RHEINCELL operates fully functional in-house clean rooms, laboratories and cell culture facilities, dedicated to the GMP-compliant production and in-depth validation of iPSCs. The clean room area itself comprises several Grade B rooms with Grade A cabinets and a large Grade D laboratory which also hold capacity for in-house manufacturing of iPSC differentiation products under GMP/ATMP conditions. Driven by its core activities and based on its broad expertise, RHEINCELL is able to offer several services around the iPSC workflow.
generation & validation
As part of our core expertise, RHEINCELL offers cellular reprogramming of external donor cells, expansion of reprogrammed cells, and/or validation of iPSCs. Protocols and in-house characterization assays are fully optimized and integrated into our GMP-compliant quality control system.
manipulation of iPSCs
Beyond covering entire workfl ows or full iPSC line validations, we also offer individual assays and services comprising
- - Certified HLA typing and matching to RHEINCELL‘s clinical-grade HLAh iPSC library
- - Certified karyotyping of iPSCs
- - Certified STR genotyping
- - Next-generation gDNA sequencing
- - GMP-compliant quantitative gene expression analysis of iPSCs
- - GMP-compliant immunocytochemical characterization of iPSCs (FACS and IF)
- - GMP-compliant pluripotency assessment of iPSCs via three-germ layer differentiation
- - Custom genetic manipulation of iPSCs (generation of KO and TET-ON cell lines)
- - Custom qPCR analyses
- - Certified sterility testing
- - Certified endotoxin testing
- - Certified mycoplasma testing
Based on our year-long experience in iPSC research, we offer you to partner with RHEINCELL scientists and develop GMP-compliant differentiation protocols and workflows. Depending on the business model RHEINCELL may partially dedicate its clean room capacity to the joint production of GMP/ATMP-grade differentiated cells and tissue.
RHEINCELL’s cryo storage facility is climate-controlled, burglar-proof and equipped with robust and safe vapor-phase liquid nitrogen tanks which are temperature-monitored and connected to a fully operational emergency system. RHEINCELL offers storage space in its highly secured cryo storage facility to customers and partners.