Successful Start-up of new Biotech Plant in Visp
Lonza Group has commissioned a new cGMP-compliant facility for the production of microbially derived biopharmaceuticals at its largest worldwide production center in Visp (Switzerland). Following the completion of construction and successful qualification and validation, commercial production activities commenced in mid-September 2004.
The single-train facility, which has a working fermentation volume of 1,000 liters, has been designed with flexibility in mind, and as such can easily be adapted to multi product requirements. The heart of the installation consists of a 1,000 liter bioreactor plus primary product recovery and protein purification facilities. The installation is equipped to handle products secreted by microorganisms as well as intracellular products. It is also suitable for culturing microorganisms that require organic solvents. Essential items of infrastructure, such as ultra pure water and ultra pure steam supplies, have been expanded, and supporting functions such as quality management, quality control and research & development have also been extended. The facility meets the requirements of both the US and European regulatory authorities for the production of biotherapeutics and will enable Lonza to supply customers with products for all clinical phases as well as for commercial requirements.
In addition, Lonza AG recently filed an application for the modification of its establishment license, issued by Swissmedic. The modification will enable the manufacture of recombinant vaccines by fermentation.
By expanding its biotech capabilities, Lonza is responding to increasing customer demands for microbially-produced biopharmaceuticals. The investment of over 30 million Swiss Francs underscores Lonza's strategic commitment to being a preeminent supplier to the life sciences industry.
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