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Enabling precision manufacturing of active pharmaceutical ingredients : workflow for seeded cooling continuous crystallisation

Brown, Cameron J. and McGlone, Thomas and Yerdelen, Stephanie and Srirambhatla, Vijay and Mabbott, Fraser and Gurung, Rajesh and Briuglia, Maria L. and Ahmed, Bilal and Polyzois, Hector and McGinty, John and Perciballi, Francesca and Fysikopoulos, Dimitris and Macfhionnghaile, Pól and Siddique, Humera and Raval, Vishal and Harrington, Tomás S. and Vassileiou, Antony and Robertson, Murray and Prasad, Elke and Johnston, Andrea and Johnston, Blair and Nordon, Alison and Srai, Jagjit and Halbert, Gavin and Ter Horst, Joop H. and Price, Chris J. and Rielly, Chris D. and Sefcik, Jan and Florence, Alastair J. (2018) Enabling precision manufacturing of active pharmaceutical ingredients : workflow for seeded cooling continuous crystallisation. Molecular Systems Design & Engineering, 2018 (3). pp. 518-549. ISSN 2058-9689

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    Abstract

    Continuous manufacturing is widely used for the production of commodity products. Currently, it is attracting increasing interest from pharmaceutical industry and regulatory agencies as a means to provide a consistent supply of medicines. Crystallisation is a key operation in the isolation of the majority of pharmaceuticals and has been demonstrated in a continuous manner on a number of compounds using a range of processing technologies and scales. Whilst basic design principles for crystallisations and continuous processes are known, applying these in the context of rapid pharmaceutical process development with the associated constraints of speed to market and limited material availability is challenging. A systematic approach for continuous crystallisation process design is required to avoid the risk that decisions made on one aspect of the process conspire to make a later development step or steps, either for crystallisation or another unit operation, more difficult. In response to this industry challenge, an innovative system-wide approach to decision making has been developed to support rapid, systematic, and efficient continuous seeded cooling crystallisation process design. For continuous crystallisation, the goal is to develop and operate a robust, consistent process with tight control of particle attributes. Here, an innovative systems-based workflow is presented that addresses this challenge. The aim, methodology, key decisions and output at each at stage are defined and a case study is presented demonstrating the successful application of the workflow for the rapid design of processes to produce kilo quantities of product with distinct, specified attributes suited to the pharmaceutical development environment. This work concludes with a vision for future applications of workflows in continuous manufacturing development to achieve rapid performance based design of pharmaceuticals.