The team of BSL BIOSERVICE performs the testing of approximately 450 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 BSL BIOSERVICE has provided the scientific and experimental know-how to design and execute custom bioassays in close collaboration with its global clients. BSLs expertise in establishing cellular in vitro bioassays and experience in performing non cell-based and in vivo bioassays is at your disposal in this sophisticated service.
In addition to various Sponsor specific assays the pharmacopeial methods for Erythropoietin (EPO), (PEG)-Filgrastim/Filgrastim (G-CSF), Urofollitropin (FSH), Interferon alpha, Interferon beta and Insulin are currently established.
BSLs development, optimisation (using Design of Experiments [DOE]), validation and performance of bioassays/potency assays are US FDA approved and are conducted according to GMP regulations.
Validation strategies are based on Sponsor’s requirements as well as on international regulatory guidelines and recommendations (e.g. ICH, US-FDA, ISO, EMA, USP/EP).
Regarding ADCC assays BSL BIOSERVICE offers broad expertise with different target cell labeling techniques and cultivation of a suitable NK effector cell line.