bioRxiv · 10.1101/2025.03.19.644217
Development of a Pharmacokinetic (PK) Mouse Serum GLP ELISA for an Anti-CD19-AntiCD3 Diabody
Abstract
GP101 is a single chain diabody composed of Fv regions of antibodies directed to CD3 and CD19. It is designed to mimic commercial blinatumomab (Blincyto(R)) that simultaneously co-engages patient T lymphocytes and CD19 positive B cell leukemias and lymphomas, facilitating their targeted destruction. This study details the purification of GP101 protein and development of a highly sensitive ELISA for its detection, achieving a sensitivity of 15pg/mL in 25% mouse serum. This ELISA has been validated according to GLP standards.
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Johnson, T., Ahnoud, A., DiNello, B., ralph, p., Cripe, T. P., Wang, P.-Y., Weiss, T. L.. 2025-03-19. Development of a Pharmacokinetic (PK) Mouse Serum GLP ELISA for an Anti-CD19-AntiCD3 Diabody. https://doi.org/10.1101/2025.03.19.644217
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