Bioassays

At our center of excellence we are ready to effectively perform, develop, optimize and validate standardized or custom-made bioassays to meet your specific needs. In vitro bioassays are used to determine the relative potency of a biopharmaceutical product by comparing its biological activity (related to the in vitro mode of action) to that of a standard preparation. Bioassays are used from preclinical development to batch release and stability testing according to GMP regulations. The bioassays, we offer, are validated according to international guidelines and recommendations (USP, ICH, EMEA & FDA guidelines).

 

Bioassay Readouts

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+49 (0) 7352 9119 -30