Process Analytic Technologies (PAT) for Biologics

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N43CO201000040
Agency Tracking Number: N43CO201000040
Amount: $185,116.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NCI
Solicitation Number: PHS2010-1
Small Business Information
DUNS: 100512883
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: Y
Principal Investigator
 Ling Tian
Business Contact
Phone: (314) 997-5918
Research Institution
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. 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.

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

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