BPMSS – Lonza's Biopharmaceutical Small Scale Plant Started cGMP Manufacturing in September 2004

Abstract

In September 2004 Lonza (Visp, Switzerland) started operations in a new state of the art facility for cGMP manufacture of injectable grade microbially derived biopharmaceuticals. Both intracellular and secreted products can be processed in the new production line, which delivers bulk drug substances. cGMP conformity, including clean room classification, was cross-checked during the design phase with the Swiss regulatory authorities. The layout of the highly automated multi-product line is based on a high performance 1000 l bioreactor suitable for high cell density fermentation. Besides standard chromatography and ultrafiltration, the ex-proof design in upstream and downstream areas allows for solvent feeds in fermentation and for implementation of HPLC purification steps in protein and peptide purification.

Keywords

• Cgmp
• Chromatography
• Custom manufacturing
• Ex-proof
• Intracellular and extracellular
• Lonza