PAT (Process Analytical Technology) is a tool within the QbD (Quality by Design) toolbox enabling real-time quality assurance. However the use of PAT is still not standard within the life sciences. The reasons may be many but typical explanations are that it is too time consuming, too costly, or there is simply no proof that it will benefit the operations. The premise for any PAT implementation is that it has to benefit the operations in an efficient and economically meaningful way.
The two fundamental requirements for successful PAT projects are relevant and cost effective tools in, addition to a justified business case. CAMO Software is working in this space to offer customers market leading software solutions for PAT applications.
The Unscrambler X is regarded as the best tool for analysis of historical PAT data with its wide selection of Chemometrics methods and intuitive user interface. CAMO also offers Process Pulse, which makes using Unscrambler models in online PAT applications easy. Process Pulse is scalable from the single user in a local laboratory to the fully connected enterprise version for the entire organization.
Recently CAMO went into an agreement with Lonza to provide them with an adapted enterprise version of Process Pulse. The solution connects directly to multiple 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, enabling real-time quality control. The recorded data is also available for future data analysis, troubleshooting and product traceability.
Data gathering and evaluation is becoming more important in the total life-cycle of a product and not just in the commercial scale production. Building processes start in the R&D labs and should be validated in the production plants. To close the gap between lab scale and production scale, the PAT data management software should be able to bring all data into one common platform.
The time consuming manual work will be supported and fully automated by the Process Pulse software. The main aspects are:
- Merging of multivariate and univariate data sets
- Bring data to a common time axis
- Identification of Batches
- Cleaning up of data sets
- Detection of interessting process steps
- Creation of Overlays
One example of combined data from lab scale and production scale shows the figure 1. Due to the overlay of all batch trajectories the variance and the scaling effect can easily be demonstrated.
Figure 1: Combined Information of small scale and large scale batch trajectories in the PCA Score coordinate system.
The integration of a PAT data management system into the development workflow is an important step to close the gap between R&D and production. And, process understanding becomes more integrated in daily business.
This Application Note was prepared by Dr. Geir Rune Flåten and co-authored by Dr. Tobias Merz, PAT Team Leader at Lonza AG.