# Microfluidic CAR-T Cell Processing Device

> **NIH NIH R42** · GPB SCIENTIFIC, INC. · 2020 · $913,556

## Abstract

ABSTRACT
The goal of this Fast-Track STTR project is to develop a Deterministic Lateral Displacement (DLD)
microfluidic device that can enrich white blood cells (WBCs) from a typical leukapheresis unit in 1 hr,
for use in manufacturing cancer cellular immunotherapy. Chimeric antigen receptor T cell (CAR-T) therapy
has been recommended for FDA approval to treat relapsed or refractory pediatric and young adult patients with
B-cell acute lymphoblastic leukemia. There is a critical need for cost-effective automated methods to improve
the efficiency and yield of large-scale enrichment of WBCs for use in manufacturing CAR-T and other cellular
therapies.
GPB is a pioneer in developing novel DLD microchips to process blood cells for cell analysis (19,26). GPB now
proposes to develop, evaluate and commercialize a compact device in which an entire leukapheresis unit (up
to 5x1010 WBCs in up to 300 ml) can be processed in a “Leuko-stack” of disposable single-use multi-channel
DLD chips to produce in 1 hr a washed cell suspension that is enriched in WBCs and depleted of red blood
cells (RBCs) and platelets (PLT).
In Phase I, Aim 1 is to increase cell throughput through the current prototype chips by: 1) optimizing DLD chip
design and operation to increase flow rate; 2) increasing throughput by stacking plastic chips and running them
in parallel (“Leuko-stacks”); and 3) translating chip production to high-volume manufacturing material such as
Cyclic Olefin Polymer (COP). Final Phase I milestones to proceed to Phase II are: 1) final chip design with a
flow rate of at least 25 mL/hr via a single chip, at least 70% recovery of viable WBCs and immunophenotype-
defined T-lymphocytes, and ability to process cells for 1 hr without clogging; 2) Leuko-stack of at least 6 chips
run in parallel, with the same output as in #1; 3) combined increases in throughput via #1 and #2 sufficient to
process a 300 ml leukapheresis unit in 1 hr; 4) confirmation that the chips can be produced from COP.
In Phase II, Aim 2 is to build final prototype COP plastic chip-based microfluidic device capable of processing a
leukapheresis sample at 300 mL/hr. Aim 3 is to test performance of prototypes from Aim 2 with leukapheresis
aliquots and then full-size human leukapheresis samples. The final milestone of this project is to produce a
set of commercial prototype Leuko-stacks that can process an entire 300-ml leukapheresis unit in 1 hr
with at least 70% WBC and T-lymphocyte recovery, at least 90% depletion of RBCs, at least 80%
depletion of PLTs, and at least 70% recovery of T-cell expansion capacity (as compared with the input
samples) in significantly more than 50% of samples tested at 2 sites.
The GPB Leuko-stack platform will preserve the advantages of DLD microfluidic cell processing over current
methods, while massively increasing throughput rate and cell processing capacity, thus transitioning from
analytic- to preparative-scale WBC enrichment for subsequent manufacture of CAR-T and ot...

## Key facts

- **NIH application ID:** 9935016
- **Project number:** 5R42CA228616-03
- **Recipient organization:** GPB SCIENTIFIC, INC.
- **Principal Investigator:** CURT I CIVIN
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $913,556
- **Award type:** 5
- **Project period:** 2018-04-17 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9935016

## Citation

> US National Institutes of Health, RePORTER application 9935016, Microfluidic CAR-T Cell Processing Device (5R42CA228616-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9935016. Licensed CC0.

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