Industry software: Personalized therapy
With its personalized vaccine, BioNTech is a pioneer in the battle against cancer. To enable the active pharmaceutical ingredient (API) to be produced faster and in large quantities, the company has installed an entirely paperless manufacturing system featuring Simatic IT eBR and Preactor.
The development of personalized therapies was long considered a daring experiment, entailing major challenges – not just scientifically, but also in terms of production costs and time. In recent years, however, new developments in the field of oncology have shown that personalized therapies might well be able to revolutionize cancer treatment in the foreseeable future.
Personalized therapy at an affordable cost
BioNTech AG in Mainz, Germany, works on tailored medications, developing new-style, personalized immunotherapies against cancer and other serious illnesses. To this end, the biotech company is pushing ahead with its IVAC® (Individualized Vaccines Against Cancer) Mutanome platform to make personalized cancer therapies available rapidly and at an affordable cost.
BioNTech CEO Ugur Sahin explains: “The production of the IVAC® Mutanome individualized vaccine is based on a standardized process that enables the creation of tailored products that vary widely in their composition according to individual patient characteristics.” This is initiating a paradigm shift in clinical development: the focus is no longer on the end product as such, but rather on the overall production process of medications tailored to individual patients. This approach also entails new conceptional, regulatory, technological, and clinical challenges. Immunotherapy using IVAC® Mutanome is based on decrypting the individual mutation patterns of tumors in each individual cancer patient. The appropriate synthetic RNA vaccines are then produced, matched precisely to the mutation profile for each patient.
The production of the IVAC® Mutanome individualized vaccine is based on a standardized process that enables the creation of tailored products that vary widely in their composition.Prof. Dr. Ugur Sahin, CEO, BioNTech AG
Experienced digitalization partner
To test and verify the efficacy of these new-style therapies in extensive study programs, two key prerequisites must be met: first, the production of the personalized vaccines needs to be accelerated, and second, the vaccines must be made available in larger quantities. Running production processes in parallel and speeding them up can achieve higher capacity. Paperless manufacturing is essential to this process.
Since 2015, in its efforts to optimize production time and costs, BioNTech has been drawing on Siemens’ extensive experience in digitalization to establish a fully automated, paperless, digital manufacturing process. Sahin says, “We aim to be in a position to provide hundreds of thousands of patients with personalized medications within less than five years. That will require the development and convergence of innovations in a range of different advanced technologies, such as big data, artificial intelligence, and fully automated analytics and production lines. The various components will in the future be fully digitalized and will collaborate with each other within interconnected processes.
We believe Siemens has the necessary know-how to provide us with optimal support in attaining our goals.” BioNTech also greatly appreciates Siemens’ extensive portfolio and large workforce, which enable it to handle even such major projects quickly and reliably.
High quality thanks to automation
The Simatic IT eBR and Preactor manufacturing execution system (MES) are used to implement paperless manufacturing. As a result, the necessary information can be retrieved from all production processes and subsequently analyzed, archived, and applied to generate reports. This creates “regulated” flexibility, which is an essential element of state-of-the-art pharmaceutical manufacturing. The solution almost entirely eliminates time-consuming manual actions – whether in the lab, in production, in logistics, or in quality assurance. Full automation enables personnel to be deployed in an optimal way, process steps to be executed correctly, and releases to be issued as and when required. This is important in terms of the quality of documentation, and thus for compliance with all internal and regulatory requirements.
Because the production of IVAC® Mutanome vaccines takes several weeks and involves a sequence of process steps, precise operational planning is essential. The unified MES solution comprising Simatic IT eBR and Preactor links two separate operating locations into a single continuous process – from production planning to analysis to the finished personalized medication in lot size 1.
Siemens successfully ran a concept study beforehand and subsequently drafted the functional specifications in the blueprint phase. The company’s comprehensive process and pharmaceutical know-how, combined with the deployment of an experienced project team with high-caliber experts, proved ideal. The contract also includes the factory acceptance test (FAT) and site acceptance test (SAT), as well as the production of qualification documents.
Pioneering role as a challenge
With its pioneering role in research, clinical testing, and manufacturing, BioNTech is well on its way to revolutionizing the treatment of cancer through personalized mRNA-based immunotherapies. “Our pioneering work routinely throws up challenges that we have never before encountered, which means we must continually come up with new ideas and methods in order to find appropriate solutions,” states Sahin.
Thanks to the global presence of Siemens and the commitment of an international team, all the preconditions for implementation of BioNTech’s planned global production rollout were met. The first market approval of the new vaccine is scheduled for the year 2021.
Picture credits: BioNTech AG
BioNTech is a holding company with several subsidiaries combining all the technology platforms and competencies for research, clinical development, and marketing under a single umbrella. The subsidiaries specialize in different, complementary biopharmaceutical and diagnostic platforms and in the manufacture of medications for human use.
The company’s strategy is to devise new technologies and converge innovations in order to develop and market personalized treatment approaches offering unique medical potential. As a result, BioNTech has in recent years taken on a pioneering role in the field of personalized cancer vaccines. Because every cancer case exhibits differing features, an average of only 15% to 30% of cancer patients with advanced tumors benefit from commonly available drug treatments.
Treatment tailored to the individual cancer and patient is expected to deliver much higher therapeutic success and improve chances of a cure.
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