Sterile and disposable fluidic subsystem suitable for clinical high speed fluorescence-activated cell sorting

Area of Science:

• Biotechnology
• Cell Biology
• Medical Devices

Background:

• Fluorescence-activated cell sorting (FACS) is crucial for cell isolation, culture, and transplantation.
• Standard flow cytometers lack aseptic design, risking sample contamination.
• Sterile conditions are essential for clinical applications of sorted cells.

Purpose of the Study:

• To design and test a sterile, disposable fluid handling system for FACS.
• To meet good manufacturing practice requirements for high-speed cell sorting.
• To ensure the sterility of isolated cells for clinical use.

Main Methods:

• Developed a modular, sterile, and disposable fluid handling system for a cytometer.
• Modified existing flow cytometer hardware for aseptic operation.
• Tested the system's functionality and ability to maintain a sterile fluid environment.

Main Results:

• The new fluidic subsystem replicated the performance of standard systems.
• Effectively isolated fluids from contaminants including bacteria, fungi, endotoxins, and mycoplasma.
• Demonstrated successful maintenance of a clean and sterile fluid environment.

Conclusions:

• Aseptic FACS instrument configurations are necessary for clinical stem cell applications.
• The developed disposable sterile fluid handling system addresses this need.
• Enables full utilization of stem cell discoveries in transplant medicine.