Functionalized Nonwoven Filter for Biologic Harvesting
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Solution Overview
Problem
Current biopharmaceutical manufacturing methods require multiple stages for primary clarification of intracellularly expressed biomolecules, involving cell disruption and subsequent purification, which is inefficient and costly, especially due to challenges with particle size distribution and detergent removal.
Innovation Solution
A method using a functionalized nonwoven filter medium for sequential lysis and clarification, where cells are captured and disrupted by osmotic pressure changes, allowing for simultaneous retention of debris and recovery of the biological product in a single device, eliminating the need for additional reagents and clarification steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional multi-stage filtration and cell disruption methods are used, then purification of intracellular biomolecules is achieved, but process complexity and cost increase significantly
Solution Approach 1:
The patent combines cell capture, cell disruption, and clarification functions into a single filter device. The filter medium performs multiple operations simultaneously: capturing cells via size exclusion, disrupting cells through mechanical shear forces during filtration, and clarifying the lysate by retaining debris. This eliminates the need for separate centrifugation, lysis, and filtration steps, directly resolving the contradiction between purification effectiveness and process complexity.
Solution Approach 2:
The filter device is designed as a multi-functional unit that performs cell capture, cell disruption, and clarification in one operation. The filter medium serves multiple purposes: it acts as a size-exclusion barrier for cell capture, generates mechanical shear for cell lysis, and functions as a clarification medium for debris retention. This universal design allows a single device to replace multiple specialized equipment, reducing overall process complexity while maintaining purification effectiveness.
2Manufacturing precision
If multiple clarification steps are implemented, then product purity is improved, but processing time and productivity are reduced
Solution Approach 1:
The filter device performs cell capture and preliminary disruption actions before the main clarification step. By capturing cells on the filter medium first and then disrupting them in-situ during the same operation, the system eliminates the need for separate pre-treatment steps. This preliminary integration of functions allows rapid processing while achieving high product purity, as all clarification actions occur in a single continuous operation rather than multiple sequential steps.
3Manufacturing precision
If centrifuges and conventional depth filters are used for primary clarification, then cell separation is achieved, but equipment cost and operational complexity increase
Solution Approach 1:
The patent extracts the cell separation function from complex equipment like centrifuges and reduces it to a simple filtration process. By using size-exclusion filtration as the primary separation mechanism, the system eliminates the need for expensive centrifugal equipment while achieving equivalent or superior cell separation efficiency. The filter device captures cells based on size differences alone, providing a simpler, more cost-effective solution that maintains high separation efficiency.
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 simplifies the clarification process, reduces the need for multi-stage filtration, and effectively captures and concentrates the product while retaining debris and soluble impurities, enhancing the efficiency and scalability of biologic harvesting.
Implementation Method 1
The filter medium can comprise a functionalized nonwoven and methods provided herein can utilize the filter medium to capture and disrupt cells and/or retain debris and soluble impurities
Implementation Method 2
The functionalized nonwoven can comprise a charged depth filter device
Implementation Method 3
passing a second fluid, and optionally a third and/or fourth fluid through the filter medium, wherein the second and/or third and/or fourth fluid disrupts at least one of the captured cells
Data Source
AI summary
A method. The method includes providing a filter medium comprising a functionalized nonwoven; passing a first fluid containing cells through the filter medium, wherein at least some of the cells are captured by the functionalized nonwoven; passing a second fluid, and optionally a third and/or fourth fluid through the filter medium, wherein the second and/or third and/or fourth fluid disrupts at least one of the captured cells; and recovering an intracellular biological product in the first and/or second and/or third and/or fourth fluid.