Rey, Guillaume, Schuetz, Fabienne, Schroeder, Daniela, Kaluschke, Christian, Wendeler, Markus, Hofmann, Irmgard, Dumbliauskaite, Eva and Obrdlik, Petr (2024) Automated ELISA for Potency Measurements of Therapeutic Antibodies and Antibody Fragments. Journal of pharmaceutical and biomedical analysis, 245. ISSN Journal of Pharmaceutical and Biomedical Analysis 245 (2024) 116141

Abstract

Potency assays are essential for the development and quality control of biopharmaceutical drugs, but they are often a time limiting factor due to manual handling steps and consequently low analytical throughput. On the other hand, automation of potency assays can be challenging due to their complexity and the use of biological materials. ELISA (enzyme-linked immunosorbent assay) is widely used for potency determination and is a good candidate for automation as all ELISA types depend on the same basic steps: coating, blocking, sample incubation, detection, and signal measurement. Nevertheless, potency ELISA methods still require drug-specific development and assay validation thereby complicating automation efforts. To simplify potency testing by ELISA, we first developed a manual protocol generally applicable to different drugs and then adapted this protocol for automated measurements. We describe the critical parameters which had to be adapted to transfer the manual ELISA to an automated liquid handling system and demonstrate that gravimetric sample dilution is unnecessary with the automated protocol. Both manual and automated protocols were validated and compared using multiple biotherapeutics. The automated protocol showed lower variability and higher accuracy than the manual method.

Item Type:	Article
Keywords:	ELISA, potency, automation, therapeutic proteins, biologics, gravimetric dilution.
Date Deposited:	11 Jul 2024 00:46
Last Modified:	11 Jul 2024 00:46
URI:	https://oak.novartis.com/id/eprint/52977