Bioassay services for EU release testing
Eurofins’ bioassay laboratory in Munich, Germany, performs testing of approximately 400 batches of client material per year using a diverse range of bioassay types. Batch release testing is performed for both EU and US markets.
For more than 25 years BIOSERVICE Scientific Laboratories (BSL) has provided the scientific and experimental know-how to design and execute tailor-made bioassays in close collaboration with clients from all over the world.
BSL’s expertise in establishing cellular in vitro bioassays and experience in performing non cell-based and in vivo bioassays are available in this sophisticated service.
Development, optimization (using Design of Experiments (DOE)), validation and performance of bioassays/potency assays is US FDA approved and performed according to GMP regulations. Validation strategies are based on clients’ requirements as well as international guidelines and recommendations (e.g. ICH, USP/EP, US FDA and EMA).
In addition to various client-specific assays, the pharmacopeial methods for Erythropoietin [EP], (PEG)-Filgrastim (G-CSF) [EP and USP], Urofollitropin (FSH) [EP], Interferon alpha [EP], Interferon beta [EP] and Insulin [USP] are presently established. With extensive experience in ADCC assays using various target cell labeling techniques and either PBMC or a suitable NK cell line as effector cells, this array of established assays helps clients in the biosimilar industry to expedite their product development and commercialization timeline.
The team of bioassay scientists is aware of the newest trends and discussions in the field due to regular participation at international bioassay conferences and workshops and offers individual advice concerning specific projects with regard to scientific and regulatory requirements.
In addition, the bioassay teams in Munich and Lancaster work closely together to leverage expertise and provide clients with global bioassay capabilities.