By Lisa J. Graham, Ph.D., PE, Vice President of Analytical Engineering, Seeq
Regulatory support and technological innovations have fueled the adoption of continuous manufacturing in the pharmaceutical sector in recent years, showing a shift towards operational excellence marked by rapid production in multipurpose facilities, a reduced scaling risk and higher quality expectations. The end-to-end, integrated and scaled-up drug manufacturing approach offers a wide range of benefits that help achieve industry goals of increasing the efficiency of drug development and manufacturing while by reducing costs. With continuous manufacturing, you only need to run the process longer to generate the required volumes, greatly reducing the delays and risks associated with scaling up batch manufacturing. Maintaining a steady state of production with continuous manufacturing also eliminates batch variability and improves product quality and availability. By facilitating scale while simultaneously ensuring high quality, continuous manufacturing opens the door to accelerating development through to the commercial launch process.
However, the complexity of how quickly the data must be analyzed is greater with continuous manufacturing. The start and stop stages of batch manufacturing allow more time for analysis and decision making as opposed to continuous processing, where material quickly moves from one unit operation to the next. Therefore, scans need to be done faster to quickly identify any issues and take action before valuable product is lost. Additionally, continuous manufacturing consists of interdependent unit operations, where control of a single unit operation affects what happens in the next, requiring a greater level of understanding about how the different steps interact. Therefore, implementing continuous manufacturing requires a strong data collection and integration strategy across your organization.