Fed-Batch Fermentation Process for Recombinant Protein Production

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Solution Overview

Problem

Existing fed-batch fermentation methods for protein production face challenges such as suboptimal protein yields, inefficient nutrient use, and by-product accumulation, especially when scaling up, due to reliance on feedback control and limited control over specific growth rates and carbon flux.

Innovation Solution

A novel fed-batch method involving continuous addition of a carbon source and an inducer, such as arabinose, after achieving a threshold cell density, allowing for sustained protein production and reducing by-product accumulation, with the inducer being added at a constant rate from 5 g/L to 20 g/L and the carbon source fed concurrently.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If feedback control algorithms are used to control feed rate based on process parameters, then cell activity can be monitored and controlled, but the feed rate becomes sensitive to disturbances and process parameter variations, resulting in distorted feed rates and reduced protein yield

Engineering Contradiction:
Improvecontrol stabilityVSAvoidprotein yield
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent implements a feedback control mechanism where the feed rate is adjusted based on the difference between the actual specific growth rate and the target specific growth rate. This closed-loop control ensures that disturbances and parameter variations are compensated, maintaining stable and reliable feed rate control throughout the fermentation process, thereby resolving the contradiction between control stability and protein yield.

Inventive Principle:
Principle #23Feedback

2Adaptability or versatility

If feedback control is applied to control nutrient supply, then cell activity can be regulated, but the specific growth rate cannot be exactly predefined or controlled, resulting in suboptimal yields in processes where product formation is dependent on growth

Engineering Contradiction:
Improvegrowth rate control flexibilityVSAvoidproduct yield
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The patent directly controls the specific growth rate by adjusting the feed rate based on the difference between actual and target specific growth rates. This parameter control approach allows the specific growth rate to be exactly predefined and maintained, optimizing product formation since the patent explicitly links product yield to growth-dependent processes, thereby resolving the contradiction between growth rate control flexibility and product yield.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If high carbon flux is directed into the central metabolic pathway, then protein production can be enhanced, but by-products may accumulate when the flux exceeds the maximum capacity of the TCA cycle, inhibiting cell growth and protein production

Engineering Contradiction:
Improveprotein production rateVSAvoidby-product accumulation
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent employs feedback control to monitor and adjust the feed rate based on the actual specific growth rate. This prevents excessive carbon flux into the metabolic pathway by maintaining the specific growth rate within optimal ranges, thereby avoiding by-product accumulation that would occur when carbon flux exceeds TCA cycle capacity, while still enhancing protein production through controlled high flux periods.

Inventive Principle:
Principle #23Feedback

4Productivity

If fed-batch fermentation is scaled up to produce increased protein quantities, then production capacity is improved, but disadvantages of feedback control are magnified, affecting process stability and yield

Engineering Contradiction:
Improveprotein production quantityVSAvoidprocess stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent directly controls the specific growth rate parameter by adjusting the feed rate based on the difference between actual and target specific growth rates. This parameter control approach is particularly effective at scale-up because it maintains process stability through direct manipulation of the growth rate, preventing the magnification of feedback control disadvantages that occur in large-scale operations, thereby achieving both high production quantity and process reliability.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method achieves significantly higher protein yields, approximately 2-3 times that of batch fermentation, with reduced by-product accumulation and improved scalability, making it suitable for both small and large-scale commercial production.

Implementation Method 1

an inducible promoter, such as the P_BAD promoter... continuously adding an inducer (such as arabinose) to the culture

Methodology Applied
Scientific EffectInduction:

Implementation Method 2

when carbon flux (for example, high glucose concentration) into the central metabolic pathway exceeds the maximum capacity of the Tricarboxylic Acid (TCA) cycle

Methodology Applied
Scientific EffectFermentation: Fermentation

Data Source

PatentEP2061897B1High-cell density fed-batch fermentation process for producing recombinant protein
Publication Date: 2020.03.25 WYETH LLC
  • EP2061897B1 patent drawingFigure 1~2
  • EP2061897B1 patent drawingFigure 3~4
  • EP2061897B1 patent drawingFigure 5~6

AI summary

Methods for producing proteins, for example, recombinant meningococcal 2086 proteins, using fed-batch fermentation with continuous input of an inducer after achieving a threshold parameter, and optionally continuous input of a carbon source, for example, a constant rate input, to improve protein yields, as well as high density protein compositions and compositions for use in the methods of the present invention, are provided.