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  6. New Biopharmaceutical Characterization Service

New Biopharmaceutical Characterization Service

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last updated:Nov 06, 2025

Sartorius Stedim Japan K.K.
Sartorius Stedim Japan K.K.
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Integrated services with expertise and industry leadership.

【Top Service Provider】 The foundation for the approval of new biopharmaceuticals is built on a robust analytical data package that demonstrates the safety, purity, and efficacy of the product. BioOutsource's analytical testing package combines physicochemical and biological analytical methods, allowing for detailed characterization tailored to each client. 【Client Management Organization】 Projects are carried out by cross-departmental teams, and client managers provide support and advice with high transparency throughout the entire lifecycle of the client's project. 【Industry-Leading Integrated Services】 By supporting the development and characterization of biopharmaceuticals from preclinical development to commercialization, we provide services tailored to our clients' needs.

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BSC_Outsource_8856.jpg

New Biopharmaceutical Characterization Service

BSC_Outsource_8856.jpg
BSC_Outsource_8856.jpg
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【Expertise】 ▪ Over 10 years of experience ▪ 99% on-time delivery rate ▪ Scientists with extensive experience and knowledge ▪ Expertise in the development, optimization, and validation of complex potency bioassays and binding assays using cells ▪ Extensive established assays for routine characterization of monoclonal antibodies ▪ Specialized team of protein characterization experts

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catalog(8)

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New biopharmaceutical characterization service

New biopharmaceutical characterization service

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Safety testing and characterization of Chinese hamster ovary (CHO) cell bank.

Safety testing and characterization of Chinese hamster ovary (CHO) cell bank.

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Evaluation of physicochemical and biological equivalence of biosimilars | Assessment of homogeneity

Evaluation of physicochemical and biological equivalence of biosimilars | Assessment of homogeneity

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Cell line development and upstream process services

Cell line development and upstream process services

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Manufacturing and Characterization Analysis of Cell Bank

Manufacturing and Characterization Analysis of Cell Bank

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Safety testing for biological products and viral vaccines.

Safety testing for biological products and viral vaccines.

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4Cell CHO Platform

4Cell CHO Platform

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4Cell CHO CLD Platform (Poster)

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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