Kinetic studies and CFD-based reaction modeling for insights into the scalability of ADC conjugation reactions.

ABSTRACT: The manufacturing of antibody-drug conjugates (ADCs) involves the addition of a cytotoxic small-molecule linker-drug (= payload) to a solution of functionalized antibodies. For the development of robust conjugation processes, initially small-scale reaction tubes are used which requires a lot of manual handling. Scale-up to larger reaction vessels is often knowledge-driven and scale-comparability is solely assessed based on final product quality which does not account for the dynamics of the reaction. In addition, information about the influence of process parameters, such as stirrer speed, temperature, or payload addition rates, is limited due to high material costs. Given these limitations, there is a need for a modeling-based approach to investigate conjugation scale-up. In this work, bo

SUBMITTER: Weggen JT 

PROVIDER: S-EPMC10111256 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature