11 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Boehringer Ingelheim has developed and implemented a flexible set-up and operational approach for disposable technologies within its global biopharmaceutical development and manufacturing network.
Regardless of which single-use system has been used by customers, Boehringer Ingelheim's disposable set-up enables different commercially available single-use systems to be operated in the same facility and by the same experts.
Boehringer Ingelheim BioXcellence's customers now benefit from an unprecedented level of flexibility while maintaining reliable and efficient project transfers. Besides the novel 100L and 500L good manufacturing practice (GMP) facilities for clinical material supplies the same set-up is in operation for non-GMP process development.
"We have gathered years of experience from different single-use systems in our expert groups and could therefore form a truly unique single use platform for upstream- and downstream processes", commented Dr Hitto Kaufmann, VP, process science, Germany, Boehringer Ingelheim Biopharmaceuticals.
This platform will be established globally in Boehringer Ingelheim's mammalian facilities and will support clients globally with the same technology as well as quality standards. It will significantly ease seamless process transfers, smooth outsourcing concepts and further boost the firm's new and highly flexible lean-to-clinic program from gene-to-drug product in 16 months.