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

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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.
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Keywords: CGMP; CHROMATOGRAPHY; CUSTOM MANUFACTURING; EX-PROOF; INTRACELLULAR AND EXTRACELLULAR; LONZA; MICROBIAL BIOPHARMACEUTICALS

Document Type: Research Article

Publication date: January 1, 2005

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  • International Journal for Chemistry and Official Membership Journal of the Swiss Chemical Society (SCS) and its Divisions

    CHIMIA, a scientific journal for chemistry in the broadest sense, is published 10 times a year and covers the interests of a wide and diverse readership. Contributions from all fields of chemistry and related areas are considered for publication in the form of Review Articles and Notes. A characteristic feature of CHIMIA are the thematic issues, each devoted to an area of great current significance.

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