Fraunhofer Institute for Cell Therapy and Immunology IZIGMP Biopharmaceuticals
- Modular clean room facility approx. 180 m² clean room area, classified according to EU GMP Guidelines, Annex 1 (clean room classes A, B, C, D)
- Permanent monitoring of the clean room system via a pharmaceutical monitoring system
- Production rooms allow the processing of various process steps (upstream / downstream / bulk / bottling) due to the different cleanroom classes
Qualified equipment for production
- CO2 incubators with integrated rotary shaker
- Positive pressure isolator
- Bioreactors BIOSTAT® RM20|50 and BIOSTAT® STR200
- Various liquid handling devices for media production, upstream and downstream:
- FlexAct® COM
- BioWelder® Total Containment for sterile tube welding
- BioSealer® for sterile tubing separation
- Various pumps (pinch, diaphragm pumps)
- Cleanroom-class transfer ports Biosafe® 110 Monolever Port
- Chromatography unit ÄKTA™ pilot
- Ultra- / Diafiltration unit SARTOFLOW® Advanced
- Semiautomatic filling line (formats: 5 ml, 10 ml, 20 ml)
Qualified equipment for quality control
- NucleoCounter® NC-200 ™ for automatic cell count and viability determination
- ELISA reader Tecan Infinite M1000 PRO
- NanoDrop 2000
- Test device according to the specifications of Ph. Eur. 2.9.20 for the test for particle contamination (visible particles)
- Refrigerators and freezers as well as incubators with temperature recording and monitoring via a monitoring system
- Leak tester according to Ph. Eur. chapter 3.2.9