Seeking Continuous Success

Continuous manufacturing is attracting growing attention as pharmaceutical manufacturers and industry regulators come to realize the potential benefits with respect to improved quality consistency, increased efficiency, and lower costs. Many small-molecule advanced pharmaceutical ingredients require crystallization to achieve the necessary levels and/or the most appropriate form for drug formulation. Therefore, the development of continuous crystallization processes is necessary if fully continuous manufacture of such products is to be achieved.

Several pharmaceutical companies, including GlaxoSmithKline (GSK), Novartis, and Astrazeneca, have chosen to support the Center for Continuous Manufacturing and Crystallization (CMAC) to accelerate the development of practical, commercial-scale techniques for continuous crystallization.

CMAC was established in 2011 with support from these drug companies, equipment and instrumentation manufacturers, engineering design firms, and fine chemical producers. The physical hub is at the University of Strathclyde (Glasgow), with Glasgow, Heriot-Watt, Edinburgh, Cambridge, Loughborough, and Bath Universities rounding out the multidisciplinary academic team. The center has raised nearly $100 million in 2 years, initiated several research projects, implemented a doctoral training program across the network (45 PhD students), and is starting a Maters program. The researchers are targeting ten key areas, including the investigation of appropriate raw materials and synthetic methods, continuous nucleation, growth and habit control, mixing, flow and transport, powder production and processing, and particle properties and performance.

Initial projects have focused on the use of existing equipment, such as a mixed suspension mixer product removal (MSMPR) crystallizer, continuous stirred tank reactors (CSTRs), and meso-scale and full-scale continuous oscillatory baffled crystallizers (COBCs). Others are developing new technologies for which patents have been filed, including a device for inducing nucleation (Heriot-Watt University), customized nucleation units for seed suspension (University of Strathclyde), and a moving fluid oscillatory baffled crystallizer and new flow crystallization technology for multicomponent products (University of Bath).

Do you think this type of organization is the way of the future with respect to technology advancement? Can companies achieve real advances in technology just with their own staff and knowledge base anymore?  How will the economic advantages play out if much of new technology is developed by cooperative industry-funded groups?

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Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report