A pioneer twice over

Prof. Dr. Dr. Rolf G. Werner is a visionary and pioneer. He established the company’s biopharma site in Biberach, Germany, in the early 1980s and paved the way for its Biopharmaceutical Contract Manufacturing in Europe, the US and China.

In 1983, Rolf G. Werner was trying to convince the company’s management to invest in a pilot facility in Biberach for the manufacturing of biopharmaceuticals – the first of its kind in Europe and at Boehringer Ingelheim. The construction of what was then the world’s newest and largest biotechnology facility cost the equivalent of around 77 million euros – a huge amount at the time. Werner frequently found himself standing at the construction site, worrying “Will it all work out?” The bioreactors represented a bet on the future: Biopharmaceutically produced medicines from cell cultures would provide a breakthrough for diseases that were difficult to treat. But such biopharmaceuticals had not yet been approved in Germany.

Werner acts cautiously and deliberately – he’s a typical Swabian. But when he’s convinced of something, he casts restraint aside. “When it comes to the development of medicines that are intended to eliminate the causes of a disease, genetic engineering is the next logical and rational step.” Werner was convinced of that in the mid-1980s, when he was the project manager for Boehringer Ingelheim’s partnership with Californian biopharmaceuticals company Genentech. In Biberach, Germans and Americans worked together on cell cultures to produce biopharmaceutical active substances. They were breaking new ground within the company. “Back then, Boehringer Ingelheim was a chemical and pharmaceutical company,” says Werner. Things had changed for the company’s chemists now that biotechnologists and genetic engineers also had a seat at the table.

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In any case, the greatest resistance existed outside the plant. “For a long time, the public opposed genetically engineered medicines,” Werner recalls. He visited adult education centers and patiently answered citizens’ anxious questions, of which there were many. “My strongest argument was always the benefit of genetic research for patients,” Werner explains.

Yet that was by no means the end of the difficulties: It was necessary to revise Germany’s genetic engineering act to reflect biopharmaceutical progress. Together with the German chemical industry association (VCI), Werner and his team pushed forward with these changes. In 1990, Germany’s Bundestag resolved a change in the law which created the right framework for biopharmaceuticals.

When it comes to the development of medicines that are intended to eliminate the causes of a disease, genetic engineering is the next logical and rational step.

Prof. Dr. Dr. Rolf G. Werner

They thus laid the foundations for a success story. The 300 team members in Biberach became a business area that has around 4,000 employees at four locations worldwide – and continues to grow. Boehringer Ingelheim has now produced more than 35 different biopharmaceutical medicinal products used by patients around the world.

Yet that is far from the end of Werner’s story. Since the early 1990s, this biopharmaceutics pioneer has pushed forward in a different area: opening up Asia’s markets. He recognized China’s huge potential as a growing world market early on and began establishing relationships there. The former leaders of the federal state of Baden-Württemberg, Lothar Späth and Erwin Teufel, soon appointed him to their advisory boards for the business development activities of German companies in the People’s Republic of China. He began to visit the Middle Kingdom even more frequently and advocated Boehringer Ingelheim’s expansion of its biopharmaceuticals activities to include China.

Boehriner Ingelheim‘s site in Shanghai produces biopharmaceuticals on global standards.

China was very open-minded about new technologies right from the start, Werner remembers. Nonetheless, over time, Boehringer Ingelheim continuously undertook pioneering work in the areas of order development and production. Previously, a marketing authorization holder in China had not been able to commission a third party with the production of a biopharmaceutical medicine. Following a pilot phase, the relevant legislation was revised and contract manufacturing is now provided for by law in China. The first biopharmaceutical commissioned under this new legislation is produced through Boehringer Ingelheim’s contract manufacturing operations in China. It was approved at the end of 2019. Boehringer Ingelheim is also enjoying rapid growth in other fields in China and all of its business areas are present in the country.

In biopharmaceutical contract manufacturing, Boehringer Ingelheim is a step ahead of its competitors in China: It is the first international company to have a biopharmaceuticals site in Shanghai for commercial contract manufacturing based on global standards. Pioneer Werner has naturally already been there to visit the facility – even though he has officially been retired since 2012. Thus, the hard-working Swabian is just not inclined to take things easy.

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