Development and manufacturing of biopharmaceutical medicines from mammalian cell culture

Mammalian Cell Culture

The Heritage of our Business

Biopharmaceutical medicines from mammalian cell cultures have a long tradition at Boehringer Ingelheim BioXcellence™. With a track record of currently 16 launched products, a global network with a commercial bioreactor capacity of more than 280,000 L and a broad variety of cell lines and molecules, we are the preferred partner of our customers  for virtually all their needs in cell line development, process development and clinical and commercial supply.

Global Network of Mammalian Cell Culture Experts

Our global production network gives us great flexibility in transferring processes from our customers to our sites, between sites and between scales. In addition, the combination of our stainless-steel bioreactors (capacity from 2,000 L to 15,000 L each) and our fully disposable single-use bioreactor system (capacity from 100 L to 2,000 L) allows us to work at any scale our customers may need. The disposable system is fully integrated into our manufacturing processes and implemented globally at our cell culture sites in Biberach (Germany), Fremont, CA (USA) and Shanghai (China). We also constantly add to our capacity, with the investment in a new large-scale cell culture facility in Vienna, Austria as the next milestone. 

For mammalian cell line development, we take advantage of our High Expression Technology (BI-HEX® CHO-K1), an established high expression technology platform that ensures fast-track development of high-quality, high-titer processes. We use multiple high expression CHO cell lines to produce several mammalian molecule formats and our experience reaches well beyond standard monoclonal antibody (mAb) formats, for example in recombinant proteins and enzymes or multi-specific mAbs. Whether it is formulation, upstream or downstream development:

We have the technology and experience for your cell culture project.

Mammalian Cell Culture at a Glance

  • Experience with Fab fragments, Fc fusion proteins, TandAb, Ig DART, and further complex biologics like bi- or multispecific mAbs
  • Proven experience for all commercially available single-use bioreactor systems including fully disposable downstream
  • cGMP compliant manufacturing
  • Seamless process transfers from our customers and within our network
Proven experience in biopharmaceutical medicines from mammalian cell cultures

BI-HEX® CHO-K1

Take advantage of our established high expression technology platform BI-HEX® CHO-K1 to ensure fast-track development of high-quality and high-titer processes.

Take advantage of our established high expression technology platform BI-HEX® CHO-K1 to ensure fast-track development of high-quality and high-titer processes.

  • Optimized expression vectors with proprietary genetic elements
  • Suspension adapted CHO-K1 host cell line portfolio
  • Improved protein secretion and with different glycoprofiles
  • Proprietary chemically defined media and feed platform and well-characterized downscale models
  • Automation and miniaturization platforms for high throughput screening in cell line and purification development
  • Generation of cell lines in as few as 7 months
  • Amount of produced material sufficient to meet supply requirements for Phase II trials
  • More than 80 BI-HEX® cell line development programs have been completed