Fraunhofer Institute for Cell Therapy and Immunology IZIGMP Biopharmaceuticals
- Development and establishment of analytical methods
- Validation of release-related methods
- Development and validation of potency assays (e.g. ELISA)
- Determination of visible particles according to Ph. Eur. 2.9.20
- Determination of the tightness of rubber stoppers for containers according to Ph. Eur., Chapter 3.2.9 (self-sealing)
- Spectrophotometric quantification and evaluation of the purity of proteins, DNA / RNA
- Measurement of protein stability and aggregation (Prometheus NT.48, NanoTemper Technologies GmbH)
- External order analysis with qualified and audited partner laboratories