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Digitized production for personalized medicine

The vision of BioNTech is to revolutionize the tumor treatment with medicine tailored specifically for each patient. Discover how our software for digital production brings the vision closer to reality.

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Visit us in Hall 9, Booth D35, April 24, 2017

Hannover Fair

With this year’s motto “Discover the value of the Digital Enterprise”, we present comprehensive solutions for the discrete and process industries. With the connection of all machines and plants, we create competitive advantages.  

The vision

Medicine tailored for the patient

There is barely any other disease as particular as cancer. That is what also makes it so hard to treat. A emerging biotech company believes it is close to a solution – with an approach that considers the genetic profile of each and every patient as well as their condition. The vision of personalised tumor vaccines, however, is blurred by an extremely complex research and production process. Our software helps to bring this vision a little closer to reality.

The future of tumor treatment could emerge from BioNTech AG's Mainz-based research centre. Company founder Prof. Ugur Sahin and his colleagues are hoping that the fruits of their labour will fulfill a long-cherished dream: a treatment that essentially offers each and every patient realistic chances of recovery.  

 

One of the reasons why such a personalized treatment has not yet successfully been developed lies in the singular nature of cancer diseases. Tumors are created by random gene mutations and not one patient has the same clinical picture. BioNTech's vision is to tailor tumor medicine specifically for these unique clinical pictures. In other words: to apply genetic analysis techniques to identify mutations and to produce a proprietary medication that ultimately mobilises the patient's immune system against the mutant cells.

 

The fastest way from the lab to practical applications

 

Until recently, such a procedure would have been destined to fail due to the immense effort required in practise. Only modern digitalization and automation technology allows personalised medicine to be produced in adequate quantities for clinical studies and hence meet the preconditions for a possible market introduction.  

 

At BioNTech, our software plays a key role: the company uses SIMATIC IT eBR (Electronic Batch Record) to efficiently document every step. This speeds up considerably activities in the lab and guarantees compliance with the strictest statutory provisions. In production BioNTech uses an intelligent planning tool SIMATIC IT Preactor to coordinate all the steps. It allows hundreds of different medicines to be produced in parallel in the shortest possible time.  

 

This effectively reaches several important milestones along the road to market approval for personalised medicine. The next step is to confirm the efficacy of such vaccines with larger numbers of probands. 

Cell Collection

Identification of mutations

Manufacture of medicine

Documentation & Quality Assurance

Treatment

Medicine production without SIMATIC IT Preactor

The production process at BioNTech consists of hundreds of individual steps that have to be planned and coordinated very precisely. Without the help of digital systems, this takes up a lot of time – one reason being that variations which occur frequently have to be reacted to accordingly. Planning the production of personalized medicine for hundreds of thousands (let alone millions) of patients by hand would be nothing short of unimaginable.

Documentation without SIMATIC IT eBR

As BioNTech produces one medicine per patient, every drug has to be approved individually. This is subject to strict legal regulations. Every process step must be documented and controlled meticulously. If the data is collected manually, this results in a document of several hundred pages at the end of the process chain which has to be reviewed multiple times before the medicine can be approved.

Medicine production with SIMATIC IT Preactor

Our intelligent planning tool SIMATIC IT Preactor ensures that all resources are maximized throughout the whole production process. It reacts flexibly and immediately to all variations. Only by automating these tasks BioNTech is able to simultaneously produce a large number of differently compounded medicine in the same facility - without wasting time.

Documentation with SIMATIC IT eBR

Instead of drowning in paperwork, BioNTech employees can access all data at any time thanks to SIMATIC IT eBR’s digital documentation capabilities. The software also requests and evaluates all data entries in the correct order. Mistakes are detected and reported immediately. This reduces the time required for documentation immensely.

Cell Collection

Identification of mutations

Medicine production without SIMATIC IT Preactor

The production process at BioNTech consists of hundreds of individual steps that have to be planned and coordinated very precisely. Without the help of digital systems, this takes up a lot of time – one reason being that variations which occur frequently have to be reacted to accordingly. Planning the production of personalized medicine for hundreds of thousands (let alone millions) of patients by hand would be nothing short of unimaginable.

Medicine production with SIMATIC IT Preactor

Our intelligent planning tool SIMATIC IT Preactor ensures that all resources are maximized throughout the whole production process. It reacts flexibly and immediately to all variations. Only by automating these tasks BioNTech is able to simultaneously produce a large number of differently compounded medicine in the same facility - without wasting time.

Manufacture of medicine

Documentation without SIMATIC IT eBR

As BioNTech produces one medicine per patient, every drug has to be approved individually. This is subject to strict legal regulations. Every process step must be documented and controlled meticulously. If the data is collected manually, this results in a document of several hundred pages at the end of the process chain which has to be reviewed multiple times before the medicine can be approved.

Documentation with SIMATIC IT eBR

Instead of drowning in paperwork, BioNTech employees can access all data at any time thanks to SIMATIC IT eBR’s digital documentation capabilities. The software also requests and evaluates all data entries in the correct order. Mistakes are detected and reported immediately. This reduces the time required for documentation immensely.

Documentation & Quality Assurance

Treatment

SIMATIC IT in use

A working day in the digital laboratory

The benefits of digitalised documentation and automated planning have been an integral part of BioNTech's everyday lab activities for some time now. Get an idea of the day-to-day work with SIMATIC IT eBR and Preactor in practice.

Customer references

The same result in one second flat

We have enjoyed an ongoing partnership with BioNTech for over two years now, continually facing new challenges and always overcoming them together. Read what they think about the collaboration and our products.

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Dr. Matthias Miller

Project Manager, BioNTech AG

To offer each and every patient the best possible chance of recovery, we must be able to prepare the vaccine as quickly as possible after their diagnosis. This means that production has to be highly-efficient, fast and economical. Given the extremely promising results from our first trial, we will now run further trials with the aim of producing the vaccine for a large group of patients, proving its effect. I definitely want to remain part of the development.

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Dr. Oliver Hennig

Vice President Operations, BioNTech AG

BioNTech AG is venturing into completely uncharted territory with this product. We need a partner who is flexible enough to incorporate and implement our continuing further developments in the product in a timely manner. A partner who is able to contribute experience and expertise and on whom we can rely 100 percent. We have been working with Siemens on this product for a good two years now. Our partnership, flexibility and joint learning curve have grown over the years. For me personally, I would say that this is the highlight of our project.

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Dr. Kristin Stolpmann

Senior Manager Quality Assurance, BioNTech AG

Two people have to work through approx. 500 pages of documentation to identify and evaluate abnormalities. The Electronic Batch Record software achieves the same result in one second flat, because only alarms, discrepancies and so on are shown in a systematic manner. 

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Dr. Björn-Philipp Kloke

Head of IVAC Technology Platform Engineering, BioNTech AG

Our manufacturing process consists of an extremely large number of individual steps. Discrepancies can occur in each and every one of those steps. If this happens, the manufacture of the vaccine for one patient must not impact the manufacture of the vaccine for another patient. And this is where Preactor helps us: How do we get these patients back on track and where do we continue the manufacturing process? If we did this using paper, it would never work.

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Prof. Dr. Ugur Sahin

Founder and CEO, BioNTech AG

We face two challenges. First, the entire process is a race against time. We have to prepare the tailored medication for the patient in an extremely short space of time. The entire process, from genetic sequencing to identifying mutations to preparing the vaccine, should be as short as possible. The second challenge is that we want to make a customised cancer vaccine for each and every patient. 

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Dr. Felicitas Müller

Head of Biosampling, BioNTech AG

We want to increase patient numbers. So we have to reduce the amount of paper documentation, and this can only be done through digitalization. In the future, we will be able to use barcodes, scan them in and then have the patient identifier in the system itself. This will save us a huge amount of time.

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