Mechanism-informed evaluation of particle formation in high-concentration monoclonal antibodies during fill–finish: Impact of pump materials, surface interactions, and …
1. 文件大小不能超过300M, 允许上传文档或压缩包等
2. 请确保上传文献的真实性、完整性，不得对原文做任何修改
注: 所有应助的资源仅供学习交流使用, 不得违反相关法律法规
DOI:
文献链接:
其他信息:
A Hartman, D Bhattacharya, M Li, V Lin…
Journal of …, 2026
Elsevier
Particle formation during fill–finish operations poses a critical risk to the quality and manufacturability of high-concentration monoclonal antibody drug products. This study systematically evaluates the influence of pump material, clearance tolerance, and flow-path architecture on subvisible and visible particle generation using a model IgG formulation. Controlled simulations compared peristaltic pumping with ceramic and stainless-steel rotary piston pumps under standstill and recirculation conditions, including a configuration …
