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
