Journal: International Journal of Pharmaceutics: X

Article Title: Roadmap for the accelerated development and clinical translation of fluorescent tracers: Adalimumab-680LT as a proof of concept

doi: 10.1016/j.ijpx.2026.100514

Figure Lengend Snippet: Results for the feasibility testing and lab development of adalimumab-680LT . SE-HPLC chromatograms of (A) unmodified adalimumab and (B) adalimumab-680LT at 280 nm, (C) chromatogram of adalimumab-680LT and free IRDye 680LT at 676 nm and (D) results of the indirect ELISA of unmodified adalimumab and adalimumab-680LT.

Article Snippet: Briefly, to remove excipients in the solution and to optimise the pH for labelling, adalimumab registered product (Humira®, AbbVie) was buffer exchanged to a 50 mM sodium phosphate buffer pH 8.5 (Apotheek A15, Gorinchem, the Netherlands) using pre-equilibrated PD-10 columns (Cytiva lifesciences, Chicago, IL, USA). cGMP grade IRDye 680LT NHS-ester (LI-COR Biosciences, Lincoln, NE, USA), dissolved in dimethyl sulfoxide (DMSO) (Sigma Aldrich, Darmstadt, Germany) 5 mg/mL, was added to the adalimumab solution in a molar dye-to-protein ratio of 2:1.

Techniques: Indirect ELISA

Journal: International Journal of Pharmaceutics: X

Article Title: Roadmap for the accelerated development and clinical translation of fluorescent tracers: Adalimumab-680LT as a proof of concept

doi: 10.1016/j.ijpx.2026.100514

Figure Lengend Snippet: Stability results of adalimumab-680LT. Release specifications are displayed with dotted lines, and end of shelf-life specifications are displayed with dashed lines. (A) Protein concentration, (B) percentage of free dye, (C) percentage of aggregates, and (D) target binding affinity of lab run 1 and 2 were tested during 3 months. For the technology transfer batch, (E) protein concentration, (F) percentage of free dye, (G) percentage of aggregates and (H) target binding affinity were tested at two different temperatures during 18 or 24 months. The stability study of the technology transfer batch at 2–8 °C is still ongoing. (A-C) are means of two different measurements, ( E -G) are means + standard deviations of three different measurements, and (D and H) are means of two measurements.

Article Snippet: Briefly, to remove excipients in the solution and to optimise the pH for labelling, adalimumab registered product (Humira®, AbbVie) was buffer exchanged to a 50 mM sodium phosphate buffer pH 8.5 (Apotheek A15, Gorinchem, the Netherlands) using pre-equilibrated PD-10 columns (Cytiva lifesciences, Chicago, IL, USA). cGMP grade IRDye 680LT NHS-ester (LI-COR Biosciences, Lincoln, NE, USA), dissolved in dimethyl sulfoxide (DMSO) (Sigma Aldrich, Darmstadt, Germany) 5 mg/mL, was added to the adalimumab solution in a molar dye-to-protein ratio of 2:1.

Techniques: Protein Concentration, Binding Assay