ABREOS BIOSCIENCES, INC. — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Monoclonal antibodies (mAb) are valuable therapeutics

ABREOS BIOSCIENCES, INC. — SBIR Phase I award from Department of Health and Human Services.

Amount
$172,406
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
SBIR · Phase I
Solicitation
PA13-088
NAICS
Place of performance
CA
Period

Description

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