Journal
CONTRAST MEDIA & MOLECULAR IMAGING
Volume 7, Issue 6, Pages 516-524Publisher
WILEY-HINDAWI
DOI: 10.1002/cmmi.1484
Keywords
cGMP-compatible synthesis; near-infrared fluorophore; near-infrared fluorescence imaging; optical imaging
Funding
- National Institutes of Health: NCI BRP [R01-CA-115296]
- NIBIB [R01-EB-010022, R01-EB-011523]
- Dana Foundation
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Image-guided surgery using optical imaging requires the availability of large quantities of clinical-grade fluorophores. We describe the cGMP-compatible synthesis of the zwitterionic heptamethine indocyanine near-infrared fluorophore ZW800-1 at the 10 g scale (similar to 1000 patient doses) using facile and efficient solvent purification, and without the need for column chromatography. ZW800-1 has >90% yield at the final step and >99% purity as measured by fluorescence and evaporative light scatter detection. We describe an analytical framework for qualifying impurities, as well as a detailed analysis of counterion identities. Finally, we report the unique in vivo properties of ZW800-1 in large animals approaching the size of humans, thus laying the foundation for rapid clinical translation of these methods. Copyright (c) 2012 John Wiley & Sons, Ltd.
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