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Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Summary: When biopharma companies choose a partner to develop and manufacture their biologic, they sometimes run into challenges associated with drug product process development. It’s critical that biopharma companies work with a partner that has the proven expertise to conduct drug product process development on their innovator or biosimilar drugs. In this Q&A, one Catalent Biologics expert shares his expertise with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development, and what to expect from the development and manufacturing partner during the drug product process development phase.

 

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