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A Label-free Extracellular-vesicle Automated Purification System (LEAP System)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43GM144009-01
Agency Tracking Number: R43GM144009
Amount: $197,500.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA20-260
Timeline
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-01
Award End Date (Contract End Date): 2022-02-28
Small Business Information
930 CORAL RIDGE CIR
Rodeo, CA 94572-1808
United States
DUNS: 081096834
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 YUCHAO CHEN
 (814) 777-8586
 yuchaochen@wellsimbiotech.com
Business Contact
 YUCHAO CHEN
Phone: (814) 777-8586
Email: yuchaochen@wellsimbiotech.com
Research Institution
N/A
Abstract

PROJECT SUMMARY / ABSTRACT
Extracellular vesicles (EVs) are small lipid bilayer particles secreted by most cell types, which encapsulates
biomolecules including lipids, proteins, and nucleic acids from parent cells. Profiling of EV-derived biomarkers
provides a promising approach for early diagnoses and prognosis of various diseases. Currently, one of the
primary hindrances to the implementation and usage of EVs is lack of a robust method for convenient and high-
speed isolation of EVs with high yield and purity. A number of recent publications mentioned that developing
efficient and reliable isolation methods is urgent to further advance in this field. There is a strong desire to explore
innovated technologies for better performance of EV isolation in terms of throughput, purity, yield, speed,
robustness, and cost. To overcome these challenges, WellSIM Biomedical Technologies proposes to develop,
optimize, and validate a Label-free Extracellular-vesicle Automated Purification System (LEAP System) for EV
isolation from bodily fluids (e.g., plasma and urine) with excellent performance. Based on our current prototype
which has shown competitive EV yield, purity, and isolation efficiency, we will further improve the processing
speed, sample volume load, and throughput by redesigning and optimizing the System. Our preliminary studies
support that, with the proposed improvement, we can expect to simultaneously isolate EVs from up to 6 plasma
samples (andgt;2 mL) within 1 hr with purity and yield outperform other EV isolation methods. After system upgrade
and optimization, we will comprehensively validate our next-generation platform with cell culture medium, urine,
and plasma in terms of yield, purity, speed, and processing volume. Our new platform will directly address the
current bottlenecks, and thus provide an advanced EV purification tool for EV-based life science and precision
medicine.PROJECT NARRATIVE
Extracellular vesicles (EVs) are small lipid bilayer particles secreted by most cell types. Profiling of EV-derived
biomarkers provides a promising approach for diagnosis of various diseases. However, one of the primary
hindrances to the study and application of EVs is lack of a robust method for convenient and high-speed isolation
of EVs with high yield and purity. A number of recent publications mentioned that developing efficient and reliable
isolation methods is urgent to further advance in this field. To overcome the critical biological and technical
hurdles, we propose to develop, optimize, and validate a Label-free Extracellular-vesicle Automated Purification
System (LEAPS) with excellent EV-isolation capability over the other technologies.

* Information listed above is at the time of submission. *

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