One of the cardinal objectives of the 21st Century Cures Act is the acceleration of pharmaceutical product development through innovation and modernization.  While there has been some progress in the adoption of modern PAT and emerging technology such as continuous manufacturing in the manufacturing of solid oral dosage forms, there has been little to no innovation in freeze-drying of biopharmaceuticals. This presentation will highlight research done by the Office of Testing of Research aimed at advancing the implementation of advanced spectroscopy as PAT tools and emerging technology in pharmaceutical freeze-drying.  <br/>

Advancing innovation and the adoption of emerging technology in pharmaceutical freeze-drying through laboratory research at FDA’s office of testing and research

2019 Fall National Meeting

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