Contacts and Location
|Contact 1||Ēriks Jakobsons|
|Enquire about this equipment|
PSCUH Cell Transplantation centre
The ZRP Cell Cultivation System enables mass expansion of MSCs under conditions suited to generate “Advanced Therapy Medicinal Products” (ATMPs) according to international standards. Key elements of the Key elements of the Key elements of the Key elements of the ZRP Cell ZRP Cell ZRP Cell ZRP Cell Cultivation System Cultivation System Cultivation System Cultivation System are the ZRP GMP Breeder, combining features of a laminar flow workbench and a cell culture incubator, and the ZRP Control Unit for automatic regulation of the parameters of a cell culture process, e.g. pH, pO2, temperature, medium perfusion and medium feeding rate. Different types of ZRP Bioreactors can be operated inside the ZRP GMP Breeder. The ZRP Bioreactors of the H series are of particular advantage when cells with strong contact inhibition have to be expanded (like bone marrow derived MSCs).
The Zellwerk GmbH has developed different size versions of the ZRP Bioreactors of the H series. The Zellwerk GmbH has developed different size versions of the ZRP Bioreactors of the H series. The Bioreactors 3000 H and 8000 H are available as presterilized types equipped with tubes, disposable sensor holders and Luer Lock connectors.These bioreactors are certified as Medical Devices of the group IIA. This makes it easy to start a cultivation run for production of MSCs as ATMPs to be used in cell therapies. We also offer re-usable R&D versions of our bioreactors. The Zellwerk GmbH offers a Regulatory Documentation Package for Integration of the ZRP System into a GMP environment: • Documents with regulatory requirements according to EU, FDA, and ICH standards • Technical description and documentation of the validation of the system • Documents for qualification according to DQ, IQ, OQ and PQ • Documents for quality risk management • Standard operating procedures (SOPs)
CTC provide service of large scale adherenet and nonadherent cell expansion, cultivation of tissue segments (bone, skin, cartilage) for clinical application.
ZellWerk GmbH - Hiper Group
50M, 8000 H, 6000 H R&D, 3000 H