Camo Software, an expert in multivariate data analysis software, and Lonza, a leading supplier to the pharma, biotech and speciality 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 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, 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".