This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|September 3, 2020
Manufacturing Biopharmaceuticals from Start-up to Commercialization
Author(s)PDA
This ebooklet walks through the steps required to take a biologic/biopharmaceutical product forward to commercial manufacturing. It distinguishes between a drug and biologic, which is key to understanding the complex requirements for biologics development and manufacture.
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The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.