Mechanism-informed evaluation of particle formation in high-concentration monoclonal antibodies during fill–finish: Impact of pump materials, surface interactions, and …
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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 …
