BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Humira bioassays assays to support Humira biosimilar manufacture, process development, characterization and comparability studies. We offer industry leading Humira comparability and Humira characterization services and these can be adapted to suit your Humira material, if necessary.
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 Humira bioassay method that is not listed, please contact us.
The bioassay is the only analytical method that directly measures the biological activity of Humira 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, Humira 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 Humira bioassays:
- Humira TNF-Alpha Neutralisation of cell death (L929/U937 cells)
- Humira TNF-Alpha Neutralisation of apoptosis (U937 cells)
- Humira TNF-Alpha Neutralisation of adhesion molecules (HUVEC cells)
- Humira complement dependent cytotoxicity (CDC)
- Humira antibody dependent cytotoxicity (ADCC)
If you require a Humira bioassay method that is not listed, please contact us.