Standardized Bioprocess Element Structure for Reproducible Design
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Solution Overview
Problem
Biological synthetic processes face challenges in standardization and reproducibility due to numerous variables influencing yield, leading to suboptimal design decisions and institutional resistance to change, especially across different manufacturing facilities.
Innovation Solution
The implementation of a method and system using standardized element structures for biological processes, comprising functional section blocks such as imports, parameters, data, physical inputs, requirements, setup, and execution steps, allowing for reproducible and scalable workflows through a computer-implemented approach with a server, database, and laboratory information management system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional trial and error development is used for bioprocess design, then design flexibility is maintained, but productivity and reliability are reduced due to suboptimal decisions and substantial resource requirements
Solution Approach 1:
The patent segments the bioprocess design into discrete, standardized unit operations that can be independently selected and optimized. Each unit operation represents a modular building block with defined inputs, outputs, and parameters, allowing systematic assembly of complete processes without requiring trial-and-error redesign of entire systems.
Solution Approach 2:
The patent enables systematic variation of process parameters through standardized unit operations with configurable parameters. This allows efficient exploration of design space by changing individual parameters within standardized frameworks, rather than conducting resource-intensive trial-and-error experiments across entire processes.
2Reliability
If standardized approaches are implemented for bioprocess design, then reliability and reproducibility improve, but device complexity increases due to systematic frameworks and computational tools
Solution Approach 1:
The patent creates universal standardized unit operations that can be applied across different bioprocess contexts and scales. These multi-functional building blocks maintain consistent interfaces and parameter structures, enabling reproducible processes while avoiding the need for separate complex frameworks for each specific application.
Solution Approach 2:
The patent replaces manual trial-and-error process development with computational systematic design methods. Software tools automatically assemble and optimize processes using standardized unit operations, reducing the complexity burden on users while improving reliability through algorithmic consistency rather than human judgment variability.
3Manufacturing precision
If extensive resource investment is made in process optimization, then manufacturing precision improves, but loss of time and resources increases due to trial and error development
Solution Approach 1:
The patent performs preliminary systematic optimization through standardized unit operation selection and parameter configuration before actual process implementation. This upfront computational design work identifies optimal parameter combinations and process assemblies, preventing time-consuming trial-and-error adjustments during later development stages.
Solution Approach 2:
The patent enables replication of optimized process designs through standardized unit operation templates and systematic frameworks. Once an optimal process is developed using the standardized approach, it can be copied and reproduced consistently across different facilities and applications, eliminating the need for repeated resource-intensive optimization efforts.
Data Source
AI summary
Methods, systems and apparatus for performing a biological process are provided, wherein the method comprises implementation of at least one unit operation, and wherein the unit operation is defined according to a standardised element structure, the element structure comprising a plurality of functional section blocks, and wherein the section blocks comprise at least one of the group consisting of: imports; parameters; data; physical inputs; requirements; setup; and execution steps.