Biosimilars and Their Structural Characterization

摘要

The term "biosimilars" which is widely used in the biopharmaceutical industry, refers to a generic version of a therapeutic protein. Biosimilars are recombinant proteins produced by genetically modified cells and are made to be a copy of the original biotherapeutic reference product or"innovator"and to share quality attributes with the innovator. Unlike small molecule drugs, biotherapeutics are larger and more complex molecules, which are produced by living cells. The selection of the cell type used in the manufacturing process is primarily driven by consideration of post translational modifications (PTMs) that occur to the protein, with glycosylation being the most common and important PTM.Since prokaryotes cells are unable to provide the appropriate glycosylation for their therapeutic effect, animal cells have been the predominant platform of manufacture. The most widely used is the Chinese hamster ovary (CHO), and others include baby hamster kidney (BHK), mouse myeloma (NSO) and hybridoma (SP2-0).