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

Using Cellca cell line development, over 120 projects have been successfully completed.

Zaltrius is a top provider of cell line development services. It offers cost-effective and highly reliable technology platforms. Cellca cell line development consistently delivers clones for stable research cells that have undergone sufficient characterization. From DNA to research cell banks (RCB) in just 14 weeks, it achieves a minimum monoclonal antibody titer of 5g/L with a scalable fed-batch process.

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Conducted safety and characterization analysis tests on over 200 Chinese hamster ovary (CHO) cell bank samples.

CHO cells are the most widely used production cell lines in the pharmaceutical industry, and their safety profile has been established for over 20 years. Guidelines for the safety and characterization analysis of CHO production cell lines are harmonized with the International Conference on Harmonisation (ICH) Q5 (R1) "Virus Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin" and ICH Q5D "Derivation, Characterization, and Production of Cell Lines for the Manufacture of Biological Products (Biotechnology-derived Products | Biologically-derived Products)." Since 2007, Sartorius has conducted safety and characterization testing for over 200 Chinese Hamster Ovary (CHO) cell bank samples. Our researchers possess extensive knowledge and experience and will provide advice on optimal and cost-effective testing strategies that comply with chemical and regulatory requirements. We will also consider the history of the cell lines and raw materials used during bank manufacturing when proposing test packages.

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Introducing comprehensive solutions for safety testing of biological products and viral vaccines.

All biological products must undergo rigorous safety testing at both the development and manufacturing stages to confirm the characteristics of the product and host cells, as well as to ensure non-contamination. ▪ Exceptional technical expertise ▪ Rapid result delivery ▪ Extensive regulatory knowledge ▪ Enhanced quality assurance

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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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Next-generation GMP cell banking

Thorough characterization and documentation of similar master cell banks (MCB) and working cell banks (WCB) are crucial elements that lead to risk reduction and ensure the safety and product quality of all biologically derived products. An experienced team is leveraging CRO expertise to expand services such as cell bank manufacturing. ▪ Manufacturing in a closed system ▪ Quality assurance ▪ Integration into cell line development and biosafety services ▪ For your applications: from mAbs to vaccines

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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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We would like to express our congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will introduce a number of products, including new ones. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to attend this event. 【 Exhibition Name 】 31st Measurement and Measurement Exhibition INTERMEASURE 2024 Official Website: https://intermeasure.org/itms2024/ 【 Dates 】 From __ (Wednesday) to __ (Friday), 202_ 【 Venue 】 Tokyo Big Sight (Tokyo International Conference Center) East Hall (Booth Number: ___) 【 Exhibited Products 】 - Air Leak Tester - Hydrogen Leak Detector - Pin Hole (Reference Test Piece) and more. For more details, please refer to the "Related Materials" (PDF file) below.

Nitto Kohki will exhibit at the "H₂ & FC EXPO Spring International Hydrogen and Fuel Cell Exhibition" held at Tokyo Big Sight, West Exhibition Hall 2, from February 28 (Wednesday) to March 1 (Friday), 2024. [Booth Number: W14-63] The quick fluid coupling "Coupler" is a product that allows for the rapid connection and disconnection of piping for various fluids such as air, water, oil, and chemical solutions. At this exhibition, we will primarily showcase the high-pressure hydrogen filling quick fluid coupling "HHV Coupler."

☆☆☆ Urgent Visit to Japan & Emergency Event Announcement ☆☆☆ Dr. Yuval Levy, CEO of ISCFDC and developer of EPPIC, who has been involved in CFD research at NASA Ames Research Center for about five years, is coming to Japan! He will demonstrate and explain advanced CFD technologies, application cases, and the latest features of EPPIC himself. □ Date and Time □ July 31, 2026 (Friday) 13:00-18:00 (Registration starts at 12:30) <Part 1: Post-Processor Session> 13:00-16:40 <Part 2: Pre-Processor Session> 16:50-17:50 <Networking Event> 18:10-19:40 □ For more details □ Visit the Hulinks page https://www.hulinks.co.jp/seminar/eppic/

[Viewer Benefits Available] Explaining Tips for LC in a Short Seminar Do you have concerns such as "I'm unsure about column selection," "I'm struggling to optimize analysis conditions," or "I have challenges analyzing compounds with weak retention" in LC analysis? Waters will hold a seminar titled "Must-Listen! Advanced LC Application Seminar" where you can learn practical LC analysis know-how in just 30 minutes. In this seminar, we will cover useful topics in a total of six sessions, including tips for choosing detectors, how to utilize reverse phase columns, scaling up to preparative LC, approaches for analyzing hydrophilic and highly polar compounds, case studies of low-adsorption HPLC, and improving purity through solid-phase extraction. Each session is scheduled to start at 15:00. Event Themes: • October 6 (Tuesday) - Session 1: Tips for Choosing Detectors • October 13 (Tuesday) - Session 2: Tips for Choosing Columns • October 21 (Wednesday) - Session 3: Tips for Preparative LC • October 27 (Tuesday) - Session 4: Approaches for Analyzing Hydrophilic and Highly Polar Compounds • November 5 (Tuesday) - Session 5: Case Studies of Low-Adsorption HPLC • November 10 (Tuesday) - Session 6: Tips for Solid-Phase Extraction

In liquid biopsy research, we will introduce a technical evaluation of proteome analysis to obtain reliable data from trace plasma, as well as case studies on data quality verification using the Contamination Index and Simple Western.