BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Avastin bioassays assays to support Avastin biosimilar manufacture, process development, characterization and similarity studies. We offer industry leading Avastin comparability and Avastin characterization services and these can be adapted for your Avastin material if required. We have extensive experience in the development, optimization and qualification/validation of custom cell based bioassays to assess the myriad of functions that can be mediated by monoclonal antibodies. If you require a Avastin bioassay method that is not listed, please contact us.
The bioassay is the only analytical method that directly measures the biological activity of Avastin 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, Avastin 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 currently offers the following Avastin bioassays:
- Avastin VEGF Neutralisation Bioassay
- Avastin complement dependent cytotoxicity (CDC)
- Avastin antibody dependent cytotoxicity (ADCC)
If you require a Avastin bioassay method that is not listed, please contact us.