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

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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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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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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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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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 extend our heartfelt 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 our new product, the Pillow Packaging Full Air Tightness Inspection Machine MSQ-2003. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to visit us at this opportunity. 【 Exhibition Name 】 JAPAN PACK 2025 Japan Packaging Industry Exhibition https://www.japanpack.jp/ 【 Dates 】 October 7 (Tuesday) to October 10 (Friday), 2025 *4 days 10:00 AM to 5:00 PM 【 Venue / Booth Number 】 Tokyo Big Sight / East Hall 8, Booth 8-505

Sanei Hitec Co., Ltd. will exhibit at SENSOR EXPO JAPAN 2025, which will be held from September 10 (Wednesday) to September 12 (Friday), 2025. At this Sensor EXPO 2025, we will showcase our semiconductor design technology and high-performance IP (Intellectual Property) that support the evolution of sensors.

Sanei Hightex Co., Ltd. will exhibit at the "Student Formula Japan Championship 2025" at the Shizuoka Prefecture booth in Aichi Sky Expo Exhibition Halls E and F from September 11 to 13, 2025.

We would like to inform you that we will be exhibiting our products at the 63rd Annual Meeting of the Biophysical Society of Japan. If you are planning to attend, please be sure to stop by. ❚ Products to be Exhibited - Auto Patch Clamp System | Port-a-Patch mini This compact system eliminates the need for a microscope, vibration isolation table, manipulator, and Faraday cage, which are typically required for conventional patch clamp experiments. It does not require specialized skills or experience, allowing for easy data acquisition and verification. - Artificial Lipid Bilayer Experiment Device | Orbit mini This device allows for easy measurement of channel activity at the single-molecule level. It enables the formation of lipid membranes, reconstitution of membrane proteins, and single-channel measurements using only a micropipette in experiments utilizing artificial lipid bilayers, facilitating functional and structural analysis of target membrane proteins and evaluation of drug effects. - Liposome Preparation Device | Vesicle Prep Pro This is the world's first device capable of producing giant unilamellar vesicles (GUVs) with diameters ranging from 1 to 30 μm without the use of organic solvents, utilizing the electroporation method (vibrating hydrated lipid films in an alternating electric field).

The success or failure of an AI project depends on the quality and immediacy of the "data infrastructure." By combining no-code and low-code products, it is possible to achieve a seamless process from data collection to integration and AI utilization, efficiently building a data infrastructure that supplies high-quality data to AI. We will explain specific methods for flexibly and quickly constructing a data infrastructure, incorporating case studies and demos, and introduce key points of a data strategy to lead to successful AI utilization.