Siemens and BioNTech have partnered to establish a paperless, commercial-scale good manufacturing practice (GMP) production facility for personalised cancer vaccines.
The strategic collaboration will focus on construction of a fully automated and digitalised production site to provide capacity for BioNTech’s IVAC individualised vaccines to serve worldwide markets.
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BioNTech’s IVAC Mutanome Immunotherapy approach, currently in a Phase I/IIa clinical trial for treatment of malignant melanoma, targets the unique mutation signature of an individual patient’s tumour.
Subsidiaries BioNTech RNA Pharmaceuticals and EUFETS will work with Siemens on construction of the site and to establish and integrate all required process and production steps for larger scale manufacturing of the vaccine.
Siemens Business Unit Process Automation CEO Eckard Eberle said: "The development and manufacturing of personalised 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.
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By GlobalData"Together with BioNTech’s competence in individualised medicine, we will pave the way for a digital plant with an efficient and completely paperless production."
Siemens’ paperless manufacturing solution not only enhances both efficiency and product quality, but also reduces costs.
The solution serves as a central access point for all process and quality relevant data, connects advanced scheduling with the manufacturing execution and the laboratory management system.
This paperless manufacturing also enables complete electronic recording and documentation of quality-related production data, while accelerating the design, execution, review and release of pharmaceutical production processes and electronic batch records (EBRs).
