Dual-Pump Cell Harvesting for Continuous Concentration and Formulation
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Solution Overview
Problem
The current process for producing cell-based drugs is cumbersome, inefficient, and costly due to manual calculation and operation when dealing with large volumes of cell fluids, particularly during concentration and formulation processes.
Innovation Solution
A dual pump harvesting method utilizing two pumps with a flow rate difference to achieve continuous flow concentration and formulation, including circulating continuous flow concentration and formulation processes, minimizing manual intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual calculation and operation are used for large volumes of cell fluids, then flexibility and simplicity are maintained, but efficiency and accuracy deteriorate
Solution Approach 1:
The system divides the concentration and formulation processes into distinct operational phases handled by two pumps working in sequence. The first pump handles initial concentration by transferring cell fluid to centrifugal containers, while the second pump handles formulation by transferring concentrated cells to final containers. This segmentation allows automated high-throughput processing without requiring a single complex monolithic system.
Solution Approach 2:
The dual pump system is designed to perform multiple functions: concentration, centrifugation, formulation, and waste removal all within a single integrated platform. The pumps can be programmed with different flow rates and operational parameters to adapt to various cell types and processing requirements, providing universal applicability across different cell therapy products.
2Productivity
If high flow rate concentration is implemented, then productivity is improved, but cell damage may increase
Solution Approach 1:
The system employs dynamic flow rate adjustment where the first pump operates at high flow rates for rapid concentration, while the second pump uses lower flow rates during formulation to minimize cell stress. The centrifugal containers rotate at controlled speeds to enhance separation efficiency without excessive mechanical stress on cells. This dynamic parameter optimization maintains high productivity while protecting cell viability.
Solution Approach 2:
Centrifugal containers serve as intermediary devices between the two pumps, providing a gentle separation mechanism that reduces direct mechanical stress on cells during the concentration process. The centrifugal force field separates cell fluid from supernatant without the high shear forces that would occur in direct filtration or high-speed pumping, thus protecting cells while maintaining processing efficiency.
3Manufacturing precision
If circulating continuous flow concentration is used, then accuracy and yield are improved, but process complexity increases
Solution Approach 1:
The system implements continuous flow concentration where the first pump continuously transfers cell fluid through centrifugal containers to the second pump, which continuously formulates the concentrate into final products. This eliminates batch processing interruptions and ensures consistent flow rates throughout the process, improving formulation accuracy and cell yield through uninterrupted processing.
Solution Approach 2:
The control system monitors flow rates, volumes, and process parameters in real-time, adjusting pump operations to maintain precise formulation specifications. Sensors detect cell concentration levels and fluid volumes, providing feedback to the control system which automatically adjusts pumping rates to achieve target cell densities and volumes in final containers, ensuring high manufacturing precision.
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
Significantly improves the efficiency and accuracy of cell drug production by enabling high-flow rate concentration and formulation, reducing cell damage, and enhancing yield and viability.
Implementation Method 1
one end of a first pump of the two pumps is connected to an initial sample container and an other end of the first pump is connected to a centrifugal container; the first pump extracts an initial sample from the initial sample container into the centrifugal container for centrifugation
Implementation Method 2
one end of a second pump of the two pumps is connected to the centrifugal container and an other end of the second pump is connected to an intermediate container and a waste liquid container; the second pump pumps a supernatant in the centrifugal container into the waste liquid container
Data Source
Figure 1
AI summary
The present disclosure provides a dual pump harvesting process including a concentrating process and a formulating process. Two pumps are used to perform the concentrating process. One end of a first pump of the two pumps is connected to an initial sample container and an other end of the first pump is connected to a centrifugal container; one end of a second pump of the two pumps is connected to the centrifugal container and an other end of the second pump is connected to an intermediate container and a waste liquid container. A flow rate difference between the two pumps during concentration is set to be a flow rate threshold, and a flow rate of the second pump is higher than that of the first pump to perform a continuous flow concentration. The present disclosure also provides a dual pump harvesting apparatus.