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Subvisible Particles in Biopharmaceuticals: Causes, Analytical Methods and Ways of the Suppression
Tuesday, March 09, 2021: 9:05 AM - 9:40 AM
Speaker(s)
Description
It has been recently recognized that subvisible particles, mainly, protein aggregates, in biopharmaceuticals have potential to elicit immune responses and could possess the immunogenicity. Owing to recent development of analytical methods, subvisible particles and protein aggregates ranging from nanometer to micron range can be now properly monitored. Meanwhile, therapeutic proteins including antibody drug could be experienced various types of stresses such as pH change, temperature raising, agitation, and shaking, which results in protein aggregation. In addition, silicone oil lubricated onto inner side of prefilled syringe is known to promote protein aggregation during agitation. In this talk, I’ll introduce possible root causes of protein aggregation and approach to reduce the aggregation in biopharmaceuticals.
Additional Info
Keywords: Please select up to 4 keywords ONLY:
Biopharmaceutical,Particle Size and Distribution,Particle Characterization,Surface Analysis
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