Pharma industry in paradigm

Pharma industry in paradigm shift confirmed at conference

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.

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 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 Lilly, 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.

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