Biologic drugs are therapeutic medicinal products engineered from living cells or proteins. The novel introduction of these products has already had an enormous impact on some medical subfields, including rheumatology, cardiology, oncology, and others. Biologics are, however, very complicated to manufacture, requiring stringent sanitary conditions for cell-production and growth. Small threats to production can create enormous complications in the production chain, potentially producing medication shortages. We have successfully completed all tasks in our Phase I project. In the Phase II project, our goal is to develop a fully automated in-process analyzer to monitor the quantity and quality of biologics. The homogeneous assays to be developed include: quantitative antigen-specific antibody assays, affinity assays, glycosylation assays and aggregation assays. The complete system is expected to be beta-tested by third parties, and the system should be ready for commercialization at the end of the project.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research – Phase II (N44)
Project #
261201200081C-0-0-1
Application #
8565184
Study Section
Project Start
2012-09-28
Project End
2014-09-27
Budget Start
Budget End
Support Year
Fiscal Year
2012
Total Cost
$997,251
Indirect Cost
Name
Mediomics, LLC
Department
Type
DUNS #
100512883
City
Saint Louis
State
MO
Country
United States
Zip Code
63124