Automated quality assurance shifts pharma manufacturing toward continuous production
28 November 2019
The majority of the top ten global pharmaceutical companies are now starting to work with a new type of control system for complex processes.
It allows for ‘live’ quality assurance & control over continuous production, which is a huge departure for the traditionally batch-manufacture orientated industry. The results in terms of productivity increases however are startling…
Over half of the top ten global pharmaceutical companies are now using or evaluating the synTQ process analytical technology (PAT) based production and development software platform from Optimal – in combination with high-end sensors and machine control. The synTQ suite has the capacity to reduce lead times in drug development and production, as well as reduce costs, improve product quality attributes and connect the supply chain.
Use of the latest Process Analytical Technology (PAT) software is creating a paradigm shift in pharmaceutical production, one that could come to represent the largest shift in market dynamics in the last few decades. For patients, it promises to bring drugs to market faster in the future; while for manufacturers, it offers increased productivity from the same manufacturing footprint and reduced production costs on compounds that were traditionally more time consuming to manufacture.
From a control automation point of view product related data is being produced by sensor technology such as Near-infrared (NIR) spectroscopy and collected in real-time. The data is then processed by a knowledge management software layer which uses multivariate analysis to compare live data with established historical patterns and predictive models to provide quality predictions. The control software then exerts ‘live’ control over various aspects of the process machinery, usually via a PLC or DCS. The result is the fine-tuning of a complex process to ensure key quality attributes stay within very tight tolerances.
When applied holistically you will have end to end quality assurance for the whole production process, and so the potential is for the end product to be approved for Real time Release (RtR), this avoiding the time and costs associated with final release testing. As an option, Edge computing can also be used to streamline data handling, with the real time processing being executed at or close to, lineside, with the large volumes of data being stored in the cloud.
Blue-Chip pharma companies all share in PAT implementation experience
Speaking at a recent synTQ user conference in Maryland USA – representatives from leading Blue-Chip pharma companies shared their PAT implementation and execution experiences using the synTQ platform with other industry professionals and academics. Furthermore, the event provided an opportunity for Optimal to gather essential development feedback, information which is already influencing the current iteration of the software: synTQ V5.
Born out of a need to find a workable holistic production methodology that complied with guidelines from the FDA and other independent regulatory bodies – synTQ utilises a PAT working methodology to enable continuous manufacturing by influencing production from the initial design of experiments stage. Knowledge gained is stored within the system in a regulatory compliant way and can be passed from development and trial systems to full production processes. This knowledge is invaluable; and has the potential to greatly reduce or eliminate scale up time, this time saving during the development phase having the same effect as an extension in patent life.
Information on quality attributes and process parameters is acquired and interpreted via univariate and multivariate methods in real time, the results of which then actively influence production processes to achieve a fully compliant finished product with consistently high quality. As a result of this quality assurance, real-time release for pharmaceutical products is now attainable.
Managing the change from batch production to continuous
Driven by the successful implementation of synTQ and the wide-ranging benefits of a proven PAT framework, changing over from batch production of pharmaceuticals to continuous production, combined with real-time release of approved product into the supply chain – direct from production, is re-shaping the landscape of pharmaceutical production. Constraints of the past such as mid-process and post production batch testing are now being rendered redundant as PAT frameworks continue to develop further, redefining what is possible for manufacturers of pharmaceuticals.
The shockwaves from the advent of continuous PAT production for OSD products have rippled through to API and Biotech production, where the activity level is increasing dramatically. Where used in OSD, the implementation of synTQ with continuous manufacturing has already reduced production time for some high value drugs from weeks to hours…literally. Benefits are also being delivered to all parts of the life science sector plus to chemical and food & beverage industries – where similar benefits can be reaped with a potentially very quick Return on Investment.
What will the effect of PAT implementation be for the end user?
As with any paradigm shift in technology, the full effect of the changes will take time to filter through to every corner of the market. However, sourcing medication from early adopters of the technology offers increased availability, expedited transmission of developments to the market and potentially reduced costs for certain medications that have typically been more challenging, time consuming or costly to produce.
The uptake of the technology by global major pharmaceutical manufacturers will continue to grow, simply because of the unique offering of PAT and synTQ where the technology can reduce development and manufacturing costs whilst still delivering increased product quality and speed of production.
To find out more about synTQ or the next synTQ user conference, contact Optimal directly at synTQ.com
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