Corporate Magazine 2012 - Boehringer Ingelheim

2 Disposable single use bioreactorwith sensors attached that helpcontrol pH and dissolved oxygenduring cell culture.1 2INNOVATION DRIVERSIN BIOPHARMACEUTICALSInnovation in biopharmaceuticals will not only be driven by newproducts, but by availability of new technologies. Boehringer Ingelheimis well-prepared to deliver innovation in biopharmaceuticals byprovision of innovative products and technologies.INNOVATIVE BIOLOGICSPRODUCTSLooking at the early phase productportfolio, antibodies will continue todominate the biologics market. AlsoScaffolds, antibody fragments andmore complex antibody-derived moleculesare also on the increase. We arewell-prepared to develop and manufacturethese types of molecules andhave conducted more than 30 feasibilitystudies in the scaffold area.Global disposable networkPersonalised medicine will be farmore prominent in future, resultingin smaller quantities of material andleading to flexibility of scale becominga necessity. This is one reason whywe are establishing a global disposablenetwork.Experience with disposable systemsOver the last few years, Biopharmaceuticalshas been gaining experience withdisposables and an extensive experiencedataset has been collated to date.Now we have made a commitment toset up production facilities using disposablesystems for biopharmaceuticalsin both facilities in Biberach, Germany,and in Fremont, USA. Here wewill be able to seamlessly transfer processesas we apply the same technologyat all our sites.Disposable systems – high qualityThe quality standards will remain thesame regardless of whether disposableor stainless steel systems are used. Mediaand buffer solutions come intocontact with the product during theprocess, or even become part of theend product. Thus, studies and riskanalyses are carried out regarding theadsorptive and leachable properties ofthe disposable materials used.We have shown for a large number ofprocesses that the yield, along with theproduct quality and purity of the disposableprocess, match that of a conventionalprocess. In future, it is likelythat disposable systems will be state ofthe art, replacing conventional stainlesssteel-based systems for early clinicalproduction.94 Boehringer Ingelheim annual report 2012