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Development and validation of a cell separation platform technology

Award Number: R33HL183009
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Development and validation of a cell separation platform technology - PROJECT SUMMARY / ABSTRACT The objective of the proposed project is to further develop an enabling, platform technology to help researchers more easily isolate cells of interest from blood samples. While major feasibility gaps have already been overcome, additional work on these cell separation devices is required to translate the current pilot prototype design into a mass-manufacturable embodiment which still retains the unprecedented capabilities that have been established to date. These include removal of ~99% of red blood cells and platelets from whole blood samples, as well as the separation of ~95% monocytes and granulocytes from the lymphocyte / stem cell population. The ability to process standard whole blood draws – rather than depending on expensive units of mononuclear cells that were harvested via leukapheresis, or the purchase of frozen aliquots of these units – to acquire the initial starting material with which to perform R&D on cellular therapies would foster research in the basic, translational, and clinical sciences related to a variety of blood diseases and disorders. These include, for example, the acquisition of (i) peripheral blood stem cells in order to perform CRISPR-style research on sickle cell anemia, thalassemia, and other inherited blood disorders, (ii) monocytes with which to perform extracorporeal photopheresis to investigate or treat an array of different conditions, including graft versus host disease and cutaneous T cell lymphoma, and (iii) lymphocytes for the development of adoptive cell-based therapies. The proposed project is aimed at increasing the readiness level of the novel flow-through cell separation technology described, by first producing thermoplastic device prototypes, to be manufactured via high-volume commercial techniques, and then validating in particular their ability to concentrate the CD34+ stem cell population in whole blood samples by ~100X, while processing an entire 500mL unit of cold-stored whole blood in 2 hours. Single- use thermoplastic devices will be driven by a basic, off-the-shelf peristaltic pump as with prior prototypes, which further ensures this platform technology will be amenable to widespread adoption, without the significant equipment cost expenditure required by existing automated methods. The ‘debulking’ of whole blood samples, to remove the overwhelming number of interfering cells (largely red cells and platelets) and enable the selection of rarer cells of interest, while seemingly a simple task is in reality a significant challenge – one which presently has no ready solution that does not involve undesirable chemical gradients or lysis steps. A transformative methodology that is wholly different from the inadequate, currently-available approaches is needed in order to improve the pace and quality of groundbreaking R&D efforts, and help enable cell-based therapies to fulfill their immense potential.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $351,949 )
2026	2026	HALCYON BIOMEDICAL INC	2319 BRIGHTON PARK LN	FRIENDSWOOD	TX	77546	GALVESTON	USA	Blood Diseases and Resources Research	000	1	9/4/2026	NEW	$351,949
														Subtotal = $351,949

Grand Total All Awards = $351,949

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Development and validation of a cell separation platform technology

Award Number: R33HL183009

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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