Milestones of Boehringer Ingelheim’s Biopharmaceutical Business

Substances with highly specific effect

Biopharmaceuticals are active ingredients that are produced by means of living cells – these can be mammalian cell lines, microorganisms or even plant cells. In contrast to traditional chemical active ingredients biopharmaceuticals are complex, highly molecular proteins that are able to either substitute body’s own proteins (e.g. Insulin or growth hormones) or even attack specific cells like monoclonal antibodies do in the case of cancer cells. Therefore they come with considerably less side effects than chemical substances that spread in the whole organism.

The early bird: Boehringer Ingelheim among the pioneers of biotechnology

For Boehringer Ingelheim the true story of biotechnology production started already in the 1960s when the focus of its research was on chicken interferon. Because Interferon became the most promising treatment of cancer in the 1970s, Boehringer Ingelheim decided to start to genetically engineer this molecule in 1979. Only two years later Boehringer Ingelheim’s Viennese researchers had managed to produce interferon by biopharmaceutical technology. In the mid of the 1980s the first own recombinant interferon was registered in Austria and Germany. This groundbreaking breakthrough in biopharmaceuticals led to the collaboration with Genentech and many other pharmaceutical companies – and further to the foundation of the Research Institute of Molecular Pathology in Vienna.

After the registration of Boehringer Ingelheim’s first biologic on the market in 1983, Boehringer Ingelheim invested into a large scale manufacturing plant for the fermentation of microorganisms in Vienna which started to work in 1985. Berofor and Imukin were the first two products from Boehringer Ingelheim that were manufactured at this plant for the market.

Large scale biotech plants for mammalian cell culture fermentation

The same year 1985, the site of Biberach, Germany saw the rise of a large-scale biotech plant for mammalian cell culture. Six bioreactors with a capacity of 90.000 liters were installed to grow mammalian cells for the production of recombinant proteins and enzymes – such as Actilyse^® that was developed in close cooperation with today’s largest biotech company Roche/Genentech. Being able to effectively dissolve a thrombus, Actilyse^® is used for the treatment of acute myocardial infarctions and especially thromboembolic stroke, a growing indication worldwide. To stay abreast of the growing need, the already large scale facilities in Biberach were again augmented in 2003: Today, 10 additional bioreactors offer a capacity of 220.000 liters.

Visionary planning and innovative thinking pay off

The decision to invest substantially in large scale plants at a time where the biotechnology was still at its beginning proves visionary planning, innovative thinking and entrepreneurial spirit. “At Boehringer Ingelheim we knew that to be one day at the forefront of such an innovative technology the foundation had to be laid long before”, says Prof. Uwe Bücheler (Head of the Biopharmaceuticals Business Unit). Temporary overcapacities in 1990 were transformed into a new business model: contract manufacturing for pharmaceutical industry provides the entire production technology chain from DNA to fill and finish under one roof. Since 1995, Boehringer Ingelheim BioXcellence^™ has helped its customers to bring 27 molecules to market, which is outstanding in this industry.

Worldwide network of production plants

To secure a continued production chain even in times of peaks and to allow a seamless move from one site to another Boehringer Ingelheim has built a worldwide network of production plants. Each site has its core competencies: While Biberach remains the center of excellencefor new market launches with its large scale capacity and bundled experience in cell culture, the site in Vienna is the center of competence for producing in microorganisms with a strong portfolio of market products. Currently, a new production plant is being constructed in Vienna for production in cell culture, offering 500 new jobs by 2021. The site in Fremont, USA, benefits from the technical expertise in neighbored Silicon Valley which pushes new technological developments. A strategic move was made by Boehringer Ingelheim to become a pioneer for China in 2013 as in China still a lot of patients do not yet have access to state of the art Biopharmaceuticals. Recently Boehringer Ingelheim has been awarded by the government to participate in a CMO trial project and inaugurated its Chinese plant in 2017. This site is the first and only biopharmaceutical facility established by a leading multinational biopharmaceutical manufacturer in China utilizing state of the art mammalian cell culture technology.

“The process is the product”

“Biopharmaceuticals are highly complex molecules, which at an industrial scale and with consistent quality can only be manufactured using cell culture technology”. Manufacturing requires substantial experience and know-how as well as state of the art facilities. “This is no commodity business”, says Prof. Uwe Bücheler. “We do apply a highly advanced and automated technology to manufacture these complex molecules in a consistent quality.” For this reason the market is a focused one with few players that offer know-how and long-term experience. “Our customers appreciate to have a partner on eye level with us since we know what it means to develop, manufacture and launch Biopharmaceuticals”. The attempt of new competitors to enter the business won’t shake the solid foundation and the leadership position of Boehringer Ingelheim BioXcellence^™.