Open AccessBPMSS – Lonza's Biopharmaceutical Small Scale Plant Started cGMP Manufacturing in September 2004
Author(s) -
Frans W. J. M. M. Hoeks,
Diego R. Schmidhalter,
Rainer Gloeckler,
Christoph Herwig,
Karen Theriault,
Sven Frie,
Wouter Van den Broek,
Frank Laukel
Publication year - 2005
Publication title -
chimia
Language(s) - English
Resource type - Journals
eISSN - 2673-2424
pISSN - 0009-4293
DOI - 10.2533/000942905777676993
Subject(s) - biopharmaceutical , ultrafiltration (renal) , fermentation , bioreactor , downstream processing , chromatography , scale up , pilot plant , process engineering , chemistry , pulp and paper industry , microbiology and biotechnology , food science , engineering , waste management , biology , physics , organic chemistry , classical mechanics
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.