Biogen uses the PI System to bring Alzheimer’s drug within reach
- ChallengeDeliver new Alzheimer’s drug, Aducanumab, affordably to 1 million patients by 2020.
- SolutionIntegrating real-time operational data with process control in Next Generation Manufacturing facility.
- BenefitsWait time for test results reduced by 50%, batch exceptions reduced by 70%.
A next-generation manufacturing process
Biogen’s goal was to treat one million more patients by 2020. To make that happen, the company needed to make Aducanumab more affordable—and affordability starts with production. Biogen’s long-term goal was to cut costs from $10,000 per gram to $100-$150 per gram. The team created a Next Generation Manufacturing plan for Biogen’s production facility in Solothurn, Switzerland, using the PI System to integrate real-time operational data with a modular facility designed for expansion.
With an ambitious cost reduction goal, Biogen needed to tackle multiple aspects of production. Optimizing the manufacturing process meant minimizing the screening time for raw materials without sacrificing quality, implementing process and quality controls, and developing predictive models for consistency assessment. Biogen needed the power to correct potential issues with processes before it reached the end product stage, and the key to making that happen was using real-time data to monitor and control processes as they were occurring.
“When we look at our current processes, although we’ve worked really hard to optimize them, we still have some challenges,” said Tim Alosi, head of Biogen’s Global Data Analytics team. “With next-gen manufacturing, our goals bring together some of these initiatives and enable them with strong, integrated IT systems.”
The Biogen integrated solution
Advanced process control allows Biogen to make dramatic cuts in the time spent on product testing. No longer a discrete step at the end of the production line, testing is now an integral part of production on the plant floor. “If you have to wait two to three days for a lab result, then it’s really hard to have a positive impact on a purification process when three days later you’re two steps beyond where you were,” said Alosi. “How can we bring these sorts of technologies right down to the shop floor so that decisions can be made in real time to affect the process?”
Biogen met the challenge of integrating testing into the production line and it dubs its solution the BES Integrated Solution. Comprised of 58 different interfaces, with the PI System as the data backbone of the project, the technology ecosystem is designed to provide the real-time visibility and context needed to implement advanced process controls and predictive modeling.
Real-time review by exception
Biogen’s production monitoring system keeps data in context. Asset Framework, the contextualization layer of the PI System, and Event Frames, a PI System component that captures critical event context such as start and end times of processes, help Biogen managers track important production metrics in the context of what is happening on the floor. “The key element here is that context. It’s not just time-series data, it’s the time-series data coupled with the manufacturing context that enables these different applications,” said Alosi.
Events are created at a source system level, exposed, and stored in the PI System in real time. Other components of the PI System, Alarms and Notifications, generate real-time reports on quality or process issues and send workflows to supervisors. Using these reports, Biogen is often able to address issues before a batch moves to the next step, instead of scrapping an entire batch due to an error in the production process.
With real-time review by exception, Biogen can now adjust its manufacturing process in real time, allowing the company to reduce manufacturing costs, increase yield, expand production efforts—and ultimately, put a life-changing drug into the hands of more patients worldwide.
For more information about Biogen and the PI System, watch the full presentation here.