Roche Diagnostics - Germany


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Detail Engineering
Procurement
Erection (Supervision)
Commissioning
Qualification (IQ, OQ)
Chromatographysystem for purification of Erythropoietin - (EKD) | 2003
Project completion time: 18 months
Delivery of a DSP (EKD) purification system. The purification area (Downstream Processing = DSP) is an independent subsystem of the aforementioned biotechnological active pharmaceutical ingredient production.
In purification, the product is isolated and filtered/concentrated from the crude protein solution, which is transferred from the harvesting unit. Purification consists of five chromatography steps (four low pressure chromatography steps and one HPLC purification step), as well as one nanofiltration step for virus removal. The final product is a purified, concentrated bulk product, which is delivered from the production facility in bottled form. The final steps and the filling of application containers with the product take place outside the plant.
Baxter Bioscience - Czech Rep.


