Why Teva is Investing Over One Billion Dollars in Biologics in Europe
With demand for biopharmaceutical products on the rise, Teva is investing in biologics production technologies for Active Pharmaceutical Ingredients (APIs) with cells for biosimilars and novel biologics. We meet Teva teams on the ground in the biologics manufacturing and supply operations site in Ulm to find out more.
A robust pipeline of biosimilars and novel biologic products is being developed in several therapeutic areas at Teva and will be delivered to patients in the coming years. Biotech products currently on the market are produced in Teva’s biologics manufacturing facilities in Ulm, Germany and Vilnius, Lithuania, and by external companies in Asia and the USA.
To grow in-house biotech manufacturing capabilities and ensure greater supply reliability for customers and patients, Teva has invested in expanding its biologics campus in Ulm, which represents an investment of more than one billion US dollars.
The Important Role of Bioreactors in Biotech Production
The most important equipment in biotechnological production are bioreactors. According to Tamara Ostertag, Project Manager for Biologics Ulm, "Bioreactors are basically a vessel in which our genetically modified cells have the best conditions for producing our APIs. The bioreactor ensures that these cells proliferate and produce our products which can be biosimilars or new biological entities (NBEs). Important parameters for the fermentation of cells in the bioreactors include temperature, pH, oxygen content, nutrients and other factors.”
After the fermentation, which is the first step of biotechnological production, the produced API or “drug substance” is purified via different purification steps such as chromatography or filtration.
In the existing biologics facility in Ulm, stainless steel bioreactors are used for the continuous fermentation of cells, and have been in use since the building was constructed in 2006. “The ‘BioSUB2000’ project involves integrating a new production line into our existing biotech building which will be used exclusively for the production of biosimilars," says Tamara.
“The qualification for the project is in the last steps and will be completed quite soon,” says Stefan Fuegenschuh, Site General Manager, Biologics Ulm.
Genesis: Large-Scale Production of Antibodies
If the capacity of the new line is not able to meet the demands of the biosimilar market for single products, the production lines of the new “Genesis” building may be used. “Genesis” is the second project ongoing in Ulm and includes two independent production lines using stainless steel bioreactors for the production of biopharmaceuticals, mainly antibodies.
On one of the two stainless steel production lines, colleagues will produce an antibody for the treatment of migraine. “We are currently in the middle of the qualification phase, which means highly intensive testing of all equipment” says Stefan.
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NPS-ALL-NP-00787 MARCH 2023
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This content represents the opinions of the contributors and does not necessarily reflect those of Teva Pharmaceuticals. All content is aspirational in nature, is intended for informational and educational purposes, and should not be considered for any product recommendations. Consult a qualified medical professional for diagnosis and before beginning or changing any treatment regimen.