# High Efficiency Microfluidic Device for Large Scale CAR-T Cell Manufacturing

> **NIH NIH R43** · CG SCIENTIFIC, INC. · 2020 · $385,433

## Abstract

Project Summary/Abstract
The goal of this project is to develop a high-yield microfluidic device for enriching white blood cells
(WBCs) from leukapheresis products, for use in manufacturing CAR-T and other cancer cellular
immunotherapies. CD19-targeted CAR-T cell therapy is highly effective and FDA-approved for treating
advanced hematologic malignancies, and over 300 active clinical trials are currently using CAR-T cells to
target various cancers, including solid tumors. Large-scale production of cellular immunotherapy,
including CAR-T cell therapy, poses a unique challenge due to the fact that each therapy is custom-
manufactured from the cancer patient’s own WBCs, collected using leukapheresis. Because cancer
patients often have low WBC counts and inconsistent peripheral access, their leukapheresis harvests are
frequently limited in WBC quantities and highly contaminated with red blood cells (RBCs). There is a
critical need for high-yield enrichment of the WBC source material for CAR-T cell manufacturing. CG
Scientific is developing a cost-effective device that enriches WBCs with high yields, based on its
patented microfluidic “High Efficiency Deterministic Separation (HEDS)” technology. The technology
aims to (1) provide high WBC recovery that is essential to cellular cancer immunotherapy, and (2)
overcome the cost and throughput issues that have precluded other microfluidic cell separation
technologies from successful commercialization. Preliminary data have shown that HEDS is capable of
delivering >95% WBC recovery and >98% RBC removal, with undetectable loss of cell viability—
significantly outperforming existing WBC enrichment systems. The unique configuration of HEDS can
potentially provide scalable processing throughput, resistance to clogging, and capability to operate by
gravity feed. To further establish the feasibility of HEDS technology for cell manufacturing, this Phase I
project will focus on 3 Specific Aims: (1) optimize HEDS chip design and develop Chip Packs to scale up
processing throughput, (2) demonstrate high WBC recovery yields and characterize the enriched WBCs
and T cell subsets using flow cytometry and T cell proliferation assay, and (3) demonstrate plastic HEDS
chip manufacturability using soft embossing. The investigator team includes the inventor of the HEDS
technology, immunology biologists, plastic device manufacturing engineers, and medical doctors who
specialize in cellular therapy and cell manufacturing. The success of this project will lead to a high-yield
WBC enrichment device that will significantly improve the source material for cellular immunotherapies,
make the cell manufacturing process more robust and reliable, and eventually provide more potent and
cost-effective targeted cancer therapies that will benefit many patients.

## Key facts

- **NIH application ID:** 10077471
- **Project number:** 1R43CA254490-01
- **Recipient organization:** CG SCIENTIFIC, INC.
- **Principal Investigator:** Lotien Richard Huang
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $385,433
- **Award type:** 1
- **Project period:** 2020-09-21 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10077471

## Citation

> US National Institutes of Health, RePORTER application 10077471, High Efficiency Microfluidic Device for Large Scale CAR-T Cell Manufacturing (1R43CA254490-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10077471. Licensed CC0.

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