Panitumumab-IRDye800 was produced under GMP at the Leidos Biomedical Research Center (Frederick, MD). IRDye800CW-NHS (IRDye800CW-N-hydroxysuccinimide ester; LI-COR Biosciences) as a fluorescent probe with a NIR absorption and emission peak of 778 nm/794 nm as discussed previously (17 (link),20 (link),21 (link)). Briefly, panitumumab (Vectibix; Amgen, Thousand Oaks, CA, USA; 147 kDa) was conjugated to IRDye800CW-NHS by a 2-hour incubation at 20°C in the dark with a dye to protein ratio of 2.3:1. Quality control of the conjugate included analysis of drug product in sterile vial for particulates, and integrity of the sterilizing filter. Upon production and vialing, vials were transported to Stanford University where they were stored at the Stanford Health Care Investigational Pharmacy.
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Panitumumab-IRDye800 GMP Production
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Corresponding Organization : Stanford University
Other organizations : Leiden University Medical Center, University of Alabama at Birmingham
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Variable analysis
independent variables
- Panitumumab-IRDye800 concentration
- Dye to protein ratio
- Particulates in the drug product
- Integrity of the sterilizing filter
- Incubation time (2 hours)
- Incubation temperature (20°C)
- Lighting conditions (dark)
- Quality control of the conjugate (analysis of drug product in sterile vial for particulates, and integrity of the sterilizing filter)
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