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Modeling the manufacturing process benefits both development and operations.
Digital twins of manufacturing processes are being explored in pharmaceutical manufacturing for the benefits that can be harnessed from a real-time simulation of the actual process. In 2020, GSK partnered with Siemens and Atos (a digital transformation company and a long-time Siemens partner) to pilot a digital twin for their vaccine manufacturing process that modeled and controlled the adjuvant particle manufacturing process. The partners succeeded with the project goal of proof of concept, and GSK is now seeking to replicate the digital twin concept on an industrial scale for its vaccine development and manufacturing platforms.
“Industry 4.0 concepts, such as digital twins, are generally thought to be a good idea, but this project created belief that it can really be used in vaccine development and manufacturing,” says Matt Harrison, head of Sciences, Digital Innovation, and Business Strategy at GSK Vaccines. “Now we are developing a vision for using it for multiple products and platforms, and we are deciding which opportunities will best deliver value and have the most impact.”
A significant benefit of the digital twin was that the model allowed developers to better understand the relationships between process variables to control variability.
“Controlling variability allows us to improve quality and make product ‘right first time’ every time,” says Harrison. “The model and the high degree of process control also allows us to better predict and optimize product yield. The aim was to build the twin during process development and then use it in manufacturing. The digital twin is an additional ‘deliverable’ of the development process.” Doing the work to understand and optimize the process “in silico” in the digital twin, rather than actual experiments with real material in a lab or test facility, saves a significant amount of time, materials, and cost.
Although the team has not yet gone through a tech transfer between manufacturing facilities using the digital twin, in theory, the ability to model any differences in scaling up or moving from one facility to another will reduce tech transfer risks, says Harrison.
Factors in the success of the pilot project include strong backing from GSK leadership and good teamwork both between GSK departments and with partners Siemens and Atos, notes Harrison.
Another key to the project’s success was that we started small and focused on our goal of demonstrating the concept. The next challenge is industrialization—using digital twins at scale in both development and operations throughout the organization. This effort will require continuous improvement, and we expect we will need to continue to make software and hardware changes as we further develop our capabilities,” says Harrison. “Although there are certainly technical challenges ahead, the aim is for digital twins to become routine.”
Harrison asserts that digital twins will be useful not only for process control in the operation of manufacturing facilities, but for the future of vaccine development. “When designing a vaccine, manufacturability is crucial. Having a digital twin to develop understanding of the manufacturing process is a key benefit,” he explains.