Manufacturing process development of flutiform® started on a very small scale and was progressed through scale-up… and allowed for the smooth transfer to our CMO.
Vectura has the expertise to develop manufacturing processes for pMDI products, ranging in scale from small laboratory, all the way through to commercially relevant scale, offering a seamless transition and transfer out to commercial product manufacturing sites.
Manufacturing process development of Vectura’s flutiform® pMDI product, which we supply to partners Mundipharma and Kyorin, started on a very small scale of about 3kg and was progressed through scale-up to a pre-commercial batch size in our Muttenz pilot scale GMP pMDI filling plant. This allowed for the smooth transfer to our selected contract manufacturing organisation (CMO) in the UK, where the commercial process was successfully implemented and validated. Our CMO has supplied worldwide markets since 2012 without any interruption and is currently performing further upscaling to meet the increasing demands of flutiform®, which is a key source of product supply and royalty revenue for Vectura.