Software-Optimized Production Processes at BioNTech

Fraunhofer ITWM Researchers Develop Platform for Planning and Coordination of BioNTech’s Drug and Vaccine Production

Ever since the Mainz-based company developed the first broadly approved vaccine against COVID-19, the name BioNTech has been widely known. The real concern of BioNTech SE is the development of individualized therapy for cancer patients. For both use cases – the production of the individualized cancer drugs as well as the Corona vaccine – researchers at the Fraunhofer Institute for Industrial Mathematics ITWM have developed a software platform that can be used to control the production process more effectively.

The production of individualized drugs is complex from both a technical and an organizational perspective and differs fundamentally from established processes in the pharmaceutical industry. Individualization raises a variety of novel issues and requires new approaches to production organization and planning. For example, all steps must be carried out individually for each patient. For many years, this was not the focus of established solutions for production planning.

ITWM Team Develops Individually Tailored Solution

To develop a platform that plans and coordinates these processes is the task of the team around Dr. Heiner Ackermann, deputy department head of »Optimization – Operations Research« at Fraunhofer ITWM. First, the previous knowledge of the scientists at BioNTech had to be combined with that of the ITWM researchers. »Finding a common language, a common understanding of the process, was an essential part of our work,« says Ackermann. Modeling, structuring, and analysis of data and processes followed. The end result was software that could be used to plan and organize the manufacturing processes for individual drugs and provide a completion forecast for each patient.

Modeling and Simulation as the Basis for Software Development

The basis for the team's work is ITWM's expertise in modeling and simulation. »We have a lot of experience in analyzing the individual challenges of production processes. Based on this, we develop concepts on how the respective processes can be optimized and better controlled. Then, we create digital twins of the processes and simulate the interaction of the different aspects in order to evaluate the concepts,« Ackermann explains the background of the development work.

Automated Processes for Increasing Production Numbers

Several of BioNTech's oncology product candidates are already in advanced stages of development and will soon enter pivotal trials. Manufacturing for commercial distribution is already being prepared today. This also has an impact on the planning processes: They sometimes need to be adapted and expanded, particularly with regard to greater automation. Preparations for this are already underway. »With a few hundred patients, manual intervention in the process is still possible. This will no longer be possible with several 10,000 patients. Automated processes and additional decision support options may be required there,« says Ackermann, describing the advantages of an automated planning process.

BioNTech’s COVID-19 Vaccine
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The researchers at Fraunhofer ITWM continuously adapt the software to the changing requirements in vaccine production.

And Then Came Corona

With the onset of the Corona pandemic, BioNTech is also using its expertise on mRNA-based anticancer drugs to develop a vaccine. »I learned from a newspaper article that BioNTech was planning to develop a vaccine. Shortly thereafter, the company inquired about working with us on new software solutions. That's when chaos briefly broke out for me, but of course we got to work,« Ackermann looks back.

Unlike cancer therapy, vaccine production does not have to assume the individual characteristics of patients. The vaccine production process is therefore much less complex than that for individual cancer drugs. Critical here is the production capacity for the hundreds of millions of vaccine doses required. The solution is for BioNTech to work with contract manufacturers who specialize in specific process steps.

Fraunhofer ITWM and BioNTech have built software that allows the company to plan, coordinate, and document the production network and the individual process steps. »Now we are working on adapting the platform to the ever-changing requirements. As the production process evolves, so does the platform,« says Ackermann, describing the ongoing collaboration.