We deliver client-focused solutions for the specific testing and manufacturing requirements of your biosimilars. Services include cell bank creation and storage, cell bank characterization, safety testing, process evaluation for viral clearance, product characterization, stability studies, equivalence studies and product release testing.

We also offer bioassays and mass spectrometry services to demonstrate comparability and a full range of services biosimilar development, including toxicology studies to demonstrate biosimilarity, analytical (dose formulation analysis), bioanalytical (toxicokinetics and immunogenicity), immunohistochemistry (e.g., tissue-cross reactivity) and immunology (e.g., flow cytometry and other biomarkers as appropriate).