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 conclusion of a project contract for the delivery, setup, installation, qualification (IQ/OQ), maintenance and technical support of GMP-compliant laboratory equipment as well as the provision of training and knowledge transfer services for the establishment and operation of the manufacture of 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 others, automated, closed cell processing platforms, an electroporation/gene transfer unit, cleanroom-compatible workbenches, flow cytometers as well as 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 PCR workstations along with associated consumables and reagents. The detailed, product- and manufacturer-neutral scope of services – including the functional minimum requirements as well as the training and knowledge transfer components – is finally set out in Annex 1 (specification). The service provision is planned for the period from 19.10.2026 to…

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