From Single-Use Bags to Total Solutions for the Biopharmaceutical Industry

Bernard Lemaître and Bernard Vallot founded Stedim in Aubagne near Marseille with the ambition to provide an intravenous nutrient supply for patients whose digestive systems had suffered significant damage due to disease or extensive medical treatment. The company's initial focus was on research and development. Together with scientists, Stedim has developed the first complete system for filling and supplying intravenous parenteral nutrition solutions to patients, with special ethylene vinyl acetate (EVA) bags.

Five years after the foundation, the commercial orientation of the company took place. First collaborations with pharmaceutical companies (Pharmacia 1984, Baxter 1986) in the field of total parenteral nutrition underline Stedim's innovation leadership. The company’s single-use bags are characterized by high quality and a special composition. That makes them suitable not only for medical but also for biotechnological applications.

In the early 1990s, Stedim recognized the potential of biotechnology and developed single-use bag systems for the biopharmaceutical industry. These systems replace traditional steel and glass containers. They are not only less expensive and more user-friendly, but also safer since cleaning with chemicals and the risk of cross-contamination are eliminated. For the pharmaceutical industry, single-use solutions represent a technological revolution.

Stedim goes public on the Paris stock exchange. In that year, the company produced bags in sizes ranging from 50 milliliters to 500 liters. The size was continuously increased in the following years to meet the requirements of laboratories and pharmaceutical manufacturers, and by 1996, the maximum capacity had already been doubled to 1,000 liters.

Stedim opens a new plant in Tunisia, complementing production capacities in France and the United States. Focusing on its core business with single-use bag systems, Stedim established itself as an industrial partner to the biopharmaceutical industry. Two years earlier, sales of products for biotechnology exceeded those of products for use in medical fields – the company's historical origins – for the first time.

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With the acquisitions of Integrated Biosystems Inc. (IBI) and Isolateur Dénominateur Commun (IDC), Stedim expands its portfolio and shifts its focus from single bags to integrated bag-systems. IBI, previously a collaboration partner of Stedim, was the global leader in controlled freeze-and-thaw technologies of biopharmaceutical compounds, intermediates, and finished products. IDC has developed aseptic transfer ports that enable reliable transfer of solids or liquids from a non-controlled to a sterile area while ensuring the integrity of the sterility chain.

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Sartorius acquires a majority stake in Stedim S.A., the world market leader in disposable bag systems, and merged its activities with its own Biotechnology Division, which has been particularly active in the fields of filtration, separation, and cell culture technologies. The merger resulted in a leading international partner for biopharmaceutical research and industry. The new Sartorius subgroup, which is listed on the Paris Stock Exchange, bears the name Sartorius Stedim Biotech S.A., and is headquartered in Aubagne, France.

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Thanks to continuous innovation and the acquisition of companies with complementary technologies, Sartorius Stedim Biotech has developed into a leading partner to the biopharmaceutical industry. While the initial focus of acquisitions has been on single-use technologies (automated bioreactors & centrifuges), software solutions and process as well as cell line development, the focus has been expanded in the past years to areas such as chromatography and cell culture media, making the company’s portfolio even more relevant for customers.