In response to these trends, the new synTQ website www.synTQ.com provides all interested parties from system integrators to end users with a comprehensive public knowledge base for both synTQ and PAT. It also provides a gateway to the synTQ user site, MyPortal.synTQ.com for further detailed information and, plus the synTQ Assured product support portal for dedicated 24/7/365 support for synTQ Assured clients.
The public access areas of the site provide valuable insight into the practical application of PAT principles and methods. PAT and synTQ can be applied to all areas of drug manufacture from R&D and the laboratories through pilot plants to full manufacturing facilities. Consequently, the technology is making huge changes to how many pharmaceuticals are produced. Many in the industry believe it represents a paradigm shift within an industry that has been relatively slow to implement changes in their development, manufacturing and approval processes.
Optimal’s synTQ has steadily been gaining traction as the preferred choice of PAT Knowledge Management software for many of the global majors – designating synTQ as a key component in their PAT implementation strategy. This trend was further highlighted at the popular PAT conference IFPAC and subsequently at Optimal’s synTQ User Group meeting, where it became clear that more businesses are committed to implementing and reaping the benefits of this technology.
PAT has long been a topic of theoretical debate – however with some of the largest pharmaceutical companies now investing millions in new PAT enabled plants and labs, theory is rapidly becoming reality.
Visitors to both events would have been treated to a number of talks on the implementation of PAT and how it is currently affecting real businesses. Companies that presented included, Vertex Pharmaceuticals, Bristol-Myers Squibb, Sun Pharma, Lilly and the Janssen division of Johnson & Johnson. With many regulators actively encouraging PAT together with an ever growing implementation knowledge base and a number of case studies, it seems PAT is snowballing within big pharma.
The benefits of PAT are widespread in that it delivers much more efficient batch manufacturing, it facilitates the use of continuous manufacturing and it enables the dream of Real time Release (RtR). It is applicable to small and large molecule products, to laboratories and R&D, to primary and secondary manufacturing. Development and production times together with raw material usage during development are slashed, these aspects typically delivering a very fast ROI.
The use of synTQ facilitates PAT based real time monitoring and control, where a product’s very specific Critical Quality Attributes (CQAs) can be predicted non-destructively in real time using multivariate models. In turn, this knowledge enables the control of the process to optimise the product’s quality and reduce if not eliminate scrap and rework.
Vast amounts of quality data are gathered, and this enables the significant reduction and potential elimination of In-Process Checks (IPCs), and enables the realisation of Real time Release. Thus with PAT and synTQ specifically, products can be brought to market faster plus be manufactured faster, to a higher quality and to a lower cost.
The synTQ web site provides common user data for all aspects of the synTQ software, plus the MyPortal and synTQ Assured login areas for the ticketed 24/7/365 support area. The authorised users for this area can enter and track any issues, search FAQs, download software applicable to the licences that they have purchased, plus all related upgrades and patches – including the latest major releases whilst their support programme is in place. A vast wealth of technical knowledge is also accessible – incorporating knowledge-based articles from experts; details associated with a client’s specific installation, how-to and troubleshooting articles.
The new synTQ website and synTQ Assured portal are therefore important pillars in the growing infrastructure around PAT – dedicated to serving the industry with vital knowledge to make the most of a customer’s synTQ system. As with any new technology, guidance and knowledge are vital to its transmission within the industry if a paradigm shift is to be truly achieved. With the launch of the synTQ website and support portal, Optimal is dedicated to not only providing the tools – but also a service and knowledge centre so others can gain from this technology.
The public synTQ website is located at: www.synTQ.com and prospective synTQ Assured Customers can contact Optimal through the website, by email enquiries@optimal-ltd.co.uk or by phone +44 (0) 1454 333222 to request a quotation for synTQ Assured support and access to the dedicated support portals.
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