ROCHE DIAGNOSTICS - Germany

Thanks to the modifications, the GMP production capacities could be upgraded to handle the purification of fermentation residues with a protein concentration of 1-5g/L and volumes as great as 1000 L. The active pharmaceutical ingredients produced from the new purification line are being employed in phase I and II clinical trials.

The buffer preparation tech center consists of three batch tanks for producing the buffers used in the downstream line. The purification process consists of several chromatography and ultrafiltration steps as well as nanofiltration.

The innovative attachment technology of the plastic bags for the buffer posed a special challenge. We needed to find a way of sterilizing the hose ends of the bags, which are opened during attachment.
In order to meet the exceptionally tight delivery schedule, we needed to achieve a high level of completion during preassembly. The Vessel-FATs were completed 5 months and the Skid-FATs were completed 7 months after confirmation of order. The final assembly was done only in 6 weeks caused in accurate construction and installation engineering. Once the final assembly was completed, we and the client joined in putting the plant into operation and the plant was handed over within the agreed time.