BioNTech is a next-generation immunotherapy company pioneering the development of therapies for cancer and other serious diseases, as well as vaccines against infectious diseases. The company combines a variety of innovative therapeutic platforms and bioinformatics tools to drive the development of novel biopharmaceuticals. In doing so, the company has unique expertise in mRNA vaccine development. BioNTech's many well-known partners include Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.
Pioneering work in the development of mRNA vaccines
In the course of 2020, it became apparent that BioNTech would succeed in developing a highly effective vaccine for the novel coronavirus, which had only been genetically decoded at the beginning of the year, in a very short time on the basis of its proprietary mRNA technology. The task now was to provide the necessary evidence for regulatory approval. BioNTech succeeded, and on Dec. 21, 2020, the Comirnaty vaccine became the first vaccine against COVID-19 to receive conditional approval from the European Medicines Agency (EMA). In addition to the regulatory approval process, the company, which specializes in research and development, faced the challenge of establishing a production and distribution network spread across several European countries within a very short time.
Corona vaccination: premier league pharmaceutical logistics
At the center of the distribution network should be a -75°C warehouse, unique in Europe, which ensures the intermediate storage of vaccines and precursors as well as the smooth distribution of vaccines in and outside Europe. "Quality, agility and reliability are the prerequisites for taking big steps in new territory in a short space of time. The successful development and distribution of the vaccine depends on partners who work with us in this highly dynamic environment. GUS supports us with a system that meets the high quality requirements of pharmaceutical logistics and at the same time is flexible enough to adapt to the sometimes rapidly changing conditions" (Carsten Habicht, Associate Director Supply Chain Management, Operations, BioNTech). "With GUS at our side, we have found the right software partner for this challenge," continues Habicht.
GUS-OS Suite: Flexible in use for BioNTech
GUS-OS has been in use at BioNTech's main site in Mainz since 2017 in the field of mRNA-based, individualized cancer vaccine candidates. GUS-OS was introduced to map internal logistics processes as part of the establishment of a production facility for clinical trials there. The range of tasks covered by the GUS-OS Suite extends from requirements planning and the provision of components for patient-specific production to the dispatch of cancer vaccine candidates to participating clinics, for example, as part of the ongoing study.
The tasks of the GUS-OS Suite as a WMS in the logistics center for the coronavirus vaccine are similar, but differ significantly in detail due to the special circumstances. One focus here is on scalable incoming goods, picking and cross-docking processes, with which the constantly increasing handling capacity can be realized. This requires integration into the well-known and at the same time heterogeneous production and distribution network. EDI interfaces and data matrix codes in accordance with the GS1 standard are used for data exchange with partners. This also ensures the traceability of the pharmaceutically serialized product units. Another focus is the special requirements of the vaccine, which is valuable in two senses, with regard to handling and storage. BioNTech was able to implement various storage concepts under -75°C conditions. These are subject to regular adjustments due to the ongoing development of the vaccine. The flexibly configurable workflow control of the GUS-OS Suite, which is also used at BioNTech for MDE-supported processes, stands out here in particular. Last but not least, it is important for BioNTech to be able to reliably control deliveries of vaccine batches from the HUB. Since the GUS-OS Suite, as an ERP system for the pharmaceutical industry, has integrated inventory/batch management as standard, such requirements can be met.
"When BioNTech approached us, we were immediately hooked. In light of the pandemic, we were particularly aware of the responsibility of the project. We knew that we had the necessary expertise and the right product. But it makes us very happy that we were able to put our knowledge and software to productive use in such a difficult situation that is relevant to society as a whole, competently, reliably and with the agility required for the time being." Dirk Bingler, CEO of the GUS Group.
