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Tags: critical material attributes (CMAs)

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  1. 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....

  2. Impact of Critical Material Attributes (CMAs)-Particle Shape on Miniature Pharmaceutical Unit Operations

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    Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Azad, Mohammad A., Capellades, Gerard Wang, Allison B. Klee, David M., Hammersmith, Gregory, Rapp, Kersten, Brancazio, David, Myerson, Allan S.

    The U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a CMA)...