Cross-Pharma Collaboration for the Development of a Simulation Tool for the Model-Based Digital Design of Pharmaceutical Crystallization Processes (CrySiV)

Autor: Nandkishor K. Nere, Daniel Patience, Aaron S. Cote, Yiqing Claire Liu, Moussa Boukerche, Iben Østergaard, Daniel Pohlman, Eric B. Sirota, Daniel A. Green, Kushal Sinha, Justin L. Quon, Ryan Ellis, Jaron Mackey, Daniel J. Jarmer, Botond Szilagyi, Michael A. Lovette, Huayu Li, Ayse Eren, Zoltan K. Nagy, Wei-Lee Wu, Rahn McKeown, Lorenzo Codan, Erwin Irdam, Shivani Kshirsagar, Kevin P. Girard, Megan Ketchum, Yihui Yang, Haiyan Qu, Christopher S. Polster, Jie Chen, Venkata Ramana Reddy, Emoke Szilagyi, Samir A. Kulkarni, Anna Jawor-Baczynska, Akshay Korde, Laurie Mlinar, Bing-Shiou Yang, Jochen Schoell, Christopher L. Burcham, Jeremy M. Merritt, Simon N. Black

Publikováno v: Szilagyi, B, Wu, W-L, Eren, A, Mackey, J, Kshirsagar, S, Szilagyi, E, Østergaard, I, Qu, H, Sinha, K, Mlinar, L, Pohlman, D, Chen, J, Nere, N, Boukerche, M, Korde, A, Ellis, R, Lovette, M, Black, S, Jawor-Baczynska, A, Li, H, Yang, B-S, Irdam, E, Patience, D, McKeown, R, Ketchum, M, Green, D A, Reddy, V R, Polster, C, Burcham, C, Jarmer, D, Merritt, J M, Cote, A, Sirota, E, Codan, L, Schoell, J, Liu, Y C, Girard, K P, Kulkarni, S A, Yang, Y, Quon, J L & Nagy, Z K 2021, ' Cross-pharma collaboration for the development of a simulation tool for the model-based digital design of pharmaceutical crystallization processes (CrySiV) ', Crystal Growth & Design, vol. 21, no. 11, pp. 6448-6464 . https://doi.org/10.1021/acs.cgd.1c00904

Precompetitive collaborations on new enabling technologies for research and development are becoming popular among pharmaceutical companies. The Enabling Technologies Consortium (ETC), a precompetitive collaboration of leading innovative pharmaceutic

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c526c98437c173db7499a157af9f261f
https://doi.org/10.1021/acs.cgd.1c00904

Small-Volume Continuous Manufacturing of Merestinib. Part 1. Process Development and Demonstration

Autor: Mindy B. Forst, Edward W. Conder, Brandon J. Reizman, Timothy M. Braden, Justin L. Burt, Christopher S. Polster, Molly Hess, Kevin P. Cole, Bradley M. Campbell, David Mitchell, Richard F. Cope, Michael E. Laurila, Moussa Boukerche, Martin D. Johnson, Aurpon W. Mitra, Michael R. Heller, Richard D. Miller, Jennifer McClary Groh, Joseph L. Phillips, John R. Howell, Todd D. Maloney

Publikováno v: Organic Process Research & Development. 23:858-869

Development of a small volume continuous process that used a combination of batch and flow unit operations to manufacture the small molecule oncolytic candidate merestinib is described. Continuous processing was enabled following the identification a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::aaef0d8d2753aa1c2899452eb9cc8bfd
https://doi.org/10.1021/acs.oprd.8b00441

Digital Design and Operation of Continuous Crystallization Processes via Mechanistic Modelling Tools

Autor: Sean K. Bermingham, Christopher L. Burcham, Furqan Tahir, Niall Mitchell, John Mack, Christopher S. Polster

Publikováno v: The Handbook of Continuous Crystallization ISBN: 9781788012140

This chapter will outline the application of digital design tools, specifically mechanistic models in the pharmaceutical industry, to enable more efficient development, design and control of API crystallization processes. Calibrated mechanistic model

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f580bbd25519a60d1be3fa04a670ccc6
https://doi.org/10.1039/9781788013581-00577

Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions

Autor: Neil J. Kallman, Bradley M. Campbell, David Mitchell, Declan Hurley, Jim Cashman, Thomas M. Koenig, Michael R. Heller, Richard D. Miller, Christopher S. Polster, Olivia Gowran, Scott A. May, Kenneth Desmond, Paul E. Sheehan, Robert Moylan, Paul Desmond, Martin D. Johnson, David P. Myers, Jennifer McClary Groh, Joseph L. Phillips, William D. Diseroad, John R. Howell, Timothy D. White, Christopher L. Burcham, Myers Steven Scott, Kevin P. Cole, Richard D. Spencer

Publikováno v: Science. 356:1144-1150

Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::286c7186d5b23cf038f82ff1012530e4
https://doi.org/10.1126/science.aan0745

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