Biosimilars

The success of monoclonal antibody dugs (mAbs) has driven an explosion of interest in their biosimilars. Biosimilar manufacturers are becoming more competitive - Being first to market and obtaining approvals for use in a specific region are creating a need for analytical solutions.

The complexity of these molecules and their sensitivity to changes in the manufacturing process creates an increased need for advanced analytical techniques to thoroughly characterize and compare biosimilar versions to originator drugs.

Shimadzu offers advance solutions for characterizing and establishing comparability of biosimilars using powerful liquid chromatography platforms, liquid chromatography mass spectrometry (LC/MS), MALDI-MS and spectroscopy products.

More recently, Shimadzu introduced state-of-the-art LC/MS/MS solution for the comprehensive analysis of cell culture media - so that biosimilar manufacturers can ensure that their media mix is similar to that of the originator manufacturer's media mix.

The innovative nano-technology based nSMOLTM Antibody BA Kit helps to simplify and streamline antibody bioanalysis/PK of biosimilars when using LC/MS.

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