Monoclonal Antibody Purification with Standardized Processing Units
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Solution Overview
Problem
Existing monoclonal antibody purification processes require bulky apparatus, extensive infrastructure, complex operation, high operator training, and risk of error due to dissimilar processing units and bioprocessing liquids, leading to increased costs and maintenance complexity.
Innovation Solution
A process utilizing an apparatus with standardized processing units arranged in series, each unit comprising components for inlet, flow control, mixing, and processing, with identical or similar parts to minimize operator error and simplify maintenance, and incorporating chromatography and viral inactivation operations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple different processing units are used for different processing operations, then each operation can be performed with specialized equipment, but the apparatus becomes bulky and requires extensive floor space
Solution Approach 1:
The patent applies universality by designing a single processing unit that can perform multiple different processing operations (chromatography, viral inactivation, ultrafiltration) through configurable components. The unit includes a processing chamber that can be configured with different devices and bioprocessing liquids to perform various operations, eliminating the need for separate specialized equipment for each operation.
Solution Approach 2:
The patent merges multiple processing operations into a single integrated processing unit. The unit combines the processing chamber, flow controller, means for combining liquids, and means for imparting flow into one cohesive structure that can handle chromatography, viral inactivation, and ultrafiltration operations sequentially or concurrently, reducing the overall apparatus footprint.
2Adaptability or versatility
If multiple different processing units are used for different processing operations, then each operation can be performed with specialized equipment, but the interoperability and control of the apparatus becomes inordinately complex
Solution Approach 1:
The single processing unit incorporates universal control mechanisms that can manage different processing operations through a unified interface. The flow controller and means for combining bioprocessing liquids are designed to work across all operation types (chromatography, viral inactivation, ultrafiltration), simplifying interoperability and control compared to managing multiple separate units.
Solution Approach 2:
The processing unit is segmented into distinct functional components (processing chamber, flow controller, mixing means, flow imparting means) that can be independently configured and controlled. This modular segmentation allows each component to be optimized for its specific function while maintaining overall system simplicity through standardized interfaces and control protocols.
3Adaptability or versatility
If multiple different processing units are used for different processing operations, then each operation can be performed with specialized equipment, but operators require extensive training on each type of processing unit
Solution Approach 1:
The single processing unit provides a unified operational interface and control system that works across all processing operations. Operators learn one standardized system rather than multiple different units, reducing training requirements while maintaining the ability to perform chromatography, viral inactivation, ultrafiltration, and other operations through configurable settings and bioprocessing liquids.
4Adaptability or versatility
If multiple different processing units are used for different processing operations, then each operation can be performed with specialized equipment, but a large inventory of spare parts is required
Solution Approach 1:
The single processing unit uses standardized components and bioprocessing liquids across all operations, reducing the variety of spare parts needed. The processing chamber, flow controller, and other components serve multiple functions, eliminating the need to maintain separate inventories for different unit types.
5Adaptability or versatility
If multiple different processing units are used for different processing operations, then each operation can be performed with specialized equipment, but routine maintenance becomes complicated because engineers need to learn how to service processing units of very different construction
Solution Approach 1:
The single processing unit employs standardized construction and components across all processing operations, allowing engineers to learn one maintenance protocol rather than multiple different ones. The processing chamber, flow controller, and other components are designed with consistent interfaces and service procedures regardless of which operation is being performed.
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 simplifies operation, reduces operator error, lowers inventory needs, and simplifies maintenance while maintaining high purification efficiency, making it cost-effective and easier to manage on an industrial scale.
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
Implementation Method 2
the device (iv) in at least one of the at least two processing units performs the processing operation of chromatography
Implementation Method 3
the device (iv) in at least one of the at least two processing units performs the processing operation of viral inactivation
Data Source
AI summary
A process for purifying a liquid feedstock comprising a monoclonal antibody and impurities, the process comprising passing the liquid feedstock through an apparatus comprising at least two processing units, each such unit producing a product stream containing purified monoclonal antibody and optionally a waste stream comprising at least some of the impurities, wherein each unit comprises specified components (i) to (v) which include a multiple inlet flow-controller comprising two or more variable flow inlet valves for in situ production of a bioprocessing liquid by combining at least two liquids in a desired ratio. One of the units performs chromatography and another performs viral inactivation. 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.