Rapid identity testing of antibody-based hot targeted radionuclide therapies by bio-layer interferometry

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 246; p. 116227
• Main Authors: Durous, Laurent, Géraudie, Solène, Andersen, Lene, Schulte, Saskia, Hunnes, Iris, Hildebrand, Dominic G., Traenkle, Jens, Glück, Julian Marius
• Format: Journal Article
• Language: English
• Published: England Elsevier B.V 15.08.2024
• Subjects: Bio-layer interferometry; Biosensing Techniques - methods; Humans; Identity testing; Interferometry - methods; Radioisotopes - chemistry; Radiopharmaceuticals - chemistry; Targeted radionuclide therapies; Bio-layer interferometry; Targeted radionuclide therapies; Identity testing
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2024.116227

Targeted Radionuclide Therapies (TRT) involve the tailored combination of a therapeutic radionuclide and a targeting molecule, as for instance antibodies or fragments thereof. Despite their short shelf-life, these drug products must meet stringent regulatory standards before use. We introduce a novel, efficient method utilizing Bio-Layer Interferometry (BLI) for rapid identity testing of TRT drug products in less than five minutes. This approach not only reduces radioactive waste but also minimizes operator exposure to radiation. This label-free method has been successfully developed and validated for three different TRT products, ensuring compliance with Good Manufacturing Practices (GMP). Furthermore, we outline our strategic approach to the production and testing of custom biosensors for each product, firmly grounded in Quality-by-Design (QbD) principles. [Display omitted] •Bio-Layer Interferometry allows rapid identity testing of radiolabeled antibody drug products.•The method was successfully validated for several products demonstrating its applicability in a GMP regulated environment.•Production and testing of product-specific biosensors following Quality-by-Design principles.