INDUSTRY FOCUS CHEMICALS & PHARMACEUTICALS
PAT PRODUCTION TECHNOLOGY CAN REDUCE DRUG DEVELOPMENT TIMES
Attendees at this year’s user conference for market-leading PAT knowledge management software, synTQ expressed a clear intention to continue the application and roll-out of PAT (Process Analytical Technology). This affirms that users are now working in line with the FDA’s guidance on PAT and reaping the benefits of this technology which has promised so much for so long for the whole drug development and manufacturing lifecycle
P
rocess Analytical Technology when correctly applied can reduce drug
development and production times whilst simultaneously improving quality and reducing cost. This applies equally to batch and discrete manufacturing techniques, but also puts the operating framework in place to realise continuous manufacturing and real-time release, which will amplify the already significant improvements that are now possible. The synTQ User Group (SUG)
conference was held in Washington DC earlier this year, directly following the global PAT conference IFPAC. synTQ users, developers and application experts joined with technical support operatives from synTQ’s software creator, Optimal to discuss the use of what has now become a market standard solution for PAT implementations, including continuous drug production and real- time release via a PAT framework. Conference attendees enjoyed presentations on ‘real-time automatic advanced control of continuous pharmaceutical tablet manufacture’ from Dr Ravendra Singh from the Department of Chemical and Biochemical Engineering, Rutgers University, USA, plus, user experience case studies from Vertex Pharmaceuticals, Bristol-Myers Squibb, Sun Pharma and the Janssen division of Johnson & Johnson. Martin Gadsby, director at Optimal and one of the speakers at the event commented on how industry attitudes have crystallised and action is now being taken: “There is no doubt that Process Analytical Technology (PAT) is the key emergent process technology in the pharmaceutical drug production industry today. The savings in time-to-market for development and the speed of production, once the operational model is transferred, are breathtaking. As an
14 JUNE 2015 | AUTOMATION
Process Analytical Technology (PAT) is the key emergent process technology in the pharmaceutical drug production industry today, according to Martin Gadsby, director at Optimal Automation
example we have seen production processes that previously took weeks using batch production methods reduced to a matter of minutes. “Enthusiasm for a PAT enabled
production technique has been there in the market for a decade, the difference now, however, is that a number of the major global pharma companies and generics manufacturers have bought into synTQ and are seeing the potential turn into a reality. The user conference, combined with rising sales of course, is a litmus test for us on where the industry is at in terms of PAT; the range of questions we were asked and the enthusiasm for technical development to provide new tools and feature updates showed this year that the industry is indeed changing as adoption of this way of working takes-off.”
REALISING A PAT ENABLED PROJECT To be able to use all the data streaming from lab and production equipment sensors and instruments, in real-time, to develop a PAT based production process for a new drug, or an existing one, means that there is a huge amount of data to manage. There are many disparate instruments and sensors to configure and co-ordinate, one or more MVA models to run and maybe control algorithms to run, this being in real time and not after the fact. These are the typical requirements of a PAT based system; however, you need an effective data and knowledge manger such as synTQ in order to achieve it. One that can keep-up with the myriad of data sources and process the vast amount of data in real time, load it into multiple complex multivariate models, gather and act on the calculated Critical Quality Attributes and make changes and adjustments to the process on the fly, in real-time. Additionally it has to convert the data to knowledge to facilitate the process understanding, plus
record, collate and report on all the information in a way that is compliant with regulatory body guidelines in order to achieve real-time release. By effectively allowing all the skilled key
players in a PAT implementation to work together using the same operational software platform, the application of a PAT enabled development and production process using an easy to configure, graphically based data management solution such as synTQ is proving irresistible to the industry, especially now that many of the significant market players have adopted it as their PAT Knowledge Manager of choice. The good news for consumers and patients is that medicines in the future may well reach the market faster and represent a more consistent and even higher quality standard than is being achieved right now. Furthermore the decreased cost of development and manufacture may filter down to reduced costs, creating the uncommon scenario where you can deliver a product faster, to a higher quality and at a lower cost.
ABOUT SYNTQ The synTQ PAT Knowledge Management Software Suite has been adopted by many of the leading global drug producers to effectively implement PAT, providing universal hardware and software system integration via true real-time data recording and data management from the development lab, through to full-scale production. Being easy to configure and capable of true real time performance it is well suited to all development and manufacturing scenarios, and has proved itself to be an effective PAT engine in a multi analyser continuous process and facilitate real time release.
Optimal Industrial Automation
www.optimal-ltd.co.uk T: 01454 333222
Enter 206 /AUTOMATION
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