Characterization and Validation for Biologics

Monoclonal antibodies and next-generation therapeutics need a more complex manufacturing process than a simple enzyme. For those molecules you need to assure their quality attributes and safety profile. In this article, we are going to explain how this validation process is done.    Understanding Process Risks  Even during the early drug discovery process, there are valuable opportunities to simplify the path to commercialization.  At this stage, multiple candidate molecules may be screene...
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