Integrated Point-of-Care Platform for 5–7-Hour Cell Therapeutic Production
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Solution Overview
Problem
Current manufacturing processes for cell therapeutics are time-consuming, requiring multiple instruments and sterile environments, leading to increased costs and inefficiencies.
Innovation Solution
A system comprising a suspension preparation, cell-deformation, dilution, incubation, cell-washing, and container-filling subsystems, capable of processing cells in a non-sterile environment, which includes components like microfluidic chips and tangential flow filtration, to produce cell therapeutics in about 5 to 7 hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional manufacturing processes are used for cell therapeutics, then cell therapies can be produced, but the process takes days to weeks and requires multiple instruments and sterile environments, greatly increasing time and cost
Solution Approach 1:
The patent combines multiple separate manufacturing instruments and processes into a single integrated device that can perform cell isolation, suspension, deformation, dilution, incubation, washing, and container-filling operations sequentially within one platform. This merging eliminates the need for multiple separate instruments and reduces the overall manufacturing time from days to weeks down to a single day.
Solution Approach 2:
The manufactured device is designed as a universal platform capable of performing multiple different cell processing functions using a single device. It can isolate cells, create suspensions, deform cells for payload entry, dilute suspensions, incubate cells at controlled temperatures, wash cells, and fill containers - replacing the need for multiple specialized instruments with one multi-functional system.
2Productivity
If multiple instruments and sterile environments are used for cell therapeutic manufacturing, then cell therapies can be produced, but the physical space requirements and facility costs increase significantly
Solution Approach 1:
The patent consolidates multiple separate manufacturing instruments into one integrated device, thereby reducing the physical footprint required for manufacturing. Instead of requiring separate clean rooms and facilities for each instrument, the combined device can be housed in a single location with minimal space requirements.
Solution Approach 2:
The device incorporates temperature control capabilities that allow it to perform incubation and other temperature-sensitive operations without requiring a controlled sterile environment. By actively controlling temperature parameters, the device can maintain appropriate conditions for cell processing in a non-sterile setting, eliminating the need for expensive clean room facilities.
3Adaptability or versatility
If multiple separate instruments are used for cell processing, then various cell operations can be performed, but the setup and cleaning time for each instrument greatly adds to production time
Solution Approach 1:
The patent integrates multiple cell processing functions into a single device with shared components and fluid pathways. This eliminates the need to set up and clean multiple separate instruments for each processing step. The device can transition between different operations (isolation, suspension, deformation, dilution, incubation, washing, filling) without requiring instrument changes or extensive cleaning between steps.
Solution Approach 2:
The device is designed to perform operations in a continuous or near-continuous manner, with fluid pathways and processing chambers that allow seamless transition between steps. Cells can flow continuously through different processing zones without interruption, eliminating the downtime associated with setting up and cleaning separate instruments between operations.
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 system significantly reduces processing time and eliminates the need for multiple instruments and sterile facilities, enabling efficient production of cell therapeutics in a non-sterile setting.
Implementation Method 1
one or more cell-deforming constrictions configured to cause perturbations in cell membranes of the cells to allow entry of a payload into the cell
Implementation Method 2
a plate configured to adjust the temperature of the diluted cell suspension in the container to create an incubated cell suspension
Implementation Method 3
one or more pumps configured to pump the cells suspended in preservation media into the one or more containers
Data Source
AI summary
The present disclosure generally relates to a systems and methods for processing cells, and kits for use with such methods and processes. In some aspects, the system, methods, and processes can be used to produce cell therapeutics.