ROCHE DIAGNOSTICS - Germany


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Detail Engineering
Procurement
Erection (Supervision)
Commissioning (Support)
Qualification (IQ, OQ)
Biologics IV Downstream - (B4D) | 2007
Project completion time: 24 months
Vogelbusch Biopharma was contracted to provide two downstream facilities for the new Biologics IV biotechnological production facility. This plant purifies the active pharmaceutical ingredient trastumzumab (monoclonal antibody, trade name Herceptin®).
The process consists of several chromatography and ultrafiltration steps, as well as nanofiltration and deep bed filtration. To cover the media needs, several dilution/mixing stations (buffer/pure water) were installed rather than a standard buffer storage facility.
In order to stay within the extremely tight mandatory schedule for assembly, a high level of completeness was achieved during preassembly. After client acceptance, the plant was moved to the construction site on flat bed trailers and put into operation jointly with the client.


