Closed Centrifugal Processing Device for Therapeutic Product Washing
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Solution Overview
Problem
Current methods for reconstituting frozen cell therapeutic products are manually intensive, require skilled laboratory technicians, pose biosafety risks, and are not scalable beyond early research use due to the use of openable spin tubes and pipettes.
Innovation Solution
A processing device with integrated first and second compartments, a filtered opening, and a skewed tubular portion for centrifugation, allowing for automated processing and reducing biosafety risks, while maintaining closed system integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pipettes and openable spin tubes are used for manual processing, then flexibility and ease of operation are improved, but biosafety risks increase and scalability decreases
Solution Approach 1:
The processing device is divided into two separate compartments (first compartment for cell therapeutic product, second compartment for suspension solution) that are fluidly connected but physically separated. This segmentation allows independent control of each compartment while maintaining a closed system, eliminating the need for openable tubes and manual pipetting operations that compromise biosafety.
Solution Approach 2:
The first substantially tubular portion is nested within the second substantially tubular portion, creating a compact integrated structure. The filtered opening in the first tubular portion allows fluid communication between compartments while maintaining the nested configuration. This nesting enables automated processing within a closed system that can be safely handled without specialized training.
2Adaptability or versatility
If manual pipetting is used for cryopreservative removal and washing, then adaptability to different protocols is improved, but productivity decreases and skilled workforce dependency increases
Solution Approach 1:
The processing device enables dynamic control of fluid flow between compartments through centrifugation. By adjusting centrifugation parameters (speed, duration), the system can adapt to different processing requirements (cryopreservative removal, washing, concentration) without manual intervention, thereby increasing productivity while maintaining protocol flexibility.
Solution Approach 2:
The device performs washing and cryopreservative removal operations automatically through centrifugal force-driven fluid movement between compartments. The filtered opening enables self-regulated flow where suspension solution automatically mixes with and displaces cryopreservative, eliminating the need for skilled manual pipetting while maintaining processing adaptability.
3Ease of operation
If openable spin tubes are used for processing, then ease of access for multiple operations is improved, but device complexity and environmental control requirements increase
Solution Approach 1:
Multiple operations (thawing, cryopreservative removal, washing, concentration) are merged into a single integrated closed processing device. The first and second compartments work together to perform all these operations without requiring the tube to be opened, thereby reducing environmental control requirements while maintaining ease of access through the closed-port interface.
4Reliability
If repeated manual washing cycles are performed, then therapeutic product purity is improved, but loss of time and productivity worsen
Solution Approach 1:
The centrifugal washing process operates continuously with suspension solution flowing from the second compartment through the filtered opening into the first compartment, displacing cryopreservative in a continuous manner. This eliminates the stop-start nature of manual pipetting and allows multiple washing cycles to be performed in rapid succession, maintaining product purity while significantly reducing processing time.
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
Facilitates automated and scalable processing of therapeutic products, minimizing biocontamination risks and reducing environmental control requirements, suitable for clinical and GMP settings.
Implementation Method 1
the first compartment is in fluid communication with the second compartment via a filtered opening which is arranged in or along the first substantially tubular portion
Data Source
AI summary
A processing device (10) for a therapeutic product or biological sample is provided with a proximal end (12b) and a distal end (12a). The device includes first and second compartments (40, 42) and a first substantially tubular portion (20). The first compartment (40) is in fluid communication with the second compartment (42) via a filtered opening (28) which is arranged in or along the first substantially tubular portion (20). The processing device (10) may be provided in kit form. A method of using the processing device (10) or kit is also disclosed.