BIPSO GmbH, based in Singen, Germany, has been manufacturing contrast agents for applications in modern medical diagnostics since 2011. BIPSO is part of the Bracco Imaging Group, which is one of the world’s leading specialists in the diagnostic imaging business, and produces imaging agents mainly for Bracco’s sales organisations. The company has recently invested in the expansion of its manufacturing site in Singen with the goal of consolidating its leading position both now and in the future.
Modern diagnostic imaging is an important part of everyday medical practice. Examination techniques such as X-ray, magnetic resonance imaging and ultrasound enable the reliable and accurate detection of pathological changes and injuries in the body. However, it is often difficult to discern organs and blood vessels from the surrounding tissue. “Contrast agents that absorb X-rays more strongly than the structure being examined are used and help distinguish between different structures in the body on X-rays,” explains Dr. Simone Dahlmanns, managing director of BIPSO GmbH.
BIPSO GmbH produces a variety of contrast agents for use in diagnostic imaging. Different imaging agents are used for different examinations. X-ray and computed tomography (CD) examinations involve the use of water-soluble, iodine-containing substances that are injected into the blood circulation or directly into the organ of interest. Magnetic resonance imaging (MRI) requires contrast agents that contain gadolinium. “Both substance classes improve the visibility of an organ under investigation by enhancing the contrast of structures or fluids within the body. X-ray examinations use substances that absorb X-rays more strongly than tissue, while MRI contrast agents enhance signals in the vicinity of the contrast agent,” says Dahlmanns.
Medical contrast agents are considered medicinal products by the regulatory authorities and are therefore subject to strict regulatory requirements that are equivalent to those of therapeutic drugs. “As a result, their production is rather complex and sophisticated. Contrast agents are injected into the human body and must therefore be sterile and manufactured under germ-free conditions,” explains Dahlmanns. Germ-free conditions are generated by supplying high-quality air through special filters, by regularly disinfecting the manufacturing areas and by making sure that people working in those areas are wearing protective clothing. “Our products are manufactured in compliance with FDA standards, which is mandatory for products that are sold on the international market,” says Dahlmanns.
BIPSO, which is the acronym of Bracco Imaging Pharmaceutical Sterile Operations GmbH, belongs to the Italian Bracco Group. Bracco is a pioneer in the production of ultrasound contrast agents and one of the world’s leading manufacturers and suppliers of contrast agents in general. Bracco holds a share of around 52 percent of the global X-ray contrast agent market and the company’s clients are based in more than 90 countries. BIPSO GmbH is the group’s most important sterile manufacturing site, producing and packaging more than 250,000 contrast agent bottles, ampules and vials every day. “Our contrast agents are gold standard products for use with any diagnostic imaging method. This means that they are unrivalled and have long been standard in hospitals and doctoral practices around the world,” says Dahlmanns.
In order to consolidate its position as one of the leading contrast agent manufacturers worldwide, Bracco will invest considerable sums in BIPSO in the coming years. Around 15 million euros will be invested into modernizing the company’s manufacturing facilities with the goal of doubling the current production capacities by 2017. “We will establish a new filling line and a new packing line as well as all ancillary plants that are required,” says Dahlmanns.
Despite the large volume of work involved in the production of contrast agents for Bracco organisations, BIPSO also produces and packages sterile drugs as contract manufacturer for other companies in the pharmaceutical industry. “We are still producing and packaging sterile products for Takeda,” explains Dahlmanns. The two companies have a special relationship as BIPSO GmbH was established in 2011 following the business transfer from Takeda to Bracco Imaging. Bracco used to commission Takeda (formerly Nycomed, Altana and Byk Gulden) to produce and package products. The major goal of this transfer was to make the company independent from other companies. “Bracco established BIPSO with the goal of establishing its own competence centre for the production and packaging of Bracco contrast agents,” says Dahlmanns. The transfer of the business to BIPSO enabled Bracco to make use of the know-how and the infrastructure that existed at Takeda’s production facility in Singen, including an entire production building, an administration building and more than 200 employees. In addition, the shift from contract manufacturing to in-house production helps the company save on costs, protect manufacturer know-how and gives it greater flexibility in terms of production capacities, enabling the company to quickly react to changing market conditions and giving it an important competitive advantage.
The fact that the establishment of BIPSO has paid off is also reflected in current investments and the expansion of the company, which now employs around 300 people. In order to have enough experts for this challenging work in the future, BIPSO offers apprenticeship training positions for pharmaceutical production technicians and industrial mechanics at its Singen manufacturing site. “We also offer internships for students as well as the possibility of doing a thesis or dissertation,” says Dahlmanns.
Further information:BIPSO GmbHRobert-Gerwig-Str. 478224 SingenTel.: +49 (0)7731 - 7909 - 0E-mail: infobipso(at)bracco.comLisa Jung, Assistant to the Management BoardE-mail: Lisa.Jung(at)bracco.com
On November 1, 2015, the BIPSO GmbH management has changed: new managing director is Mr. Michael Isele. Additional managing director is Matteo Bertolini. Mrs. Dahlmanns is no longer active in the company.