Process Analytic Technologies (PAT) for Biologics
Department of Health and Human Services
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Small Business Information
815 WENNEKER DRIVE, SAINT LOUIS, MO, 63124-
Socially and Economically Disadvantaged:
AbstractBiologic 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. The goal of this project is to focus on optimizing the human IgG assay as well as our companion hand-held device for use as a reliable and cost-effective in-process analyzer to monitor the production of biologics. The sensor design blueprint is not specific to any target and thus could be used to develop sensors for not only quantity analysis, but also quality analysis such as the evaluation of the potency, glycosylation and aggregation of various biologics.
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