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Lateral Flow Immunoassay for Therapeutic Monoclonal Antibody Quality Assurance

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA183241-01
Agency Tracking Number: R43CA183241
Amount: $172,406.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA13-088
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
5448 Pire Ave
San Diego, CA 92122-4126
United States
DUNS: 68800915
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 534-1783
Business Contact
Phone: (858) 824-9253
Research Institution

DESCRIPTION (provided by applicant): Monoclonal antibodies (mAb) are valuable therapeutics for treating cancer and other diseases, but their high cost makes them attractive targets for counterfeiting or illegal distribution. Numerous cases have occurred both in the US and worldwide and the complexity of the pharmaceutical distribution network makes the problem likely to persist. The goal of this project is to develop a simple and inexpensive lateral flow immunoassay that can be used to quickly determine theintegrity of a monoclonal antibody therapeutic. Using mimetope peptides that mimic the native antigen epitope recognized by a give mAb, our test will discriminate between active mAb and other protein or immunoglobulin contaminants. Mimetope peptides havebeen developed for the top three mAb used in oncology: bevacizumab, trastuzumab, and rituximab. The rituximab mimetopes have already been developed in an ELISA format and used for pharmacokinetic studies, the remaining two will be similarly validated in Ai

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

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