by Carrie Mason
Senior Manager, PS&T PAT & Automation CoE
By leveraging our own technologies, Lonza now offers more accurate Process Analytical Tools (PAT) at a reduced cost for customers
Imagine if instead of seeing glimpses of data in your process, you could see a continuous data stream?
To provide consistent, safe, and high-quality products for customers and the patients they serve, it is critical to monitor and control bioprocesses.
Current bioprocess monitoring and control schemes still rely on infrequent and time-consuming offline sampling methods. This leads to loopholes in data and major gaps in knowledge, as well as an increased cost.
Having a clear picture of the system, instead of relying on discrete snapshots throughout the day, opens the possibility to see what is really happening with the product profile.
Process Analytical Tools -- better known as PAT, a mechanism to design, analyze, and control pharmaceutical manufacturing processes – provide real time data to improve the process robustness and reduce cost.
A New Method
In order to reduce errors and enhance efficiency, while improving the quality of the product, Lonza formulated a new PAT strategy by leveraging existing technologies and R&D set-up, and bringing PAT into the digital age. This new method not only fills the gaps of previous PATs and improves the quality of the data, but also reduces the cost of the system and the initial upfront investment.
To get rid of the variability in the process during production, which may impact the product quality profile, Raman probes are used to monitor changes of critical bioprocess parameters such as cell counts and metabolite concentrations. Continuous analysis of these components enables operators and data scientists to monitor cellular metabolism and growth while providing mechanisms for continuous process adjustments to maintain nutrient levels at desired targets.Adjusting the bioprocess in this way yields a reproducible process yielding product that meets SISQP standards each and every time
Better Results for Our Customers
The key is that the process itself doesn’t change; the way in which information is obtained about the process does. Lonza is unique in that we are one of the few CDMOs incorporating a platform-based PAT strategy that can work independently, without relying on the customer process.
This results in quick wins with more accurate information. Meaning, there is no disruption to the process. Our customers get access to data from the entire process and a better understanding of how the cultures are growing. For example, when monitoring viable cell count (VCC) in real time, abnormal growth profiles can quickly be identified and flagged.
PAT of the Future
Previously, PAT had only individual data points. Now one can see the entire process, even between data points, and get a better understanding of how the cultures are growing. Better process understanding enables more robust process control resulting in fewer lost batches and higher productivity.
By leveraging existing R&D technologies and the method of customer access, we are eager to see the results of our customers’ products, without requiring the typical large upfront investment associated with traditional PAT.
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
Certain matters discussed in these articles may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in these articles due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in these articles.