Bioassay GmbH develops, validates and performs biological assays using approved quality control and development processes for chemical and pharmaceutical goods. Bioassay's key services include Biopharma efficacy and potency, safety in Biopharma research and development, and cosmetica / chemical safety. Bioassay maintains cutting-edge in-vitro and in-vivo laboratories at Heidelberg Technology Park, which clients are invited to visit.
Bioassay are experienced in the execution and evaluation of assays for quality control of pharmaceutical APIs. The company develop and test assays using ICH compliant techniques. In addition to developing new technologies, Bioassay can optimise pre-existing assays for new formats and routine operations. Potency assays include:
Growth Factors and Hormones
Bioassay supplies an extensive portfolio of growth factors and hormones for the biopharmaceutical industry. They also run potency assays based on rigorous studies of the European and US pharmacopoeias, applying Good Manufacturing Practice with a daily schedule of batch release and stability testing of drugs and API's. Bioassay's product range encompasses Human Growth Hormone, Follicle Stimulating Hormone, Parathyroid Hormone, Human Chorionic Gonadotropin, Luteinising Hormone, Filgrastim (G-CSF), Interleukins and Erythropoietin.
Antibodies and ADCC
Bioassay perform a range of recognised therapeutic antibody assays under Good Manufacturing Practice. These include Antibody-Drug Conjugates, Adalimumab, Etanercept, Infliximab, Trastuzumab and Rituximab. The company also focusses on cell targeting and specialises in the origination of assays for ADCC (Antibody Dependent Cell mediated Cytotoxicity), which is exhibited by a number of therapeutic antibodies. Antibody Dependent Cell mediated Cytotoxicity assays are available for applications in quality control and development.
Bioassay has developed specialist drug efficacy models for characterising drugs, particularly for biopharmaceuticals such as hormones, monoclonal antibodies and cytokines. The company are experienced in the characterisation of modified biologics such as pegylated compounds and biosimilars. The range of testing methods relating to biopharma efficacy includes neutralising antibody assays, specific cell line development and receptor binding assays based on fluorescence-activated cell sorting.
Since 2002, Bioassay has focussed on biological assays for chemical and pharmaceutical development and quality assurance. The company employs compliant, standardised procedures and flexible structures to meet all client demands, and assigns accomplished project managers to collaborate with a client throughout their project. Contact Bioassay for more information.
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