Beschaffung von Laborausstattung einschließlich Service- und Wartungsleistungen für die GMP-konforme Herstellung von CAR-T-Zelltherapeutika und die zugehörige Qualitätskontrolle und Prozessvalidierung

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The subject of the tender is the award of a project contract for the supply, setup, installation, qualification (IQ/OQ), maintenance and technical support of GMP-compliant laboratory equipment, and for the provision of training and knowledge transfer services for setting up and operating the manufacture of medicinal products for novel therapies (Advanced Therapy Medicinal Products, ATMP) within the meaning of Regulation (EC) No 1394/2007, in particular autologous CD19-CAR-T cell products. The procurement includes, among other things, automated closed cell processing platforms, an electroporation/gene transfer unit, cleanroom-suitable workbenches, flow cytometers, and a cartridge-based high-speed cell sorter, a real-time PCR system, a microbiological detection system, an endotoxin detection system, thermomixers, UV/Vis spectrophotometers and a PCR workstation together with the associated consumables and reagents. The detailed scope of services, formulated in a product- and manufacturer-neutral manner—including the functional minimum requirements as well as the training and knowledge transfer building blocks—is set out definitively in Appendix 1 (specifications). Performance of the…

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