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Tags: GMP

Peer-reviewed journal (1-3 of 3)

  1. Regulatory and Quality Considerations for Continuous Manufacturing

    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

    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

    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...