Fraunhofer Institute for Cell Therapy and Immunology IZIGMP Cell and Gene Therapy
- Class A (100), B (100), C (10,000), and D (100,000) pharmaceutical clean rooms with a total area of about 650 sqm, modular structure, divided into suites with separate air filtration. We offer altogether 13 class B manufacturing rooms within two separate clean room facilities for handling different kinds of manufacturing projects for cell and gene therapy products. If required the rooms can be operated according to gene technology safety level S2.
- Qualified equipment for the production of cell-based medicinal products, e.g. particle-monitored class II laminar flow workbenches, CO2-incubators (some with oxygen regulation), refrigerated centrifuges, inverse microscopes, controlled rate freezers for the cryopreservation of cells, storage tanks for storing cells in the vapor phase of liquid nitrogen, CliniMACS®-cell separation system, CliniMACS Prodigy® with electroporation unit, MaxCyte GT® Scalable Transfection System, LOVO-Cell Processing System, Sepax S-100-cell separation system, ELUTRA® cell separation system, gentleMACS™ Dissociator for tissue dissociation, TSCD II Sterile Tubing Welder, CR6 Tube sealers, etc.)
- Qualified equipment for the quality control of cell and gene therapy products (e.g. FC500 Navios, BD FACSLyric™, LightCycler realtime-PCR System, Vii7 realtime-PCR System, QX200 Droplet Digital-PCR System, Tecan Sunrise and Tecan Infinite M 1000 PRO ELISA-Reader, Vi-CELL™, Vi-CELL BLU, NucleoCounter® NC-200 device for the automatic determination of cell count and viability, Sysmex XS-800i and XN-350 haematology system)
- Qualified equipment for sterility testing (BacT/Alert® 3 D Dual T-microbial detection system) and testing for bacterial endotoxins (Endosafe® nexgen-PTS™)