Boehringer Ingelheim: From Mind to Market Our Services in Biopharmaceutical Contract Development and Manufacturing

Evelyn Schmucker

July 1, 2008

2 Min Read

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The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology.

Boehringer ingelheim is one of the leading companies for industrial customer manufacturing of biopharmaceuticals by offering the entire production technology chain in development and production at its biopharmaceutical facilities in Biberach (Germany) and in vienna (Austria).

The large-scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody mimetics, and plasmid DNA. The Biberach site is specialized in highly efficient mammalian cell culture systems with yields well above industry standard in animal component free media. The site in Austria offers high-yield bacteria and yeast processes. In the plasmid DNA manufacturing area Boehringer Ingelheim in Austria has set the standard with yields of 2.4 g/L and supplies early to late-stage clinical trials with gene-therapeutics and DNA vaccines for its international clients.

Boehringer Ingelheim’s Services Include Mammalian Cell Culture

  • Proprietary high-yield expression system BI-HEX® for monoclonal antibodies and glycosylated proteins

  • Fast-track approach:

    • time-to-clinic

    • time-to-market

  • Scale-Up: 80-15,000 L

  • Overall production capacity: 180,000 L

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Microorganisms and Yeast Fermentation

  • Technology platform for therapeutic proteins, antibody fragments, protein scaffolds, gene therapeutics, and DNA vaccines in E. coli and yeast (P. pastoris, H. polymorpha, and S. cerevisiae).

  • Proprietary high-yield plasmid DNA production process

  • Scale-Up: 30-6,000 L

  • Overall production capacity: 13,000 L

Downstream Processing:

  • State-of-the-art downstream processing systems are matched to the scale of production capacity

    • explosion-proof area

    • refolding

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Formulation and Fill-Finish

  • Formulation development

  • Up to 100,000 vials per batch aseptic filling and lyophilization

  • Up to 100,000 prefilled syringes per batch

  • Franchise technologies such as liquid or slow release formulations and inhalation devices

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