Optimal has announced an enhanced working relationship with CAMO Software, which has resulted in further integration of the suppliers’ software products, offering faster drug development within a process analytical technology (PAT) framework. The respective software products are designed to deliver a simplified route to increasing production efficiency and accuracy in complex, data heavy process applications — as typified in commercial pharmaceutical manufacturing.
SynTQ from Optimal and The Unscrambler X from CAMO Software have both been developed independently but very much in the same vein. Having worked together on several projects, the products can now be fully integrated into an R&D or production environment. The result for end-users is a powerful model development, data management and production management solution that easily transfers from the laboratory to the production floor.
As manufacturing processes have evolved with the introduction of smart sensors, new testing procedures and data analysis techniques, there has been a huge increase in the amount of data being generated throughout the production cycle. In turn, the requirement to manage this data in a more efficient way has led to the adoption of increasingly powerful software products.
The design, development and test process is also becoming far more integrated into manufacturing so it is essential that the software packages also become more integrated in order to simplify use for the operator and reveal previously hidden information. This is the core benefit of the closer CAMO and Optimal cooperation, as both multivariate analysis and PAT data management software tools are vital components of a successful and compliant PAT implementation.
Moving away from a batch orientated production regime that has to be halted for quality checks to be made and towards a more continuous in-process solution requires powerful software, especially when regulatory compliance demands strict quality standards, data storage tracking and traceability.
A key mechanism in achieving this transition is the implementation of PAT. Part of a PAT process necessitates definition of the product’s critical quality attributes (CQAs). By measuring and controlling the process to optimise these CQAs, the manufacturer can produce a finished product of consistent and enhanced quality, while also reducing costs and waste.
In order to measure these CQAs in real-time, two software components are required — a PAT Data Manager such as synTQ from Optimal and a multivariate data analysis package such as The Unscrambler X from CAMO. synTQ is used to configure, run in real-time and coordinate all the spectral instruments demanded by the process. It also stores all the gathered data for regulatory purposes and passes the data on to The Unscrambler X for multivariate model building.
When the models are built, users can then run them in real-time within the synTQ environment combined with CAMO’s Process Pulse software or analytical engines. Users can then improve their process understanding by carrying out experiments where input parameters are varied and the resulting changes in CQAs are predicted in real time. Armed with process understanding and using the facilities in both packages, users can then develop and run control models using synTQ, ultimately enabling closed loop feedback and feed-forward control.
By introducing a PAT data management system such as synTQ and combining it with multivariate software from CAMO, manufacturers are able to reduce the overall cost of production, improve the quality of the final product and customer confidence in that product. All of this can be achieved while also meeting FDA and other regulatory guidelines.