BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Herceptin bioassays to support Herceptin biosimilar manufacture, process development, characterization and similarity studies. We offer industry leading Herceptin comparability and characterization services and these can be adapted to your Herceptin material, if necessary. 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.
The bioassay is the only analytical method that directly measures the biological activity of Herceptin 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, Herceptin 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 Herceptin bioassays:
- Herceptin complement dependent cytotoxicity (CDC) assay
- Herceptin antibody dependent cellular cytotoxicity (ADCC) assay
- Herceptin antibody dependent cellular phagocytosis (ADCP) assay
If you require a Herceptin bioassay method that is not listed, please contact us.