Continuous Virus Inactivation Flow With Static Mixer Incubation
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Solution Overview
Problem
Existing methods for inactivating viruses in biological products during manufacturing are inefficient and time-consuming, often requiring multiple discontinuous steps and extended incubation times, and face challenges in controlling light doses and residence times due to flow heterogeneities and micro-heterogeneities, especially when scaling up production.
Innovation Solution
A method involving the continuous combination of a biological product with a virus-inactivation reagent, using a treatment vessel with an internal static mixer, where the composition flows at a predetermined rate and temperature to achieve virus inactivation, with confirmation of the treatment composition's properties before and after processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If discontinuous batch mode is used for virus inactivation, then mixing and incubation can be thoroughly controlled, but processing time is extended and productivity is reduced
Solution Approach 1:
The patent implements continuous flow processing where the biological product continuously flows through the treatment system while maintaining virus inactivation conditions. This eliminates the batch mode stop-start operations, allowing the useful action of virus inactivation to continue without interruption, thereby reducing processing time while maintaining effectiveness
Solution Approach 2:
The patent incorporates a static mixer that pre-mixes the virus inactivation reagent with the biological product before incubation. This preliminary mixing ensures uniform distribution of the reagent throughout the product, eliminating the need for extended mixing and incubation times required in batch mode, thus improving productivity without compromising inactivation effectiveness
2Reliability
If multiple discontinuous steps are used for virus inactivation, then thorough treatment is achieved, but process complexity and time consumption increase
Solution Approach 1:
The patent combines multiple virus inactivation functions into a single continuous flow system. The static mixer and treatment vessel work together as an integrated unit that performs mixing, incubation, and flow control in one continuous process, eliminating the need for multiple separate batch processing steps and reducing overall process complexity
Solution Approach 2:
The continuous flow treatment system serves multiple functions simultaneously: it mixes the reagent with the product, maintains incubation conditions, controls residence time, and ensures uniform treatment throughout. This multi-functional approach replaces multiple specialized batch processing steps, simplifying the overall process while maintaining thorough virus inactivation
3Reliability
If extended incubation time is used for virus inactivation, then complete inactivation is achieved, but manufacturing efficiency is reduced
Solution Approach 1:
The patent changes the incubation parameter from extended static incubation to controlled continuous flow through the treatment vessel. By optimizing the flow rate and residence time in the continuous system, the patent achieves complete virus inactivation in a shorter time period compared to traditional extended batch incubation, thereby reducing time loss while maintaining efficacy
Solution Approach 2:
The patent replaces the mechanical stirring and extended incubation of batch mode with a flow-based continuous processing system. The continuous flow through the treatment vessel with static mixer provides more efficient mass transfer and heat distribution, enabling shorter incubation times to achieve the same level of virus inactivation, thus reducing the time required while maintaining effectiveness
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 approach ensures efficient and continuous virus inactivation with minimal exposure time, maintaining product integrity and reducing process duration, suitable for large-scale manufacturing.
Implementation Method 1
the treatment composition flows at a predetermined rate and contacts the static mixer
Implementation Method 2
incubating the treatment composition in the treatment vessel at a predetermined temperature
Data Source
AI summary
Methods for continuously inactivating virus during manufacture of a biological product are provided. The methods include steps of (1) combining (a) a composition including a biological product, and (b) a composition including a virus-inactivation reagent, to obtain (c) a treatment composition having a predetermined property for inactivation of a virus, (2) confirming that the treatment composition exhibits the predetermined property, (3) transferring the treatment composition to a treatment vessel that includes an inlet, an outlet, and a static mixer, the transferring occurring at the inlet, (4) incubating the treatment composition in the treatment vessel at a predetermined temperature while the treatment composition flows at a predetermined rate and contacts the static mixer, and (5) collecting the treatment composition from the treatment vessel at the outlet, wherein steps (1) to (5) are carried out continuously. Apparatuses and systems including such a treatment vessel are also provided.