Lonza Group Ltd. and CAMO Software AS have entered into an agreement to deliver a PAT software solution to the Lonza Visp site
CAMO Software, leaders in multivariate data analysis software, and Lonza Group, a leading supplier to the pharma, biotech and specialty ingredients markets, have entered into an agreement where CAMO Software will deliver a PAT software solution for collecting, handling, storing, monitoring and modeling of PAT data. The solution will complement Lonza’s existing operations and assure compliance with regulatory PAT and QbD initiatives.
The solution consists of a combination of CAMO’s flagship software packages The Unscrambler® X and The Unscrambler® X Process Pulse, and includes adaptations to meet Lonza’s specific operational requirements.
The solution connects directly to data sources in the Lonza production lines and records and stores the data in secure databases. During data recording, multivariate models can be run to track process performance and quality parameters.
This tracking enables real-time quality control. The recorded data is also available for future data analysis, troubleshooting and product traceability.
The solution will be integrated with existing production systems at Lonza. The integrated solution will offer greater flexibility with minimal system duplication.
Delivery of the solution will be completed in phases, with the first delivery scheduled for Q4 2014.
Tobias Merz, PAT Lead at Lonza Group, says, “It is a great opportunity to develop a software solution tailored to our needs together with CAMO. As a contract manufacturer, it is important to be flexible and open to new technologies. The implementation of a PAT data management solution allows us to build up process knowledge from the beginning of a new process development and close the gap between R&D and production.”
Geir Rune Flaaten, Business Development Director, Europe at CAMO Software, adds, “This is a great initiative by Lonza and will move the company to the front line of their industry with respect to PAT. It is also in line with the PAT and QbD visions put forward by the regulators in the life sciences industry. The solution is also very much in line with CAMO’s expectations for future PAT requirements”.
The Unscrambler® X software offers advanced multivariate methods, data visualization tools and the ability to cut through large data sets. It is used in the pharmaceutical, food & beverage, chemical, energy, mining & metals, paper and agriculture sectors.
The Unscrambler® X Process Pulse offers early fault detection and immediate identification of out-of-limit variables for real-time process control, giving users the possibility to remedy potential failures before they occur. The software includes advanced quality predictions and drilldown plots to investigate the variables contributing to deviations.