One of the vaccines that provide particularly good protection against Covid-19 is BNT162b2 from biotech company BioNTech. To scale-up the manufacturing capacity further, the company relies on Siemens.
The company has started manufacturing at the production site in Marburg, Germany. The plant comes with an ultramodern production facility for recombinant proteins. BioNTech also acquired a highly qualified employee base along with the production facility, all of whom are experienced in developing new technologies.
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.
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. It enables complete paperless manufacturing and fully electronic batch recording.
Integrating automation solutions makes it possible to develop, optimize, and manage production processes automatically. Because mRNA processes include a lot of manual stages 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 flexible and scalable distributed control system steers and controls all the processes in the plant and takes digitalization to field level.
Paperless production offers advantages in the pharmaceutical industry. 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” – 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.
Siemens supported the implementation of the system at BioNTech with Hypercare and a 24/7 standby arrangement. The project is a complete success for both parties. “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. The aim is to establish new production sites for Covid-19 vaccine production worldwide based on the Marburg plant and its technology. Within this cooperation, Siemens will provide the latest automation and digitalization technologies for BioNTech production sites.
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