Corporate Magazine 2012 - Boehringer Ingelheim

our businessesperspectives for better health431, 3 + 4 With its new equipment and laboratories inprocess development, Boehringer Ingelheimprovides an expanded service offering for itscustomers along the whole biopharmaceuticalprocess chain. Process science laboratories inVienna, Austria.New processes and technologiesHigh production costs and technicaldifficulties in large-scale productionled to sophisticated technological developmentsand improvements. Thisfledgling area of biopharmaceuticalswill also in future be shaped by innovativetechnology developments infuture.Since production titers for standardmonoclonal antibodies (mAbs) are goingbeyond 4 g/l, which is pushing chromatographybeyond its physical and economiclimits, we are working on columnfreeprocesses. In addition, the generationof new molecule formats and non-mAbproteins cause problems in capturingwith standard affinity materials.In column-free processes, large amountsof protein are manageable and all kindsof biomolecules are feasible as thisprocess technique is mainly independentof protein design. Automation will alsoplay a significant role in this area.DATA-DRIVEN DRUGDEVELOPMENTThrough our automation in all areas ofchemistry, manufacturing and controls(CMC) development, we are able tobetter understand the processes.High throughput and miniaturisedassay provide the data to drive earlydecisions, which have a significantimpact on cost and timelines. Thisnow allows us to gain a holistic viewof biopharmaceutical processes earlyon. The process knowledge is basedon a much broader data set and allowsearly decisions to be made onthe right molecule format.The realisation of a new purificationplatform process from pre-harvest tobulk is the goal based on approved technologiessuch as aqueous two phase extraction(ATPE) and controlled precipitationand filtration processes.Innovation drivers in biopharmaceuticals95