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.
About CAMO Software AS
Founded in 1984, CAMO Software is a recognized leader in Multivariate Data Analysis and Design of Experiments software. Our solutions are used by more than 25,000 people in 3,000 organizations to analyze large data sets, improve process or equipment control and build better predictive models. We help our clients make better decisions through deeper insights from their data, reduce R&D costs, improve production processes and product quality. For more information, visit www.camo.com.
About Lonza Group Ltd.
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that supportsafer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 10,000 employees worldwide. The company generated sales of about CHF 3.6 billion in 2013 and is organized into two market-focused segments: Pharma & Biotech and Specialty Ingredients. Lonza’s stock is publicly traded on the Swiss and the Singapore stock exchanges. For more information, visit www.lonza.com.