Head of Analytical Development, Microbial, Lonza
Currently, bioprocess monitoring and control systems rely on infrequent and time-consuming offline sampling methods. This can lead to loopholes in data and major gaps in knowledge, as well as increased costs. To help ensure a successful bioprocess monitoring and control operation, it’s important to have a comprehensive and clear picture of the entire system, instead of relying on discrete snapshots throughout the day.
Another challenge the industry faces is the inability to measure online key process variables, such as cellular metabolism. By addressing these challenges, we can help improve quality, efficiency, and return on investment throughout the process.
Using the QbD approach
Lonza’s Process Development Service team uses a quality-by-design (QbD) approach during process development to reduce the amount of required offline analytics by reducing process variability. In the earlier stages of development, our experts use a QbD approach to evaluate the impact of each unit operation and manufacturing instrument, and this is then followed by defining the criticality of the process parameters as well as acceptable operating ranges in appropriately designed experiments.
Implementing a QbD approach can help ensure that upstream processes are efficient and reliable from early-stage development through commercialization.
In addition, Lonza recently formulated a new strategy for process analytical technology (PAT) that leverages existing technologies and the R&D setup to bring PAT into the digital age. PAT is a mechanism to design, analyze, and control pharmaceutical manufacturing processes and provides real-time data to improve process robustness and reduce costs.
Previously, PAT had only individual data points. Now, we can see the entire process, even between data points, and our customers get access to this data and have a better understanding of how the cultures are growing. This new method not only fills the gaps of previous PAT strategies and improves data quality, but also reduces system costs and the initial upfront investment.
Mirza Jakupovic is head of analytical development, microbial, at Lonza.