A team of Boehringer Ingelheim scientists reports another milestone in the development of the BI-HEX® technology platform. A record productivity of more than 100 picogramms per cell per day was achieved in inoculum and fed-batch cultures of BI-HEX® Chinese hamster ovary (CHO) cell lines expressing a therapeutic monoclonal antibody.
At this point the most recent result coming out from the BI-HEX® platform suggests that another leap in productivity is indeed possible. Combining sophisticated vector set-ups with rigorous high-throughput screenings enabling rapid selection of high-producer cell lines under process conditions and the latest version of a Boehringer Ingelheim proprietary media and feed platform led to the generation of cell lines that produce previously unreported amounts of an IgG molecule during inoculum culture and in a scalable fed-batch format.
Boehringer Ingelheim is one of the worlds leading manufacturers for producing therapeutic proteins from mammalian cell culture. As a true one-stop-shop (from the genetic engineering up to the launch of a biopharmaceutical) Boehringer Ingelheims biotechnology site in Biberach/Riss (Germany) offers more than 100.000 liters of GMP cell culture capacity, more than 20 years of process and regulatory experience and its BI-HEX® CHO platform shaping the state-of-the-art of the industry for many years.
The success of therapeutic antibodies produced from mammalian cell culture in the clinic and on the market has fuelled a race to increase cellular productivities for many years with scientists all over the world asking at what point fundamental limits would be reached.
"We are enthusiastic about the new proof that our BI-HEX® technology platform continues to revolutionize the biopharma landscape leading to antibody productivities in industrial relevant CHO processes beyond that magic boundary of 100 picogramms per cell per day," states Professor Rolf Werner, Senior Vice President of the Corporate Division Biopharmaceuticals at Boehringer Ingelheim.
"We are particularly encouraged by this result, as we obtained the data without any cell-line specific process optimization", adds Dr. Lore Florin who is leading a team of scientists reporting the new record productivities.
Boehringer Ingelheim will continue to develop BI-HEX® and expects further improvements to be reported in the near future.
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.