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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The Pharmaceutical Sciences, Manufacturing & Marketplace Report
Cynthia Challener, PhD
Editor
The Pharmaceutical Sciences, Manufacturing & Marketplace Report
