Lonza announces successful completion

Basel/Switzerland – Lonza recently has celebrated the completion of a significant upgrade of its Kouřim plant in the Czech Republic (Lonza Biotec s.r.o.). As of now, the facilities are able to produce pharmaceutical enzymes at the highest global cGMP standards and will host the production of Altus Pharmaceuticals’ Altu-135 commercial drug substance enzymes: lipase, protease and amylase. To achieve this important milestone, Lonza built up downstream processing capabilities in filtrations, large scale chromatography, lyophilization and spraydrying in its FDA registered facility in Kouřim. Furthermore Lonza has announced the successful start-up of the Small Scale Plant (SSP) in Nansha Guangzhou, China at the end of September. The Nansha facility, which operates under cGMP conditions, is designed to accommodate a greater number of reactors including a dedicated and technologically advanced Quality Control lab capable of fulfilling the ever increasing requirements of the global regulatory authorities on the highest possible level. In the completed first build-out phase, further smaller reactors including distillation and filtration units are installed, capable of handing a broad range of technologies. The configuration ensures fast change over, optimized efficiencies and extremely rapid technical transfer to commercial assets. Additional capacity can be added without impacting the running operations. The plant is designed for production of quantities from ten kilograms up to several hundreds of kilograms, and closes the gap between Nansha’s kilo lab and commercial production assets to allow complete life-cycle support for pharmaceutical products out of China. The commercial scale API (active pharmaceutical ingredients) facility in Nansha is currently under construction and will go online in the second half of 2008.