New standards for safe pharmaceuticals manufacturing: Freiburg Healthcare Hub enables cooperation between IT start-up Mondas and Pfizer.

Pharmaceuticals such as capsules and tablets are "goods of a special kind". They have to meet the highest quality standards, which is why their production is subject to special regulations. This is the case at our Pfizer production site in Freiburg, where a wide variety of medicines come off the production line here every day. Last year alone, a total of more than 200 million packages were produced across Germany. To ensure that the quality of the medicine can be guaranteed at all times, there is a tightly meshed control system in the manufacturing plant. If even the slightest deviation in quality parameters is detected during production, all production must be temporarily interrupted. Any machine downtime means an interruption in patient care and production losses.

To further expand existing production and supply technology, utilize digitization and improve safety and efficiency, a specialist department of Pfizer came to us, Healthcare Hub Freiburg, in February 2019. The goal was to develop an innovative solution for prediction, monitoring and fail-safe control of production machinery.

From scouting to business case: matchmaking with the IT start-up Mondas

No sooner said than done: after defining the requirements by the specialist department, we set out on a search. The first port of call from our network of partners was the Smart Green Start-up Accelerator, based in the Lokhalle in Freiburg. The team led by Philipp Rottmann, program manager at the Smart Green Accelerator, brings start-ups together with companies as part of the GROW program, accompanying them in the development and implementation of the cooperation. In a nationwide scouting phase, we set out with the Smart Green team to search for innovative industry start-ups. The potential candidates were screened and evaluated together with Pfizer's specialist department. Among them was Mondas, an IT start-up that emerged as a spin-off from the Fraunhofer Institute for Solar Energy Systems (ISE). With the help of an intelligent IoT platform, Mondas enables companies to monitor large plant inventories and thus prevent production downtime at an early stage. When we got to know that Mondas is also based in Freiburg it became clear to us, it's a match!

Since the cooperation required enormous technological know-how and expertise in the use of data science solutions in industry, we decided to bring Siemens on board as a technology partner. During the joint development of a business case, the colleagues from Siemens were already able to contribute valuable impulses for a suitable use case in their role as mediators. After an intensive work process, the decision for a business case was made in November 2019: the development of a monitoring system for deviations from the so-called "Good Manufacturing Practice" (GMP). Since inaccuracies in room temperature or humidity in particular lead to a production stop in medicine manufacturing, the task now was to find a solution for this.  

Objective: New standards for fail-safe pharmaceuticals production of the future 

Once the objective was clear, the planning phase began in June of this year. Together, the plant was inspected and the production problems that were to be taken into account as part of the collaboration were specified. Furthermore, measurement and evaluation concepts were drawn up and the provision of data via the interfaces was determined. From this, a project plan was developed, which was presented at the end of November by the project manager Hans Zebner from the Hub Freiburg - and the result was convincing!  

Pfizer's specialist department is now planning a proof of concept (PoC) with Mondas in order to develop an IoT platform based on the joint work that is adapted to the individual manufacturing conditions in Pfizer's medicine production. In the future, the measured room climate values as well as the operating states of the systems will be analyzed in a matter of seconds and reported at an early stage in the event of deviations. The rule-based error detection of Siemens control technology will also be used in the analysis.   

"We are looking forward to future collaboration with Pfizer and Siemens," says Mondas project manager Christian Neumann. "The project offers us a great opportunity to make the future of pharmaceutical production safer and more efficient with the help of IoT technologies." 

Next year, the PoC will be launched at Pfizer in Freiburg, Germany. It is also conceivable that it could be used in new production facilities, as errors could then be identified during trial operation and remedied at an early stage. New factories and plants could thus go into operation more quickly and the production and supply of required pharmaceuticals could be guaranteed at an early stage.  

Strong partnerships: How co-creation works in the Freiburg innovation ecosystem  

The project with Mondas has shown how the innovation potential in sustainable industrial production can be leveraged with the support of the network of the Freiburg innovation ecosystem, visible through startinsland. All stakeholders have brought their respective strengths to the collaboration, setting the course for the efficient and safe pharmaceutical production of the future. We look forward to future tasks and challenges that we will tackle together with committed founders, supporters and industry partners.