Person in a full cleanroom suit working with a large piece of stainless steel industrial equipment.

Vaccine production: BioNTech has the right stuff

One of the vaccines that provides particularly good protection against COVID-19 is BNT162b2 from Mainz-based biotech company BioNTech. To scale-up the manufacturing capacity further, the company has begun production in Marburg — and relies on the expertise available at Siemens.

Full speed ahead thanks to total commitment

Now the hopes of society depend especially on this project. A project of this magnitude normally takes about a year, but in this case the participants completed the conversion in just five months. Main components of the new manufacturing execution system (MES) were completed in only two and a half months. “One factor that made it possible was the high level of cooperation between the teams and outstanding commitment by everyone involved,” states Andreas Haag, in charge of the project for Siemens.

In focus: Industry 4.0

All the improvements at the Marburg plant are Industry 4.0-compatible. One of the challenges with the conversion was the fact that it involved switching from rigid to mobile production with many single-use components. At the same time, working with mRNA meant a higher clean room class than was previously required in the facility. Paper is now an avoidable “contamination factor” that doesn’t arise with digital production. That was the basis for opting for the Opcenter Execution Pharma solution from Siemens as the new MES. This solution enables complete paperless manufacturing and fully electronic batch recording.

High degree of automation and digitalization

Seamlessly integrating automation solutions makes it possible to develop, optimize and manage production processes automatically. Because mRNA processes include a lot of manual stages — weighing, for example — operators require guidance through these. This is provided by the workflow management component of the software. Opcenter Execution Pharma orchestrates the various sections of the system to ensure efficient production.

To automate the facility, all systems were converted to the latest version of Simatic PCS 7. The powerful, flexible and scalable distributed control system steers and controls all the processes in the plant and takes digitalization to field level.

A vial of Pfizer-BioNTech COVID-19 vaccine.

We want to thank Siemens for their excellent collaboration on this project and the huge effort they put in, often exceeding 100 percent.

Valeska Schilling, Head of Production Department, BioNTech Marburg

Paperless production: more efficiency and quality

Paperless production offers advantages over traditional procedures in the pharmaceutical industry in particular. Electronic Master Batch Record Management enables users to create, execute, review and release Master Batch Records (MBR), and Electronic Batch Records (eBR) are made faster. Testing is based on the principle of “review by exception” — in other words, deviations are dealt with when the system recognizes them based on exception rules. That makes the testing process less labor-intensive. As a result, digital production is a significant factor in making the process faster and improving quality.

Collaboration for a smooth start of production

To provide a smooth start of production, Siemens is supporting the implementation of the system at BioNTech with Hypercare and a 24/7 project-based standby arrangement. The project is a complete success for both parties and production was able to start before the end of February with the production of the drug substance: the mRNA. “We want to thank Siemens for their excellent collaboration on this project and the huge effort they put in, often exceeding 100 percent,” says Valeska Schilling, Head of Production Department at BioNTech Marburg. Both companies plan to intensify their collaboration for the rapid expansion and creation of production capacity for the COVID-19 vaccine. The aim is to establish new production sites for COVID-19 vaccine production worldwide based on the Marburg plant and its technology, starting with a production facility in Singapore. Within this cooperation, Siemens will provide the latest automation and digitalization technologies for BioNTech production sites, such as design, simulation and engineering software as well as process control technology.