Ensuring a Consistent, High-Quality Biologic Drug Process Development 

The development process for a biologic is generally divided into cell line development, upstream and downstream development, manufacturing, and formulation development, where each development process holds its own purpose along a biologic’s journey to commercialization.   In this article we are going to answer some questions related with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development...
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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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