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Protein Qspec: An Improved Method for Rapid Characterization of Protein Aggregates in Biologic Drugs for Increased Quality and Safety

Award Information
Agency: Department of Commerce
Branch: National Institute of Standards and Technology
Contract: 70NANB16H181
Agency Tracking Number: 049.02.01 (2016)
Amount: $99,993.18
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 9.02.01
Solicitation Number: 2016-NIST-SBIR-01
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-08-01
Award End Date (Contract End Date): 2017-01-31
Small Business Information
3711 Market Street, Suite 970, Philadelphia, PA, 19104-5504
DUNS: 963268151
HUBZone Owned: Y
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Robert Hart
 (215) 970-2685
Business Contact
 Robert Hart
Phone: (215) 253-5777
Research Institution
Optofluidics will develop Protein Qspec, a new particle analysis QC instrument designed to characterize protein aggregates in biologic drugs. The primary concern for this class of therapeutics is that they can elicit an immune response from patients who develop anti-drug antibodies which can eliminate the therapeutic benefit. The presence of particulate matter, in these therapeutics (e.g. shed glass from a syringe or a protein aggregate) enhances this immune response and the FDA therefore regulates the amount of particles that can be present. Although these particles can be counted scientists rarely know what the particles actually are due to lack of effective analysis equipment. The proposed Qspec will fill this need by rapidly capturing particles on a microfabricated sieve followed by rapid FTIR microscopy. Early proof of concept work shows analysis to be about an order of magnitude faster than existing forensic instruments. A QA/QC tool that can identity particles and, if they’re proteins, thoroughly characterize them with spectroscopy, would help pharma companies make better decisions to make stable and safe formulations of biologic drugs as well as detect problems earlier on and forestall manufacturing or safety issues.

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

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