Website (1-3 of 3)

1. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

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   Website | 16 Sep 2024 | Contributor(s):: Richard Steiner

   In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process...

2. A Focused and Flexible Analytical Strategy is Key to Unlocking the Benefits of Continuous Manufacturing

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   Website | 11 Apr 2024 | Contributor(s):: Bikash Chatterjee

   Continuous manufacturing processes promise shorter manufacturing cycle times without the need for intermediate storage, sampling testing and release of intermediate process steps, and shorter product release times through the intelligent application of in-line and at-line testing strategies....

3. The Changing Face of Process Development & Chemical Manufacturing - A View from the Regulators on Continuous Manufacturing

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   Website | 09 Jun 2023 | Contributor(s):: Wiles, Charolotte

   Industry wide there is a drive for resource efficiency and flexibility, to adapt quickly in what is increasingly becoming a volatile, changing marketplace. As the ‘patent cliff’ looms for many high-volume API’s, there is also a shift away from blockbusters towards lower volume, higher potency...