Evaluate a novel product to simultaneously remove dead cells, cellular membranes,

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$147,923.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43GM100504-01A1
Award Id:
n/a
Agency Tracking Number:
R43GM100504
Solicitation Year:
2012
Solicitation Topic Code:
NIGMS
Solicitation Number:
PA11-096
Small Business Information
80 WEBSTER ST, WORCESTER, MA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
9796223
Principal Investigator:
CHRISTOPHER REINHARDT
(508) 770-1190
cs@biopal.com
Business Contact:
CHRISTOPHER REINHARD
(508) 770-1190
cs@biopal.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): We hypothesize that a commercially competitive magnetic nanoparticle can be developed to eliminate debris in the preparation of cell cultures, such as stem cells. Current methods to remove unwanted material from healthycultures rely on magnetic negative selection using Annexin V-based magnetic particles. Annexin V binds to the phospholipid phosphatidylserine (PS) present on the surface of dead cells and cell membrane fragments. A magnetic field is then applied to collect dead cells from the healthy culture. Although commercially successful, Annexin V-based technology has significant drawbacks: (i) it is restricted to removing only PS-containing membranes, (ii) stripped nuclei and oligonucleotides cannot be removed, (iii)Annexin V cannot be autoclaved, (iv) Annexin V activity can degrade over time, (v) Annexin V requires calcium-containing buffers, (vi) is difficul to use in serum, (vii) is inherently unstable due to the sloughing of Annexin V, (viii) is likely t have high endotoxin levels, (ix) is expensive to manufacture and maintain, therefore adding significant cost to the end- user. Our proposed product will eliminate dead cells and cell membrane fragments from culture as effectively as Annexin V-based magnetic particles. Our product will also (i) target and eliminate nucleic acids, (ii) provide greater flexibility in buffe selection, and (iii) tolerate autoclaving to assure sterility. Because the conditions under which a cell sample is prepared will become more stringent as technologies mature into clinical practice, successful completion of this application will have a profound and positive impact on many sectors of biomedicine, including reproductive medicine, diagnostic applications and cell therapy, such as autologus stem cell therapy. PUBLIC HEALTH RELEVANCE: The project will evaluate a novel technology to remove unwanted and harmful debris from healthy cell cultures. Because the conditions under which a cell sample is prepared will become more stringentas technologies mature into clinical practice, our product will have a profound and positive impact on many sectors of biomedicine, including reproductive medicine, diagnostic applications and cell therapy.

* information listed above is at the time of submission.

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