Journal: mAbs

Article Title: Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept

doi: 10.1080/19420862.2026.2743444

Figure Lengend Snippet: SE-HPLC chromatograms of cetuximab-800CW purified with PD-10 columns and TFF. Chromatograms after cetuximab-800CW purification using PD-10 columns (A–C) or using TFF (D–F) at (A, D) 280 nm, (B, E) 775 nm, and (C, E) 780 nm.

Article Snippet: For cetuximab-800CW, recombinant human EGFR (Sino Biologicals Europe GmbH, 10,001-H02H) was used as antigen, and a dilution series (0.5 to 3000 ng/mL) of both the commercially available cetuximab and cetuximab-800CW was used.

Techniques: Purification

Journal: mAbs

Article Title: Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept

doi: 10.1080/19420862.2026.2743444

Figure Lengend Snippet: Quality control test results of cetuximab-800CW produced with either the PD-10 column or TFF purification method. Quality controls of TFF and PD-10 bulk productions were compared, and p-values were adjusted for multiple comparisons using the Holm-Šídák method. Label efficiency (Holm-Šídák adjusted p < 0.001) and yield (Holm-Šídák adjusted p=0.021) were compared with Welch’s t-test. Cetuximab-800CW concentration was compared using an independent-samples t-test (Holm-Šídák adjusted p=0.021), and unconjugated IRDye 800CW was compared using a Mann-Whitney U test (Holm-Šídák adjusted p=0.003, Hodges-Lehmann estimate of between-group difference 0.530, CI 0.367-0.751). * = p < 0.05, ** = p < 0.01, *** = p < 0.001.

Article Snippet: For cetuximab-800CW, recombinant human EGFR (Sino Biologicals Europe GmbH, 10,001-H02H) was used as antigen, and a dilution series (0.5 to 3000 ng/mL) of both the commercially available cetuximab and cetuximab-800CW was used.

Techniques: QC/EQA/Proficiency, Produced, Purification, Concentration Assay, Mann-Whitney U-Test, Bioburden Testing

Journal: mAbs

Article Title: Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept

doi: 10.1080/19420862.2026.2743444

Figure Lengend Snippet: Stability data of cetuximab-800CW purified with PD-10 columns or TFF. Release specifications are displayed with dotted lines, and end‑of‑shelf-life specifications are displayed with dashed lines. Stability data of one batch purified with PD-10 and the mean and standard deviation of three batches produced with TFF are shown. For every batch, measurements at each time point are performed in triplicate to quintuplicate. (A) cetuximab-800CW concentration, (B) percentage of free dye, (C) percentage of aggregates, and (D) target binding affinity.

Article Snippet: For cetuximab-800CW, recombinant human EGFR (Sino Biologicals Europe GmbH, 10,001-H02H) was used as antigen, and a dilution series (0.5 to 3000 ng/mL) of both the commercially available cetuximab and cetuximab-800CW was used.

Techniques: Stability, Purification, Standard Deviation, Produced, Concentration Assay, Binding Assay

Journal: mAbs

Article Title: Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept

doi: 10.1080/19420862.2026.2743444

Figure Lengend Snippet: Microscopic analysis (40×) of particle formation. (A) particle formation of ustekinumab-800CW in the technology transfer batch. (B) microscopic picture of a cetuximab-800CW batch with no particles.

Article Snippet: For cetuximab-800CW, recombinant human EGFR (Sino Biologicals Europe GmbH, 10,001-H02H) was used as antigen, and a dilution series (0.5 to 3000 ng/mL) of both the commercially available cetuximab and cetuximab-800CW was used.

Techniques: Analysis

Journal: mAbs

Article Title: Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept

doi: 10.1080/19420862.2026.2743444

Figure Lengend Snippet: Schematic overview of the TFF setup used in the manufacturing of cetuximab-800CW and ustekinumab-800CW. Buffers, antibody, and antibody–dye conjugate are introduced into the feed reservoir to enter the system. The feed reservoir is connected to a filter unit, with tubes leading through a pump to control the flow of the system. The filter unit has two exit ports, one for the permeate, leading to a waste container, and one for the retentate, leading back to the feed reservoir. The permeate tube can be closed to form a closed loop for stabilization of the system, while opening the permeate tube allows the system to start filtering. The TMP is controlled with a clamp and measured with pressure transducers.

Article Snippet: For cetuximab-800CW, recombinant human EGFR (Sino Biologicals Europe GmbH, 10,001-H02H) was used as antigen, and a dilution series (0.5 to 3000 ng/mL) of both the commercially available cetuximab and cetuximab-800CW was used.

Techniques: Control

Journal: mAbs

Article Title: Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept

doi: 10.1080/19420862.2026.2743444

Figure Lengend Snippet: Optimal TFF system parameters for cetuximab-800CW production.

Article Snippet: For cetuximab-800CW, recombinant human EGFR (Sino Biologicals Europe GmbH, 10,001-H02H) was used as antigen, and a dilution series (0.5 to 3000 ng/mL) of both the commercially available cetuximab and cetuximab-800CW was used.

Techniques: Buffer Exchange