ArticlemAbs2026
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.
Article in mAbs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
9 authors.
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Abstract
Fluorescence molecular imaging using fluorescently labeled antibodies enables identification of target cells and provides pharmacological insight into local drug distribution. The current GMP manufacturing method of tracers using PD-10 columns is subject to methodological constraints when handling low antibody concentrations, large quantities, or incompatible antibodies. This study presents Tangential Flow Filtration (TFF) as a novel and scalable approach to manufacture clinical-grade fluorescent tracers and demonstrates its applicability using cetuximab-800CW and ustekinumab-800CW. TFF system settings were optimized for purification of cetuximab-800CW and ustekinumab-800CW with labeling parameters and quality control similar to tracer production with PD-10 columns. Cetuximab-800CW production was successfully transitioned from PD-10 to TFF. QC-data after manufacturing with TFF (
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