FlexAct Systems Significantly Ease Seamless Process Transfers within Boehringer Ingelheim’s Manufacturing Network

"The ability to work across different Sites at a global scale with one Boehringer Ingelheim Project team and one Sartorius project team, truly enabled the success of the project."

Jan Feuser, Head of Clinical Supply Facility Downstream

“The multi-operational FlexAct systems enabled complete flexibility and interchangeability throughout our Global Single-Use platform."

– Michael Dieterle, Head of Protein Science, Downstream Development

Quick Info

  • Multiproduct clinical supply facility
  • Process Control System
  • Compatibility with Boehringer Ingelheim standard mAb platform process
  • Maturity of Equipment

Biberach (Germany), Fremont, CA (USA), Shanghai (China)

  • Conceptual, Basic and Detailed Design for DSP
  • Multifunctional FlexAct based on Digital Control Unit (DCU)
  • FlexAct for Media Prep.
  • FlexAct for Virus Inactivation, Virus Removal and Ultra-/Diafiltration

Key Achievements

Conceptual Design for Single-Use Downstream Process

The early involvement of Integrated Solutions bioprocess consultants, facilitated the implementation of a global single-use platform within Boehringer Ingelheim’s manufacturing network.

Implementation of Multifunctional FlexActs

The equipment selected (FlexAct Single-Use systems) provides a flexible solution to cell culture manufacturing needs for buffer preparation, low pH virus inactivation, virus removal and ultrafiltration/diafiltration operations. Those systems could be perfectly integrated into a fully Single-Use and functionally closed platform due to a high degree of standardization.

Enabling global single-use Platform for Boehringer Ingelheim

"The ability to work across different Sites at a global scale with one Boehringer Ingelheim Project team and one Sartorius project team, truly enabled the success of the project."

– Jan Feuser, Head of Clinical Supply Facility Downstream

The implementation of a common DCU control unit

Makes operators familiar with FlexAct Single-Use systems and minimizes training requirements. The system automation reduces operator involvement (LEAN).

Background Information

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquatered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

As a pioneer in biopharmaceuticals with more than 35 years of experience the company has brought more than 20 biologic medicines to patients around the world together with its customers. Boehringer Ingelheim Biopharmaceuticals supplies the Boehringer Ingelheim in-house development pipeline and marketed products e.g. Metalyse®, Actilyse® and Praxbind® as well as the contract manufacturing business, known as Boehringer Ingelheim BioXcellence™. Boehringer Ingelheim Biopharmaceuticals operates four best in-class biopharmaceutical development- and manufacturing facilities in Biberach (Germany), Vienna (Austria), Fremont (USA) and Shanghai (China).

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