Purification of recombinant proteins

Among other things, different lines are installed for manufacturing recombinant proteins. In this concept, the RPP4 plant, which is used for purification of recombinant proteins, is used as an intermediate stage in the up-scale production transfer from a pilot scale to an industrial scale plant for new products. An expansion was carried out in order to facilitate autonomous operation of the RPP4 plant. This comprised different reprocessing processes from isolation to purification for a batch volume of ca. 1300 litres of harvest broth:

• isolation with tanks, disc centrifuge, high-pressure homogeniser, an ultra-filtration and deep-bed filtration unit, chromatography, CIP/SIP unit
• buffer preparation with tanks, bag filling, LAF cubicle and warehouse
• GMP adaptations, e.g. COP/SOP concept of the plants, installation of an IPC (In Process Control) lab
• expansion of the required utilities (ultrapure water, ultrapure steam, heating/cooling systems...)
• expansion of the office and meeting rooms

Sandoz started this project with VTU Engineering as the general planner. Here, the VTU team was entrusted with all key positions in the planning up to the start-up of the plant. The construction phase was controlled decisively through efficient construction management that encompassed all trades and was completed in accordance with the high quality requirements of Sandoz. VTU employees also oversaw the areas of plant qualifications and validation of the automation systems. To do this, project management qualifications were required in addition to the specific expertise. In peak times, the VTU project team consisted of twelve people with particular expertise in the areas of process engineering, GMP compliance, EMSR technology, apparatus technology, pipeline planning, production engineering and biotechnology. This interdisciplinary composition ensured competent consulting for the customer and professional processing of the project in all phases.