Development of production methodologies for scFv-Fc conjugated critical reagents to support CAR-T clinical programs.

ABSTRACT:

Introduction

Routine conjugation protocols are typically used by bioanalytical laboratories for production of their assay critical reagents. Novel molecules can pose unique challenges to the production of high-quality conjugated critical reagents required for clinical bioanalytical assays. Using routine conjugation protocols, we observed gross instability of conjugated-drug surrogate material for use in antidrug antibody (ADA) assays in clinical autologous Chimeric Antigen Receptor (CAR)-T cell programs, thus halting assay development.

Methods

We highlight our approach in developing process conditions for CAR-T supporting conjugated critical reagents, where recombinant CAR scFv-hFc is the surrogate drug material to be conjugated. We show that when routine platform process ap

SUBMITTER: O'Connor E 

PROVIDER: S-EPMC12785195 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature