We’ve all seen images of highly automated robot-filled factories assembling complex things like cars and televisions, all with high precision and efficiency. These new digital factories are now coming to the manufacturing of biopharmaceutical medicines.
Sanofi is already working on this digital transformation, starting with an EU manufacturing site in Geel, Belgium and a US facility in Framingham, Massachusetts. We are adapting many of our existing plants and building new facilities using this ultra-modern approach, ensuring they are more productive, agile, flexible and cost-effective. In this new environment, scientists, operators and technicians are able to focus mainly on improving manufacturing processes and ensuring the quality of our medicines for patients, because repetitive and manual activities are eliminated that can cause human errors.
Developing the next generation of digital manufacturing for biopharmaceuticals is part of Sanofi’s company-wide digital strategy. It is essential so we can produce increasingly complex medicines on a scale large enough to reach growing patient populations that will rely on biologics for improved health. According to a study by EvaluatePharma, while traditional drugs accounted for about 70 percent of the top 100 medications marketed globally prior to 2010, half of all medicines will be biologics by 2022.
Over the last five years, Sanofi has prepared for this profound shift by investing €4.7 billion ($5.51 billion) to build production capacities, including an ongoing investment program in biologics of around €600 million per year by 2020 to boost biotech capacity.
Sanofi’s digital plants will be equipped with modern sensors across all buildings and equipment. Our employees will work alongside “Cobots” – collaborative robots that recognize their environment to operate safely and Autonomous Mobile Robots (AMR) will automatically transport raw materials, single-use equipment and finished products to different points in the facility. Advanced analytics on data from all these systems will help identify and correct potential issues on the factory floor and continuously optimize flow and orchestration of activities. Augmented reality for our technicians, paperless shop floor operations with mobile solutions and seamlessly integrated quality labs will also play key roles.
Each one of these new plants will have a “digital twin” – a 3D computer model of the actual plant, connected directly to all the sensors and data in the physical factory. The data flows to these digital twins giving managers a real-time view into the plant’s operation. Simulation on the model provides the level of manufacturing modularity and future flexibility required to support personalized medicine.
“I see great scope for using digital models and simulations to transform how we plan, design and operate our facilities from the concept through to delivering products to patients,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs, Sanofi.
In Geel, Sanofi’s state-of-the-art biologics plant is a good example of this digital twin approach with sensors throughout the facility measuring more than 5,000 parameters along the production process. These sensors generate over one billion data points in every single manufacturing cycle. By analyzing this data, potential deviations can be spotted and swiftly corrected. Yield is improved with adaptive process control strategies and downtime is reduced by optimizing maintenance activities and shifting to predictive maintenance, based on equipment monitoring, which will increase overall output.
The Framingham location is a key example of our vision for a next-generation biologics manufacturing facility. Sanofi is making substantial investments in flexible facility design, so that the factory can produce different products using much of the same equipment for all of them. The factory is also fully paperless, leveraging the latest advances in IT, with batch record reviews being completed digitally, which will facilitate shorter cycle times for product release and earlier availability of products for patients. Maintenance and calibration have also been transformed into paperless operations, while digital content will be used for employee training. Along with other investments in advanced cell biology methods to increase yield, this factory of the future will support our ambitions to be more flexible in responding to the pipeline and in producing the highest quality products at lower costs, improving availability and affordability of our medicines for patients.
To drive such a change, Sanofi relies on our own experts who understand pharmaceutical and biological manufacturing and draw inspiration from other leading industries. But it is also thanks to partnerships with innovative start-ups in areas such as drone technology, operational analytics and artificial intelligence. We are also very focused on digital visual management tools as provided by the start-up iObeya that help drive our performance and increase familiarity with digital solutions.
As the digital factory changes the face of Sanofi’s plants, it will also change the work day for employees. Operations staff will increasingly shift focus from manual tasks to how we can improve the control and throughput of our operations, by monitoring process performance in real time. They will be supported by digital collaboration, data analytics or augmented reality solutions which give operators immediate access to the best expertise within the company or from external providers. Additionally, we are investigating and implementing the use of robotics to eliminate routine manual tasks both on the production shopfloor and in labs which will also improve safety and control of those activities.
Advances like those in Framingham and Geel are paving the way for a new generation of plants and investments in Sanofi. These upgrades are only successful through strong investment in people. This is why we are undertaking significant training within our Sanofi Manufacturing System through which we are also developing a digital mindset and capability at all levels of industrial affairs: in the last three years, more than 1,100 employees have been trained internally. This investment ensures our people are trained for the future so we can continue to produce high-quality medicines in the new age of biologics.
 EvaluatePharma August 2016