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Development of a Pharmacokinetic (PK) Mouse Serum GLP ELISA for an Anti-CD19-AntiCD3 Diabody

Johnson, T.; Ahnoud, A.; DiNello, B.; ralph, p.; Cripe, T. P.; Wang, P.-Y.; Weiss, T. L.

2025-03-19 immunology
10.1101/2025.03.19.644217 bioRxiv
Show 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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