Perfusion Bioprocess Control With Predictive Chromatography Coupling

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Solution Overview

Problem

Existing bioprocess control methods, particularly in perfusion bioreactors, struggle with cyclic behavior and inability to adapt to metabolic shifts, leading to unstable process performance and inefficiencies in cell culture and downstream product purification.

Innovation Solution

A model predictive control approach that integrates a dynamic model of the bioprocess with a predictive model of downstream chromatographic processes to optimize manipulated variables, considering operational constraints and economic costs, using a state observer and machine learning for metabolic parameter estimation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If simple PID control loops are used to control feed flow rate, bleed flow rate, and harvest flow rate, then the control implementation is straightforward and easy to operate, but the process exhibits cyclic behavior and cannot adapt to metabolic shifts, resulting in unstable process performance

Engineering Contradiction:
Improvecontrol implementation simplicityVSAvoidprocess stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent transitions from fixed-parameter PID control to dynamic parameter control through model predictive control. The system continuously adjusts control parameters based on real-time state estimates and predicted process behavior, enabling adaptation to metabolic shifts while maintaining stability. The objective function and constraints are dynamically updated based on chromaticography predictions, allowing the system to respond to changing process conditions without cyclic behavior.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If simple PID control loops are used to control feed flow rate, bleed flow rate, and harvest flow rate, then the control implementation is straightforward and easy to operate, but the process exhibits cyclic behavior and cannot adapt to metabolic shifts, resulting in unstable process performance

Engineering Contradiction:
Improvecontrol implementation simplicityVSAvoidadaptation to metabolic shifts
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent implements a closed-loop feedback system where state observers continuously estimate process variables, and model predictive control uses these estimates to predict future behavior and adjust control actions. The system incorporates feedback from chromaticography predictions to adapt to metabolic shifts, creating a responsive control mechanism that maintains adaptability while managing complexity through structured algorithms.

Inventive Principle:
Principle #23Feedback

3Reliability

If model predictive control is used to determine adjustments of manipulated variables, then process stability is improved and cyclic behavior is eliminated, but the system complexity increases due to integration of dynamic models and optimization algorithms

Engineering Contradiction:
Improveprocess stabilityVSAvoidcontrol system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces state observers as intermediary components that bridge the gap between simple measurements and complex control requirements. These observers estimate unmeasured process variables and provide refined state information to the model predictive control system, reducing the direct complexity burden. The chromaticography predictions serve as another intermediary layer that translates process states into actionable constraints and objectives, managing system complexity through structured intermediate processing steps.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of manufacture

If upstream cell culture process is operated without coordination with downstream product purification, then the upstream process can be optimized independently for cell growth and productivity, but the overall system efficiency is reduced due to mismatches in operational parameters

Engineering Contradiction:
Improveindependent process optimizationVSAvoidoverall system efficiency
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent merges upstream cell culture control with downstream chromaticography optimization into a unified model predictive control system. The chromaticography predictions provide feedback to the upstream process control, creating coordinated operation where both processes are optimized simultaneously. The objective function integrates both upstream productivity goals and downstream operational constraints, ensuring that feed flow rate, harvest flow rate, and other manipulated variables are adjusted to maximize overall system efficiency rather than just upstream performance.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP4610345A1Control of continuous bioprocesses
Publication Date: 2025.09.03 SARTORIUS STEDIM DATA ANALYTICS AB
  • EP4610345A1 patent drawingFigure 1
  • EP4610345A1 patent drawingFigure 2A
  • EP4610345A1 patent drawingFigure 2B

AI summary

The present disclosure provides methods, systems and products for controlling a bioprocess comprising a cell culture in a bioreactor, wherein the bioprocess is operated as a perfusion bioprocess. the methods use a model predictive control to identify values of manipulated variables that optimise an objective function, the objective function including one or more constraints and/or one or more terms that are associated with predictions obtained from a method of simulating a chromatographic process that is coupled with the bioprocess for processing of a harvest stream of the bioprocess.