MEDIOMICS, LLC — Department of Health and Human Services SBIR Phase II: Biologic drugs are therapeutic medicinal products engineered from living cells or proteins

Description

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.