Bioassays provide the means to directly assess the fundamental biological activity of Prolia, and as such signify a key component of a product characterization study. Our extensive experience in the development of bioassays for a wide range of monoclonal antibody products supports a broad range of methodologies for the development of bioassays for the assessment of denosumab innovator and biosimilar products.
The bioassay is the only analytical method that directly measures the biological activity of Prolia and therefore represents one of the most important assessments that should be conducted as part of product characterization, lot release and stability programs. The ICH guideline Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products describes the bioassay as:
Assessment of the biological properties constitutes an equally essential step in establishing a complete characterization profile. An important property is the biological activity that describes the specific ability or capacity of a product to achieve a defined biological effect.
BioOutsource offers the following Prolia bioassay:
If you require a Prolia bioassay method that is not listed, please contact us.