Comprehensively supporting the early development of biopharmaceuticals on an independent platform.
Physical and Chemical, as well as Biological Equivalence of Biosimilars | Similarity Assessment 【Expertise】 Industry-leading experience with over 12 biosimilar molecules and more than 30 biosimilar development companies 【Speed to Market】 Cost-effective results guaranteed through a comprehensive lineup of ready-made assays for the characterization and equivalence | similarity assessment of biosimilars 【Higher Quality Assurance】 Providing the necessary data for submission at the time of application, backed by exceptional regulatory and industry insights
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**Experience and Achievements** Sartorius supports the evaluation tests of various biosimilar monoclonal antibodies, including the following, through a wide range of methods. Sartorius is with its customers throughout the development of biosimilars. A team of experienced scientists develops characterization methods for molecules that comply with regulatory requirements. This enables comprehensive evaluation of biosimilars against reference products.
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Sartorius Stedim, established in 2007 through the merger of the German company Sartorius, founded in 1870, and the French company Stedim, is a pioneer in "Single-Use Technology (SUT)." As a company capable of providing comprehensive technical support to the pharmaceutical and biotechnology industries, its cutting-edge technology is highly regarded worldwide in the fields of scientific instruments and biotechnology.