Abstract:During fill-finish manufacturing, protein-pump surface interactions can induce subvisible particle (SVP) formation which poses a risk to drug product quality and patient safety. Despite this risk, there have been no concerted efforts to understand the effects of piston pump design on SVP formation.We've systematically varied the design of the piston-cylinder interface to minimize SVP formation for a therapeutic immunoglobulin. The clearance factor, surface roughness factor, and their combined interaction signi… Show more
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