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Software for Determining Proteoform Heterogeneity and Protein Expression Fidelity

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM131533-01
Agency Tracking Number: R41GM131533
Amount: $225,285.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-01-01
Award End Date (Contract End Date): 2020-01-31
Small Business Information
657 GEORGE ST, Montara, CA, 94037-0645
DUNS: 610426038
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 SCOT WEINBERGER
 (650) 238-7180
 sweinberger@gnxtech.com
Business Contact
 SCOT WEINBERGER
Phone: (650) 238-7180
Email: sweinberger@gnxtech.com
Research Institution
 UNIVERSITY OF GEORGIA
 TUCKER HALL 310 EAST CAMPUS RD ROOM 409
ATHENS, GA, 30602-1589
 Nonprofit college or university
Abstract
The importance of large protein drugsbiopharmaceuticalsand their generic counterpartsknown as biosimilarshas created a need for improved analytics to facilitate biopharmaceutical research and to combat adverse drug reactionsThe recombinant protein expression process is inherently prone to low level errors resulting in sequence variants caused by amino acid misincorporationwhich are observed in both native and expressed proteinsThe expression system and culturing conditions can influence protein product quality attributessuch as translational fidelity and post translational modificationsThese protein variantsthose arising from sequence variants and post translational modificationsimpact product quality in a number of ways that include altered functionactivityligand substrate bindingand perturbed protein folding leading to protein aggregationdecreased serum half lifeand diminished therapeutic efficacy to name but a few consequencesAn additional concern for biopharmaceuticals is that sequence variants can potentially induce an undesired immune responseWorries for efficacy and patient safety necessitates the need to characterize these low level protein variantsThe detection and quantification of protein variants are challenging currently extremely challengingThe goal of this Phase I STTR will evaluate the feasibility of a new software package to identify and quantify low level protein variantsUpon successful completion of our programwe will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research The importance of large protein drugsbiopharmaceuticalsand their generic counterpartsknow as biosimilarshas created a need for improved analytics to facilitate biopharmaceutical research and to combat adverse drug reactionsThe biopharmaceutical industry acknowledges the critical role that protein heterogeineity plays in the safety and function of biotherapeuticsThis Phase I STTR will demonstrate feasibility of an new software package to identify and quantify low level protein variantsUpon successful completion of our programwe will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research

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

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