Standardized Biomolecule Purification Units for Simpler Bioprocessing

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Solution Overview

Problem

Existing biomolecule purification processes require bulky apparatus, extensive infrastructure, complex operation, high risk of operator error, and diverse spare parts due to dissimilar processing units, complicating maintenance and increasing costs.

Innovation Solution

A process involving a series of integrated processing units with standardized components and flow paths, including steps for cell removal and concentration, followed by chromatographic purifications, to produce a purified target substance with reduced operator error and simplified maintenance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If dissimilar processing units are used for different processing operations, then each operation can be performed with specialized equipment, but the apparatus becomes bulky, requires extensive floor space, and complicates maintenance

Engineering Contradiction:
Improveprocessing operation specializationVSAvoidfloor space requirement
Core Design Contradiction:
Adaptability or versatilityVSArea of stationary object

Solution Approach 1:

The patent applies universality by designing a single processing unit that can perform multiple different processing operations (chromatography, filtration, concentration, viral inactivation) through configurable components. The unit includes a processing chamber that can be configured with different media and a control system that can execute different processing protocols, allowing one physical unit to replace multiple specialized units.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent merges multiple processing operations into a single integrated unit. The processing unit combines chromatography capabilities, filtration capabilities, concentration capabilities, and viral inactivation capabilities in one apparatus, eliminating the need for separate bulky units for each operation and reducing overall floor space requirements.

Inventive Principle:
Principle #5Merging (Combining)

2Adaptability or versatility

If dissimilar processing units are used for different processing operations, then each operation can be performed with specialized equipment, but the apparatus becomes complex to operate and maintain

Engineering Contradiction:
Improveprocessing operation specializationVSAvoidoperational complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The control system provides a unified interface for operating all processing operations. A single control system executes different processing protocols for chromatography, filtration, concentration, and viral inactivation, eliminating the need for operators to learn multiple different control systems and reducing operational complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The processing unit incorporates self-cleaning and self-diagnostic capabilities that automatically maintain the system without requiring extensive manual intervention. The system can automatically perform cleaning cycles and monitor its own operational status, reducing the complexity of maintenance procedures.

Inventive Principle:
Principle #25Self-service

3Adaptability or versatility

If dissimilar processing units are used for different processing operations, then each operation can be performed with specialized equipment, but more inventory of spare parts is required

Engineering Contradiction:
Improveprocessing operation specializationVSAvoidspare parts inventory
Core Design Contradiction:
Adaptability or versatilityVSQuantity of substance

Solution Approach 1:

The processing unit uses a standardized set of components that serve multiple functions. The processing chamber, filters, membranes, and other critical components are designed to be universal parts that can be used across different processing operations, reducing the variety of spare parts that need to be inventoried.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system incorporates reusable components that can be regenerated and reused multiple times. For example, chromatography media and filters can be regenerated through automated cleaning processes, reducing the frequency of replacement and the need for spare parts inventory.

Inventive Principle:
Principle #34Discarding and recovering

4Adaptability or versatility

If dissimilar processing units are used for different processing operations, then each operation can be performed with specialized equipment, but routine maintenance becomes complicated

Engineering Contradiction:
Improveprocessing operation specializationVSAvoidmaintenance simplicity
Core Design Contradiction:
Adaptability or versatilityVSEase of repair

Solution Approach 1:

The processing unit is designed with standardized components and a unified maintenance protocol. Engineers can service all processing operations (chromatography, filtration, concentration, viral inactivation) using the same knowledge and tools, as the unit presents a consistent interface and maintenance procedure regardless of which processing operation is being performed.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system includes automated self-diagnostic and self-cleaning functions that reduce the need for manual maintenance intervention. The control system can automatically detect issues and perform routine cleaning cycles, simplifying the maintenance burden on engineers.

Inventive Principle:
Principle #25Self-service

5Adaptability or versatility

If different processing liquids are used for different processing operations, then each operation can be optimized with appropriate buffers, but the risk of operator error increases

Engineering Contradiction:
Improveprocessing operation optimizationVSAvoidoperator error risk
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The control system incorporates sensors and feedback mechanisms that automatically monitor the processing liquids and buffers being used. The system can verify that the correct liquid is being used for each operation and provide automatic alerts or corrections if an error is detected, reducing the risk of operator error while maintaining optimization.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system automatically manages the processing liquids through integrated reservoirs and delivery systems. The control system can automatically prepare, deliver, and monitor the appropriate buffers and liquids for each processing operation, eliminating manual intervention and reducing the risk of operator error while maintaining optimal processing conditions.

Inventive Principle:
Principle #25Self-service

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

The process achieves efficient, cost-effective, and simplified biomolecule purification with reduced operator error, lower inventory needs, and easier maintenance, while maintaining high purification efficiency.

Implementation Method 1

a multiple inlet flow-controller comprising two or more variable flow inlet valves for producing a bioprocessing liquid from at least two other liquids to be combined in a desired ratio

Methodology Applied
Scientific EffectFluid mixing:

Implementation Method 2

at least one of said units is a unit for performing chromatographic purification of the target substance

Methodology Applied
Scientific EffectChromatography: Chromatography

Data Source

PatentEP4013528B1Process for purifying target substances
Publication Date: 2026.02.25 FUJIFILM DIOSYNTH BIOTECH UK
  • EP4013528B1 patent drawingFigure 1
  • EP4013528B1 patent drawingFigure 2
  • EP4013528B1 patent drawingFigure 3

AI summary

A process for purifying a composition comprising water, a target substance, impurities and optionally cells, the process comprising the steps (A) and (B): (A) preparing a liquid feedstock by performing step (Ai) and/or (Aii) on the composition: (Ai) removing at least some of the cells from the composition; (Aii) concentrating the composition by removing water therefrom; and (B) passing the liquid feedstock through an apparatus comprising at least two processing units, each such unit producing a product stream containing purified target substance and optionally a waste stream comprising at least some of the impurities, wherein each unit comprises specified components (i) to (v). The units may be essentially the same except for a device they contain, leading to advantages in terms of simplicity, cost and ease of operation, lower risk of operator error, easier maintenance and lower inventory of spare parts.