Ionimed in the Biotech Industry
Monitoring
of production processes in the biotech industry at present relies predominantly
on off-line sampling and direct analysis techniques. Our goal is
to provide a tool to improve this procedure by enabling online production
monitoring. This type of direct monitoring technique is the part of process analytical technology (PAT) initiative
currently being recommended by the US Food and
Drugs Administration (FDA) to improve quality, safety and efficiency in
drug manufacturing processes. Using PTR-MS we can measure volatile organic
compounds (VOCs) in the headspace air of a fermentor. These VOCs arise as a
result of microbiological activity during a fermentation process and provide an
indication of the current status and development of a production batch.
Our
expertise in the field of biotech research has been furthered by our inclusion
in the Austrian Centre of Biopharmaceutical Technology
(ACBT) , which we joined in July 2006. The main
objective of ACBT is "to achieve a
significant improvement in efficiency of biopharmaceutical process development ...
to provide widely optimised manufacturing processes for clinical trials and
mass production of biopharmaceuticals".
Our
work in ACBT includes collaborations with
academic as well as industry partners.
Within the framework of this competence centre we are using PTR-MS as a PAT tool to monitor and identify VOCs produced
during fermentations, with the ultimate aim to enable online process monitoring
and control.
Below
are two examples of fermentation processes that have been monitored with PTR-MS.
The different compounds show varying time evolutions throughout the processes,
which can be used to monitor the status of the fermentation.
It is envisioned that online monitoring with PTR-MS in
future will be an essential tool for optimisation of pharmaceuticals
production, helping to provide cost-effective development and manufacture of
new and already established medications and other pharmaceutical products.
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