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|June 16, 2023
Regulatory Spotlight - Compendia Updates: USP <621> and USP <1220>
Author(s)Eurofins BioPharma Product Testing
Compendia publications are periodically updated in order to align with industry trends and harmonize with global regulatory practices. Staying abreast of these changes well before they are implemented, and being ready to adapt as necessary, is in the best interest of any bio/pharmaceutical testing laboratory. Eurofins BioPharma Product Testing has proactively adjusted its procedures, collaborating with stakeholders and providing feedback to ensure smooth integration and minimal impact on existing testing methods.
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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.