Siemens, a global technology powerhouse, and BioNTech AG, a fully integrated biotechnology company developing truly personalized cancer immunotherapies, have entered into a strategic collaboration.
BioNTech AG's subsidiaries, BioNTech RNA Pharmaceuticals GmbH and EUFETS GmbH, will work together with Siemens on the construction of a fully automated and digitalized production site to provide capacity for BioNTech's truly personalized cancer vaccines to serve worldwide markets. The cooperation will enable BioNTech to establish and integrate all necessary process and production steps for manufacturing its Ivac individualized vaccines at a larger scale.
This strategic collaboration brings together each partner's specific competences in order to optimize automation and digitalization technology for a paperless, commercial-scale GMP (Good Manufacturing Practice) manufacturing of truly personalized medicines.
Ugur Sahin, CEO of BioNTech, said: "We are pleased to partner with Siemens on automating a specialized, proprietary manufacturing process for truly personalized medicine. Siemens' world-class expertise in engineering and optimizing automatic manufacturing processes will be of great value in making personalized cancer treatment for patients available to all."
Eckard Eberle, CEO of the Siemens Business Unit Process Automation, added: "The development and manufacturing of personalized medicine is connected with massive amounts of data. Solutions such as our manufacturing operations management (MOM) software are able to handle the complexity of this innovative new process technology. Together with BioNTech's competence in individualized medicine, we will pave the way for a digital plant with an efficient and completely paperless production."
The Ivac Mutanome Immunotherapy approach is based on targeting the unique mutation signature of an individual patient's tumour. It is engineered on demand and administered as an individual treatment. Ivac Mutanome is currently in a phase I/IIa clinical trial for the treatment of malignant melanoma.
Siemens offers a paperless manufacturing solution for enhancing both efficiency and product quality, while at the same time bringing down costs. Fully integrated communication is established between the automation level and manufacturing IT. As a central access point for all process and quality relevant data, the solution links advanced scheduling with the manufacturing execution and the laboratory management system. This enables complete electronic recording and documentation of quality-related production data, while eliminating time-consuming manual procedures and paper-based batch reports. Paperless manufacturing thus accelerates the design, execution, review and release of pharmaceutical production processes and electronic batch records (EBRs).
BioNTech RNA Pharmaceuticals GmbH is a fully-owned subsidiary company within the BioNTech AG Group. The company is a technology leader in the rapidly growing field of synthetic messenger RNA (mRNA) therapeutics.
Founded in 1997, EUFETS GmbH specializes in services for innovative therapeutic approaches. In 2009, EUFETS became a 100% subsidiary of BioNTech AG, endowing BioNTech with synergistic platforms and complementary expertise for development, testing and manufacturing services.