Biosimilars Development & Testing
Improve Patient Access to Life-Saving Drugs for Serious Diseases with Biosimilars
As the leading experts in biosimilars, we understand that demonstrating your biosimilar has fingerprint-like similarity to the reference product is a complex process. With our complete range of testing and development services from biosimilar cell line development, off-the-shelf & custom assays, through to biosafety testing and cell bank manufacturing, and our unrivalled expertise in the field we are your complete solution provider.
Biosimilar Testing Services
Work With the Leading Experts
The focus is on analytics during biosimilar development, with a requirement to demonstrate no clinically meaningful differences between your biosimilar candidate and the reference medicinal product.
Our expert scientists have developed a qualified suite of off-the-shelf fit for purpose assays to fully asses the binding, functional, physicochemical and structural features o your molecule, and they have extensive experience in custom assay development to reduce your time to market by offering packaged testing services to support comparability and characterization of your biosimilar.
Biosimilar Development Services
Biosimilar Cell Line Development
As a manufacturer of a biosimilar, you must develop the cell line. Our CHO (Chinese Hamster Ovary) Expression Platform is the most competitive system available for cell line development. Our expert scientists have devised a strategy to ensure critical quality attributes are taken into consideration from the very beginning of the development cycle. By doing so, we are able to choose the right clones at the clone selection stage to maximize your chances of developing a successful biosimilar. We can analyze your cell line at every stage of the CHO Expression Platform's cycle to assess for comparability to the originator molecule.
Biosimilar Biosafety Testing
Fully cGMP Compliant Services
Fully characterizing your biosimilar is a regulatory requirement. Another is biosafety testing, as required by the FDA (Food and Drug Association) and the EMA (European Medicines Agency) to ensure your product is free of contaminants.
We pride ourselves in being a leading provider of cGMP biosafety testing for biopharmaceutical drugs and vaccines. Offering a comprehensive range of off-the-shelf biosafety assays, including, but not limited to, sterility testing, in vivo and in vitro assays, and genetic stability testing.
Additional Biosimilar Targets
We can perform physicochemical, structural, and binding assays to characterize Zaltrap/Eylea (aflibercept) biosimilars, anti-VEGF therapies.
We also provide primary potency assays that demonstrate functional comparability, alongside assays to confirm the absence of antibody-dependent cellular cytotoxicity (ADCC) for aflibercept.
Yervoy targets cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and acts as a checkpoint inhibitor, activating the immune system by reducing CTLA4-mediated regulation.
Sartorius has ready-to-use physicochemical and structural assays alongside our panel of Fc receptor and C1q binding assays to perform a detailed characterization of your Yervoy biosimilar.
Orencia is a fusion protein targeting CD80/CD86. Our analysis portfolio includes cell- and SPR-based binding assays to characterize your biosimilar’s comparability to the innovator product. We also offer a reporter gene potency assay and a panel of Fc functional assays to demonstrate a lack of ADCC, complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP).
Erbitux is an IgG1 molecule targeting epidermal growth factor receptor (EGFR). Our physicochemical and structural assays are ready-to-use alongside our panel of Fc receptor and C1q binding assays to provide a comprehensive characterization of your biosimilar. In addition, a binding ELISA demonstrates antigen-binding through the Fab region.
Xolair is an IgG1 monoclonal antibody against IgE and is used to treat allergic asthma. We offer an extensive set of physicochemical and structural assays, alongside our panel of Fc receptor and C1q binding assays. An IgE binding ELISA and potency ELISA provide coverage of key critical quality attributes. ADCC and ADCP lack of function assays are also available.
Cosentyx is an IgG1 molecule targeting the pro-inflammatory cytokine IL-17. Sartorius delivers detailed physicochemical and structural alongside our panel of Fc receptor and C1q binding assays to assist in developing your biosimilar.
Tysabri targets the alpha-4 integrin and is used to treat multiple sclerosis and Crohn’s disease. Our analysis platforms generate insights into the physicochemical properties, structural attributes, and binding capabilities of your biosimilar. Our Fc binding platform has also been demonstrated to show the expected binding. In addition, we have developed a range of SPR based alpha-4 integrin binding assays. These assays are also suitable for IgG4 molecules.
Tecentriq and Imfinzi are checkpoint inhibitor drugs targeting PD-L1 and are effective against a range of cancers. Our recent development of assay packages for nivolumab biosimilar characterization created platforms that could also be used for PD-L1-targeting biosimilars. Analytical physicochemical and structural analysis can be performed on these molecules alongside a cell-based binding assay and a reporter gene bioassay.