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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