Cell Culture Scale-Up Data Collection for Shear and Nutrient Control
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Solution Overview
Problem
The existing scale-up methods for cell culture processes face challenges in maintaining productivity and quality due to the inability to account for parameters specific to scale-up, leading to unexpected issues during the transition from laboratory to large-scale production.
Innovation Solution
A culture scale-up culture data collection device and method that evaluates both first and second explanatory variables, including parameters specific to scale-up, to optimize culture conditions and prevent unexpected problems by incorporating a cell number control unit, nutrient component concentration control, shear force control, and waste product concentration control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional scale-up methods are used to maintain geometric similarity and constant power per unit liquid volume, then stirring conditions can be maintained, but it is difficult to satisfy all scale-up items simultaneously and productivity and quality may be compromised
Solution Approach 1:
The patent changes the approach from maintaining geometric similarity to maintaining specific parameter relationships. It introduces the concept of maintaining constant power per unit liquid volume and specific shear force ranges, allowing flexible adjustment of other parameters like tank dimensions and stirring speeds while ensuring critical culture conditions are met.
Solution Approach 2:
The patent focuses on maintaining only the most critical scale-up items (power per unit liquid volume, shear force range) rather than all geometric similarities simultaneously. This partial action approach allows practical scale-up while ensuring productivity and quality are maintained.
2Reliability
If culture experiments are performed again in large scale to collect data for scale-up, then scale-up can be performed, but the period required for construction of production process becomes long
Solution Approach 1:
The patent performs preliminary data collection and process optimization in small-scale culture experiments before large-scale production. By collecting and analyzing data from small-scale experiments, the critical parameters (power per unit liquid volume, shear force) are determined in advance, allowing direct progression to large-scale production without time-consuming re-experiments.
Solution Approach 2:
The patent uses small-scale culture experiments as simplified copies of the large-scale production process. By optimizing the process in these smaller representative systems first, the same optimization can be applied to the large-scale system, eliminating the need for separate large-scale experimentation for data collection.
3Adaptability or versatility
If the range of culture performance is set wide on small scale, then culture can be performed, but the range is often narrowed in large scale due to unevaluated factors
Solution Approach 1:
The patent implements feedback by measuring actual culture performance parameters (productivity, quality, cell density, metabolite concentrations) in small-scale experiments and using this information to adjust and refine the scale-up conditions. This iterative feedback process ensures that the culture performance range maintained in small scale translates reliably to large scale.
Solution Approach 2:
The patent replaces mechanical geometric similarity constraints with physiological parameter maintenance. Instead of focusing on mechanical aspects like tank geometry and stirring speed ratios, it focuses on maintaining physiological conditions (power per unit liquid volume, shear force range, temperature, pH) that directly affect culture performance, thereby maintaining adaptability across scales.
Data Source
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AI summary
The invention provides a culture scale-up culture data collection device and a culture scale-up culture data collection method that can prevent unexpected problems in productivity and quality after scale-up. The invention provides a culture scale-up culture data collection device (1) for searching for a scale-up condition of a cell culture device. The device has a first function related to a first explanatory variable associated with the cell culture device after scale-up, and a second function related to a second explanatory variable, which correlates with an objective variable but is not associated with the cell culture device after the scale-up. Both the first function and the second function are optimized for the objective variable.