Process Analytical Technology when correctly applied can revolutionise drug production by reducing development and manufacturing 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 from 29th – 30th January 2015 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 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”.
The IFPAC exhibition and conference that directly preceded our event, which we were also involved with, served to underline the fact that the pharmaceutical industry is making the step change from the stricture of slow, inefficient and cumbersome batch production techniques, to fully integrated regulatory compliant PAT based production including continuous technology.
We have exhibited at IFPAC for over 10 years and are used to the discussions surrounding theoretical PAT implementations. However this year things were different in that the discussions were in relation to real projects where it was recognised that data and knowledge management needed resolution, these being key challenges to successfully applying the technique.
This for us clearly demonstrates that if not a paradigm shift; then there is certainly a substantial change in the way that drugs are being developed and produced. PAT enabled batch and continuous production isn’t the end of the changes that are happening though, for many, real-time release of drugs is the end goal, this having a huge additional impact on the industry’.
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 & 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 drug 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.
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