BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range off-the-shelf Actemra (tocilizumab) bioassays assays to support Actemra biosimilar manufacture, process development, characterization and comparability studies. We offer industry leading Actemra comparability and Actemra characterization services and these can be adapted to suit your Actemra biosimilar material, if necessary.
We have extensive experience in the development, optimization and validation of custom cell based bioassays to assess the diversity of functions that can be mediated by monoclonal antibodies. If you require an Actemra bioassay method that is not listed, please contact us.
The bioassay is the only analytical method that directly measures the biological activity of Actemra 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 Actemra bioassays:
- Actemra Classical (cis-) Signalling IL-6R Neutralisation Bioassay
- Actemra Trans-Signalling IL-6R Neutralisation Bioassay
If you require an Actemra bioassay method that is not listed, please contact us.