WE UNDERSTAND THE COMPLEXITY OF BIOSIMILARS.
Celerion supports all requirements for biosimilar drug candidates. Our expertise is in proven large molecule and immunogenicity bioanalytical assays.
Biologics, and their biosimilar counterparts are large complex biomolecules produced from living cells; slight changes in the manufacturing processes may lead to subsequent changes in safety and efficacy as compared to the originator molecule.Therefore, special considerations must be given to the development of bioanalytical assays for use in biosimilar testing.
Biosimilar Assay Suites
Biosimilar products require a custom developed group of assays that are tailored to the biosimilar under development. These assays characterize the pharmacokinetics, anti-drug antibody reaction and neutralizing antibody response to this similar but different entity. Celerion offers a tailored group of assays in close consultation with our clients.
Built to measure the biosimilar and innovator, this assay demonstrates bio-comparability between the two. In these assays, the preparation of calibrators (in either innovator or biosimilar) and quality control is necessary.
Immunogenicity Assay Best Practices
Selection of one calibrated curve to be used for both the biosimilar and the reference product is required. Use of the overall data to evaluate the differences between the innovator and the biosimilar, and the impact on safety and efficacy is the goal.
Anti-Drug and Neutralizing Antibody Assays
Celerion offers a tailored group of assays in close consultation with our clients to characterize safety and efficacy.
Contact firstname.lastname@example.org to get our biosimilar package.