Article Figures & Data
Figures
- FIGURE 1.
Optical tracer development and translation roadmap showing critical activities, tests, and reports to properly translate product to cGMP. BSE = bovine spongiform encephalopathy; IMPD = investigational medicinal product dossier; IPC = in-process control; IRB = institutional review board; MBR = master batch record; QC = quality control; TSE = transmissible spongiform encephalopathy.
- FIGURE 2.
Formulation study results for cetuximab-800CW and trastuzumab-800CW. Protein monomer concentration (A and B) and main impurity in both products (C and D) are shown. Monomer concentration data are normalized to first measurement to show relative protein breakdown. Formulations considered feasible for development are shown in color; unfeasible formulations are shown in gray scale. Dashed and dotted lines indicate acceptance limits for product release or end of shelf-life. RL = release limit; SL = (end of) shelf-life limit.
- FIGURE 3.
Cetuximab-800CW and trastuzumab-800CW main stability results. (A and B) Monomer concentration. Data are normalized to average measured at start of study to show relative protein breakdown. (C and D) Unconjugated dye, presented as percentage of total IRDye 800CW. (E) Soluble protein aggregates for trastuzumab-800CW. No aggregates were detected during stability study for cetuximab-800CW. Dashed and dotted lines show acceptance limits for product release and end of shelf-life. Data are presented as averages with 95% confidence interval for 5 measurements. RL = release limit; SL = (end of) shelf-life limit.
- FIGURE 4.
Representative binding curves for target affinity ELISA for cetuximab-800CW (A) and trastuzumab-800CW (B) after 3 mo of refrigerated storage. Black symbols and curve indicate reference standard of unlabeled antibody. Data are presented as average and SD of duplicate measurements. OD450 = absorption at 450 nm.
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