Viral Filter Chase Fluid Continuous Flow
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Solution Overview
Problem
Current methods for removing viruses from cell culture fluids used in recombinant protein production are inefficient and can result in reduced product purity due to interruptions in fluid flow across viral filters, which impairs viral removal and does not meet Good Manufacturing Practices (GMP) standards effectively.
Innovation Solution
A method involving continuous flow of process fluid through a viral filter, with the addition of a chase fluid to maintain flow and prevent interruptions, ensuring sufficient fluid volume to avoid air entry and maintaining differential pressure within optimal limits to achieve effective viral reduction without significant impairment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If virus removal is performed using a viral filter, then viral particles are removed from the process fluid, but flow interruptions occur which impair viral removal efficiency
Solution Approach 1:
The patent applies preliminary action by adding a chase fluid to the reservoir before the process fluid is completely filtered. This ensures that continuous flow is maintained through the viral filter throughout the entire filtration process, preventing flow interruptions that would otherwise occur when the reservoir empties. The chase fluid is added in advance to guarantee sufficient fluid volume for complete viral particle removal.
Solution Approach 2:
The patent implements continuity of useful action by ensuring uninterrupted flow through the viral filter. The system is designed so that process fluid flows continuously from the reservoir through the viral filter to the destination, and the chase fluid is added to maintain this continuous flow until all viral particles have been removed. This eliminates periods where flow stops or slows, which would compromise viral removal efficiency.
2Reliability
If chase fluid is added to maintain continuous flow, then viral removal efficiency is optimized, but additional fluid volume and handling complexity increase
Solution Approach 1:
The patent applies self-service by using the chase fluid to serve dual purposes: it maintains continuous flow through the viral filter for optimal viral removal, and it also serves as the final eluent that carries any remaining viral particles through the filter. The chase fluid essentially cleanses the system itself, eliminating the need for separate additional steps to ensure complete viral particle removal.
Solution Approach 2:
The patent changes the parameter of fluid volume in the reservoir by adding the chase fluid. This parameter change ensures that sufficient fluid volume is maintained throughout the filtration process to prevent flow interruptions. The system transitions from a decreasing fluid volume (as process fluid is filtered) to a maintained or increased fluid volume (when chase fluid is added), ensuring continuous flow conditions.
3Productivity
If flow rate is increased to improve productivity, then more fluid is processed faster, but flow interruptions become more likely impairing viral removal
Solution Approach 1:
The patent applies preliminary action by calculating and adding the appropriate volume of chase fluid before high-rate filtration begins. This ensures that even at increased flow rates, the reservoir will not empty during the filtration process, maintaining continuous flow conditions throughout. The chase fluid volume is determined in advance based on the reservoir volume and filtration requirements.
Solution Approach 2:
The patent implements continuity of useful action by designing the system to maintain uninterrupted flow even at high productivity rates. The chase fluid ensures that the reservoir maintains sufficient volume throughout the entire filtration process, preventing any flow interruptions or air entry into the viral filter, thereby maintaining optimal viral removal efficiency throughout high-rate operation.
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 optimizes viral removal by maintaining continuous flow and preventing interruptions, achieving significant reductions in viral particles while ensuring product purity and compliance with GMP standards, thereby enhancing the quality and safety of recombinant protein therapeutics.
Implementation Method 1
pass a viral filter to produce eluent
Data Source
AI summary
Disclosed are methods and devices for the optimization of virus removal from solutions. A method of filtering a process fluid comprising a product includes allowing some of the process fluid to flow from a first reservoir to a viral filter; adding a chase fluid to the process fluid in the first reservoir to form a composite fluid; and allowing the composite fluid to flow from the first reservoir to the viral filter to produce eluent. In some embodiments, flow of fluid across the viral filter is sufficient to avoid significant impairment to viral removal until a preselected event, occurs. In some embodiments, flow of fluid from the first reservoir across the viral filter is maintained in the absence of an interruption or slowing of flow of duration or magnitude sufficient to impair viral removal to a level below a log-reduction value of the viral filter.