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The development of a novel 3D printed prototype device to simplify blood cell subset enrichment at clinical sites Disclosure Number: IPCOM000253189D
Publication Date: 2018-Mar-13
Document File: 4 page(s) / 316K

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Peripheral blood collection is a standard and convenient method to obtain biomarkers during clinical trials. Protein and gene expression changes can be used to assess drug response, target engagement, and disease state changes. For gene expression analysis, whole blood can be collected in buffers that lyse the cells and protect RNA from degradation. Though the separation of specific subsets may increase cell specific signals compared to an unpurified cell mixture, it does require instrumentation and trained personnel not readily available at many clinical sites, and shipping to a processing lab is costly and may affect the results. Therefore, a way to enrich for and stabilize blood cell subsets at the site of collection is needed. We have developed a portable 3D printed prototype device that can be operated with minimal training and does not require additional specialized instruments. Blood is collected into a tube containing commercially available polystyrene spheres (PluriSelect) coupled to an antibody specific for a blood cell surface antigen. After a 10 min incubation at room temperature, the tube is inserted into the device, followed by a single washing step. Between the inlet and outlet is a mesh with pores that are smaller than the polystyrene beads. All of the blood cells attached to the beads will remain on the mesh, while the unbound cells will pass through the filter. Using anti‐CD3 antibodies, we were able to use FACS to verify that the prototype device is capable of enriching more than 1,000,000 CD3+ cells from 2 ml of whole blood with 90% purity. At a clinical site these cells can be collected and processed at room temperature with minimal manipulation and stored in appropriate buffer and transported. This prototype device may enable cell type‐specific analysis for pharmacokinetic/pharmacodynamic assessments and biomarker discovery.

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The development of a novel 3D printed prototype device to simplify  blood cell subset enrichment at clinical sites. 

Peripheral blood collection is a standard and convenient method to obtain biomarkers during clinical trials.  Protein and  gene expression changes can be used to assess drug response, target engagement, and disease state changes.  For gene  expression analysis, whole blood can be collected in buffers that lyse the cells and protect RNA from degradation. Though  the separation of specific subsets may increase cell specific signals compared to an unpurified cell mixture, it does require instrumentation and trained personnel not readily available at many clinical sites, and shipping to a processing lab is costly  and may affect the results.  Therefore, a way to enrich for and stabilize blood cell subsets at the site of collection is needed.   We have developed a portable 3D printed prototype device that can be operated with minimal training and does not require  additional specialized instruments.  Blood is collected into a tube containing commercially available polystyrene spheres  (PluriSelect) coupled to an antibody specific for a blood cell surface antigen.  After a 10 min incubation at room  temperature, the tube is inserted into the device, followed by a single washing step.  Between the inlet and outlet is a mesh with pores that are smaller than the polystyrene beads.  All of the blood cells attached to the beads will remain on the  mesh, while the unbound cells will pass through the filter.  Using anti‐CD3 antibodies, we were able to use FACS to verify  that the prototype device is capable of enriching more than 1,000,000 CD3+ cells from 2 ml of whole b...