Implementing Continuous Manufacturing for the Final Methylation Step in the AMG 397 Process to Deliver Key Quality Attributes
09 Jun 2023 | Contributor(s):: Tom, JK, Achmatowicz, MMBeaver, MG, Colyer, J, Ericson, A, Hwang, TL, Jiao, N, Langille, NF, Liu, M, Lovette, MA, Sangodkar, RP, Kumar, SS, Spada, S, Perera, D, Sheeran, J, Campbell, K, Doherty, T, Ford, DD, Fang, YQ, Rossi, E, Santoni, G, Cui, S, Walker, SD
In this article, we describe the process development efforts to improve the final methylation step in the AMG 397 drug substance process, culminating in the execution of a Good Manufacturing Practice (GMP) continuous manufacturing process. During the development, batch kinetic studies and...