BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Simponi bioassays to support golimumab biosimilar manufacture, process development, characterization and comparability studies. We have extensive experience in the development, optimization and qualification of custom cell-based bioassays to assess the numerous of functions that can be mediated by monoclonal antibodies.
The bioassay is the only analytical method that directly measures the biological activity of Simponi 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 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, Simponi has a number of different mechanisms of action and therefore a range of bioassays are required to measure each of these mechanisms to fully characterize the product and demonstrate comparability with the Originator/Innovator material. BioOutsource offers the following Simponi bioassays:
- Simponi TNF-Alpha Neutralisation of Cell Death (L929 cells)
- Simponi Complement Dependent Cytotoxicity (CDC)
- Simponi Antibody Dependent Cytotoxicity (ADCC)
If you require a Simponi bioassay method that is not listed, please contact us.