Siemens and BioNTech, a fully integrated biotechnology company developing personalised cancer immunotherapies, have entered into a strategic collaboration. BioNTech’s subsidiaries, BioNTech RNA Pharmaceuticals and EUFETS, will work together with Siemens on the construction of a fully automated and digitalised production site to provide capacity for BioNTech’s personalised 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 individualised vaccines at a larger scale.
This strategic collaboration brings together each partner’s specific competences in order to optimise automation and digitalisation technology for a paperless, commercial-scale GMP (Good Manufacturing Practice) manufacturing of personalised medicines.
Ugur Sahin, CEO of BioNTech, said: “We are pleased to partner with Siemens on automating a specialised, proprietary manufacturing process for truly personalised medicine. Siemens’ world-class expertise in engineering and optimising automatic manufacturing processes will be of great value in making personalised cancer treatment for patients available to all.”
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. It 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).