Bioassays

BSL BIOSERVICE performs the testing of about 350 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 24 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. In vivo and non cell-based bioassays of biopharmaceuticals are performed on a routine basis as well.

Our development, validation and performance of bioassays / potency assays is US FDA approved and can be performed according to GLP and 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)