Development of a scalable manufacturing process
How GRA assisted in the development of a scalable purification process for a novel live attenuated viral vaccine for First-in-Man trials.
Immunoassay Diagnostics Device Development
Situation
Dr. Lee Smith was asked by an Asian diagnostic device developer to work as an interim CEO to assist them in the development, patenting and marketing of a low cost point-of-care immunotesting device based upon a disposable credit card size test card and reading device that could be ready for regulatory approval and partnering.
GRA Involvement
- Market review and biomarker identification
- Device design and development
- Patent fillings
- Assay development
- Product marketing and partnering
Value Added
The commercial opportunity was assessed and a device was designed based upon the market review and patents filed (WO2011123064 A1) for the device. Three immunoassays were developed in the card (CK, MB, TnI). A video explaining the technology was written and produced. GRA helped lead the launch the device at the American Association of Clinical Chemistry, Atlanta, USA 2012. Several potential international partners were identified who were interested in adopting the technology platform.
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