Engineering Contradiction:
Improveproduct qualityVSAvoidmanufacturing time
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent creates a digital twin (virtual model) of the continuous manufacturing process that replicates real-world behavior. This virtual copy allows for process development, testing, and optimization without physical experimentation, significantly reducing manufacturing time while maintaining product quality through accurate simulation of batch production characteristics

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The system performs preliminary process development and validation in the virtual environment before actual manufacturing. By conducting all process parameter optimization, risk assessment, and protocol development in the digital twin beforehand, the real manufacturing process can proceed efficiently with pre-validated parameters, reducing overall manufacturing time while ensuring quality

Inventive Principle:
Principle #10Preliminary action

2Reliability

If real-world experimentation is conducted for process development, then accurate process understanding is achieved, but costs and time consumption increase

Engineering Contradiction:
Improveprocess understanding accuracyVSAvoidprocess development time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent creates a digital twin (virtual model) of the continuous manufacturing process that replicates real-world behavior. This virtual copy allows for process development, testing, and optimization without physical experimentation, significantly reducing manufacturing time while maintaining product quality through accurate simulation of batch production characteristics

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The system performs preliminary process development and validation in the virtual environment before actual manufacturing. By conducting all process parameter optimization, risk assessment, and protocol development in the digital twin beforehand, the real manufacturing process can proceed efficiently with pre-validated parameters, reducing overall manufacturing time while ensuring quality

Inventive Principle:
Principle #10Preliminary action

3Productivity

If continuous manufacturing is implemented, then productivity and cost efficiency improve, but process complexity and validation requirements increase

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidprocess validation complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system performs preliminary process development and validation in the virtual environment before actual manufacturing. By conducting all process parameter optimization, risk assessment, and protocol development in the digital twin beforehand, the real manufacturing process can proceed efficiently with pre-validated parameters, reducing overall manufacturing time while ensuring quality

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The virtual model incorporates feedback mechanisms that continuously compare simulated outcomes with target specifications. This feedback loop enables automatic identification of process deviations and optimization opportunities, simplifying validation by providing clear evidence of process control and performance

Inventive Principle:
Principle #23Feedback

4Manufacturing precision

If extensive experimentation is performed to optimize process parameters, then product yield and quality improve, but resource consumption and costs increase

Engineering Contradiction:
Improveproduct yieldVSAvoidresource consumption
Core Design Contradiction:
Manufacturing precisionVSLoss of substance

Solution Approach 1:

The patent creates a digital twin (virtual model) of the continuous manufacturing process that replicates real-world behavior. This virtual copy allows for process development, testing, and optimization without physical experimentation, significantly reducing manufacturing time while maintaining product quality through accurate simulation of batch production characteristics

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The system performs preliminary process development and validation in the virtual environment before actual manufacturing. By conducting all process parameter optimization, risk assessment, and protocol development in the digital twin beforehand, the real manufacturing process can proceed efficiently with pre-validated parameters, reducing overall manufacturing time while ensuring quality

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20250378906A1Methods and arrangements for interactive simulation of xrna production
Publication Date: 2025.12.11 ARRANTA BIO HOLDINGS LLC
  • US20250378906A1 patent drawing
  • US20250378906A1 patent drawing
  • US20250378906A1 patent drawing

AI summary

Logic may interact, via one or more interface models, with a client to obtain client input to determine client data for a sequence for a type of ribonucleic acid (RNA). Logic may analyze, via one or more intuitive models, the client data based on historical batch data and experimental batch data to identify additional client data to achieve one or more target metrics of the client data. And logic may simulate, by one or more process models, continuous RNA production based on the client data and the additional client data to generate one or more experimental outcomes of the continuous RNA production defined by the client data and to output a development plan for the continuous RNA production. And logic may amend the client data and the additional client data after each iteration of simulation and perform additional iterations of the simulation until one or more target metrics are met.