Eurofins BioPharma Product Testing Munich performs the testing of about 800 batches of client material per year using a diverse range of bioassay types. Batch release testing is performed for both EU and US market.
For more than 25 years we have provided the scientific and experimental know-how to design and execute tailor-made bioassays in close collaboration with our clients.
Our expertise in establishing and cultivating primary and permanent cell lines as well as the experience we gained from participation in various international round robin trials e.g. under the guidance of the WHO are at your disposal in this sophisticated service.
Our development, optimization, validation and performance of bioassays / potency assays are US FDA approved and are conducted according to GMP regulations.
Validation strategies are based on sponsors´ requirements as well as international guidelines and recommendations (e.g. ICH, US-FDA, ISO, EMEA).
- Development and optimization of tailor-made bioassays (US FDA approved)
- Validation of tailor-made bioassays according to international guidelines and recommendations (e.g. ICH, US-FDA, ISO, EMEA) (US FDA approved)
- Quality Control: Batch release testing and stability testing according to GMP/GLP regulations (US FDA approved)
in vitro / in vivo bioassays
In close cooperation with its partner BSL BIOSERVICE Eurofins offers the following in vitro and in vivo bioassay services:
in vitro Bioassays
- Assay types
- Biological Assay
- Established assays
in vivo Bioassays
- Established pharmacopeial methods
Bioassay service designs
The following Service packages are at your disposal. Of course, all packages can be modified according to your requirements.
- Assay transfer
- Assay optimization
- Assay development
Toxicological lab at Eurofins Biolab
- Pyrogen test according EP - USP - JP
- Biological assay according international pharmacopeias:
- calcitonin assay
- lipasemic assay
- histamine assay
- fibrinolitic activity
For further information please contact us: firstname.lastname@example.org