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.
