Resources (1-3 of 3)

1. Regulatory and Quality Considerations for Continuous Manufacturing

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   09 Jun 2023 | Contributor(s):: Allison, Gretchen, Cain, Yanxi Tan, Cooney, Charles, Garcia, Tom, Bizjak, Tara Gooen, Holte, Oyvind, Jagota, Nirdosh, Komas, Bekki, Korakianiti, Evdokia, Kourti, Dora, Madurawe, Rapti, Morefield, Elaine, Montgomery, Frank, Randolph, William, Robert, Jean-Louis, Rudd, Dave, Nasr, Moheb, Zezza, Diane

   This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including...

2. Recent Advances in Co-processed APIs and Proposals for Enabling Commercialization of These Transformative Technologies

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   09 Jun 2023 | Contributor(s):: Schenck, L, Erdemir, DGorka, LS, Merritt, JM, Marziano, I, Ho, R, Lee, M, Bullard, J, Boukerche, M, Ferguson, S, Florence, AJ, Khan, SA, Sun, CC

   Optimized physical properties (e.g., bulk, surface/interfacial, and mechanical properties) of active pharmaceutical ingredients (APIs) are key to the successful integration of drug substance and drug product manufacturing, robust drug product manufacturing operations, and ultimately to attaining...

3. Development and Scale-Up of a Continuous Aerobic Oxidative Chan-am Coupling

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   09 Jun 2023 | Contributor(s):: Brewer, AC, Hoffman, PCMartinelli, JR, Kobierski, ME, Mullane, N, Robbins, D

   Despite the benefits of high atom economy and low cost, aerobic oxidations have found limited use in the synthesis of active pharmaceutical ingredients (APIs) because of safety concerns and poor selectivity. In this report, the design, development, and scale-up of a continuous, high pressure...