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  6. Evaluation of physicochemical and biological equivalence of biosimilars.

Evaluation of physicochemical and biological equivalence of biosimilars.

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last updated:Nov 06, 2025

Sartorius Stedim Japan K.K.
Sartorius Stedim Japan K.K.
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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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Evaluation of physicochemical and biological equivalence of biosimilars.

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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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4Cell CHO Platform

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4Cell CHO CLD Platform (Poster)

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[Sending recorded video] Cellca Cell Line Development Technical Update: 9 weeks until RCB

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Registration for this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. At Sartorius, we have been providing CHO cell line development services that serve as the foundation for the manufacturing of antibody and protein therapeutics. Two products developed through this service have already been launched, and over 40 molecules are currently in clinical development. This webinar will be divided into two parts to introduce this service. In Part 1, we will present the technical upgrades of this service. In Part 2, we will introduce the media products and related services that have been optimized for this service and are now available for general sale. [Seminar Overview] April 6, 2023 (Thursday) 15:00 (approximately 50 minutes) Webinar recorded broadcast [Japanese, free] *We sincerely apologize, but participation from companies in the same industry and email addresses other than those of your organization is not permitted. Thank you for your understanding.

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[Sending Recorded Video] Services Offered by Sartorius - Introduction to Cell Line Development, Cell Banking, and Various Tests.

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Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. There is a growing need to obtain CHO cell lines with high expression levels in as short a time as possible for the development and manufacturing of protein drugs such as antibody therapeutics. Sartorius' Cellca cell line development service has developed over 140 CHO cell lines to date, which are used for commercial or clinical trial manufacturing. In this webinar, we will introduce the technical background, service formats (contract and licensing), as well as the characterization tests and safety tests for antibody drugs, protein drugs, and various cells (gene and cell therapy, vaccines, etc.). *We sincerely apologize, but participation from email addresses other than those of your company or organization is not permitted. Thank you for your understanding.

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Sartorius

Sartorius Stedim Japan K.K.

Pharmaceuticals and Biotechnology

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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.

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