Advantages of PAT operating frameworks highlighted at Interphex Japan
Optimal Industrial Automation and its synTQ V5 process analytical technology (PAT) based production and development platform proved extremely popular at Interphex Japan. A regular at Interphex events, Optimal’s regional Application Partner – Quality Design Co Ltd., of Osaka, Japan took the opportunity to demonstrate the tangible benefits that PAT offers to manufacturers of pharmaceuticals with a number of other exhibitors also highlighting the synTQ platform during the event.
The exhibition booth was hosted by Quality Design Co Ltd., the leading PAT partner in Japan, where they also exhibited complimentary PAT products. Also joining the team was Brad Swarbrick from Quality by Design Consultancy of Australia, Brad being a key speaker at the event with his presentation “Current QbD Data Handling and Analysis Trends for Continuous and Biologicals Production” being very well received. With momentum around the adoption of PAT snowballing, interest in the synTQ platform is increasing correspondingly. synTQ for example has seen adoption by over half of the world’s largest global pharmaceutical manufacturers. The benefits of expedited production schedules and the realisation of continuous manufacture and real-time release are proving too much for manufacturers to ignore.
Interphex serves as a perfect forum for Optimal to touch base with the market, liaising with its users to share ideas relating to the future development direction of the software. This year, the event attracted over 37,000 visitors, incorporating pharmaceutical and biotech professionals from around the world. PAT software frameworks such as synTQ V5 fit the event philosophy of displaying state-of-the-art solutions to develop and manufacture quality product in a cost effective manner.
Existing customers are using synTQ to predict product Critical Quality Attributes during a production process in a non-destructive manner, utilising multivariate and univariate instrument technologies, then interpreting gathered results in real time. This information is used to predict product quality throughout the process, and then armed with this information synTQ is able to take active steps to control the process based on these quality attributes. This is very different to the traditional method of using process parameters to control the process, as these are likely to not have any direct bearing on product quality. Thus, product quality is assured by such a “Quality by Design” solution, and the traditional requirements for lengthy testing post production can be eliminated.
PAT platforms such as synTQ V5 offer an attractive combination of reduced development and manufacturing times, decreased costs and improved product quality and the consistency of quality. This holistic quality assurance offers the attainment of continuous manufacturing and real-time release for pharmaceuticals – a goal that is fuelling a paradigm shift towards PAT in the industry.
The event also served to highlight some new developments for synTQ V5 going forward, features which have been directly influenced by Optimal’s discussions with users. These include a new real time MSPC viewer and new Control Charts that are entirely configurable by users. The Control Charts not only detect when processes move out of control, but can also take appropriate corrective action. As ever, user experience is a focus for Optimal and the future of synTQ.
Martin Gadsby, Director at Optimal Industrial Automation, commented: “Interphex Japan was a highly successful event for us, giving us a perfect chance to meet with our partners and users. synTQ was featured by companies on stands and during presentations – so it was exciting for us to see the increased uptake of the package translate into greater exposure for PAT as a whole. It highlights the benefits of building capable software platforms while taking into account the specific requirements of users. PAT is here to stay!”