Automation
Laboratory Instrumentation

Differentiation and Characterisation of Subvisible Particulates in Therapeutic Protein Products

Published 20 October 2014 | By Malvern Panalytical

The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life.

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Differentiation and Characterisation of Subvisible Particulates in Therapeutic Protein Products