BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Enbrel bioassays assays to support Enbrel biosimilar manufacture, process development, characterization and comparability studies.
We offer industry leading Enbrel comparability and Enbrel characterization services and these can be adapted to suit your Enbrel material, if required. We have extensive experience in the development, optimization and validation of custom cell based bioassays to assess the myriad of functions that can be mediated by monoclonal antibodies. If you require a Enbrel bioassay method that is not listed, please contact us.
The bioassay is the only analytical method that directly measures the biological activity of Enbrel 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.”
As with the majority of therapeutic monoclonal antibodies, Enbrel has a number of different mechanisms of action and therefore a range of bioassays are required to measure each of these mechanisms in order to fully characterize the product and demonstrate comparability with the Originator/Innovator material. BioOutsource offers the following Enbrel Bioassays:
- Enbrel TNF-Alpha Neutralisation of cell death (L929/U937 cells)
- Enbrel TNF-Alpha Neutralisation of apoptosis (U937 cells)
- Enbrel TNF-Alpha Neutralisation of adhesion molecules (HUVEC cells)
- Enbrel complement dependent cytotoxicity (CDC)
- Enbrel antibody dependent cytotoxicity (ADCC)
If you require a Enbrel bioassay method that is not listed, please contact us.