8 January 2020
There is a future for flow within the Life Sciences – a new industrial sector for the TÜV SÜD National Engineering Laboratory - according to a report written by its newly-appointed Head of Life Sciences,
Dr Tracy Brown, for the Institute of Measurement and Control’s Flow Measurement Special Interest Group.
Following a period of intensive horizon scanning across the sector, work is now underway to develop tangible project proposals with potential collaborators from industry, innovation centres, academia and
the NHS in the primary areas experiencing flow metrology challenges; namely, continuous pharmaceutical manufacturing and non-invasive medical imaging.
Continuous manufacturing (CM) has the potential to transform medicine production over the next decade enabling a new era of scalable, flexible manufacture of novel, complex drugs. In addition to knowledge of production technology, process engineering and the regulatory landscape, sound flow measurement science and standards development will play an important part in bringing this nascent manufacturing approach to life within the pharmaceutical sector. The fiscal and societal impacts of CM are significant; enhanced profitability for pharmaceutical companies and the delivery of more effective medicines to patients faster.
There is a need to investigate new metrological methods to describe powder flow / behaviour during the stages of oral solid dosage (OSD) form (tablets, capsules, dry powder inhalers) manufacture from raw material discharge from bins, feeding, mixing, granulation, milling, filling, compression and capsule filling. A key requirement of such measurement is that it must subject the medicinal material as closely as possible to the conditions it experiences within a particular process, i.e. stresses and strain rates. Continuous wet granulation and continuous direct compression present initial processes targets as these are the focus of current R&D activity within the pharmaceutical industry. Deeper understanding of powder surfaces, particle structures/properties and bulk flow behaviour is necessary to predict and optimise the manufacturability, stability and storage of novel and complex oral solid formulations. Development of corresponding new traceable metrological methods and the calibration and validation of process analytical technologies for in-line, real-time quality control will furnish TÜV SÜD National Engineering Laboratory with unique capability that can be applied in a step-wise progression across the spectrum of OSD unit operations. We are actively engaging with pharmaceutical companies and associated innovation centres to identify collaboration opportunities to help tackle the industry’s flow metrology challenges.
Exploitation of the significant technological developments in blood flow and haemodynamic measurement offered by MRI (magnetic resonance imaging) and ultrasound imaging modalities show promise in balancing clinicians’ current reliance upon subjective, qualitative scan analysis in favour of quantitative evaluation. Dr Brown recently presented an introduction to TÜV SÜD National Engineering Laboratory and the UK’s Flow Measurement Facilities at an inaugural 4D Flow MRI Workshop hosted by SINAPSE at the Imaging Centre of Excellence (ICE), part of the University of Glasgow and housed at the Queen Elizabeth University Hospital. The workshop brought together up to 30 experts from industry, NHS and academia with an interest in flow-related imaging research to visit the world-leading MRI research department and its state-of-the-art facilities; discuss current 4D flow MRI projects and the potential applications of this emerging imaging technology and provide a platform for interaction on future 4D flow projects and potential collaboration. Follow-on discussions to develop project concepts is planned for early 2020
Continuing the theme of medical imaging, we are seeking to expand into the area of standards development for the flow phantoms used widely to calibrate ultrasound scanners and as investigative tools to test new ultrasound techniques. Building reproducible quantitative flow metrology capability, traceable to relevant standards, into evolving medical imaging technologies will bring the rigour necessary to expedite their clinical translation to realise improved diagnostic confidence and patient outcomes, earlier intervention and more personalised therapeutic decisions related to cardiovascular disease.
For the full report, click here.
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