Fully closed cell sorter for immune cell therapy manufacturing

Area of Science:

• Biotechnology
• Immunology
• Cell Biology

Background:

• Specific immune cell phenotypes are critical for sustained remission in adoptive immune cell therapies.
• Clinical application requires current Good Manufacturing Practice (cGMP)-compliant cell sorting with multiparameter selection.

Purpose of the Study:

• To develop a cGMP-applicable, fully closed cell sorter for isolating specific immune cell phenotypes.
• To evaluate the sorter's efficiency, purity, viability, and impact on cell functionality.

Main Methods:

• Development of a microfluidic cell sorter utilizing a suction mechanism and multiparameter detection with two laser optical settings.
• Application of negative pressure at the sorting point to enhance cell isolation.
• Assessment of sorting rate, purity, yield, viability, and functionality of sorted gene-modified T cells.

Main Results:

• The microfluidic sorter achieved an effective rate of 7,000 sorts per second.
• High purity (85.5%), effective yield (77.1%), and viability (93.7%) were obtained for the target cell population.
• Sorted gene-modified T cells retained essential functionalities, including proliferation, antigen recognition, cytokine release, and cytotoxicity.

Conclusions:

• The developed closed cell sorter meets cGMP requirements for clinical applications.
• This technology enables efficient and high-quality isolation of immune cells for adoptive cell therapies.
• The sorter preserves the functional integrity of gene-modified T cells, supporting their therapeutic potential.