ザルトリウス・ステディム・ジャパン List of Products and Services

【Features】 ▪ Reduction of labor time and costs for CIP (Clean-in-Place), buffer storage, and cleaning validation through a single-use solution ▪ Robust and reliable process control with intuitive Process Step Editor control software, calibrated single-use sensors, high-performance diaphragm pumps, and a unique pinch valve block ▪ Shortened time required between batches with user-optimized system architecture and easy-to-install flow kits

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Product Information The Resolute AutoPak column is designed for large-scale pilot and production use. It is available in all common sizes with an inner diameter (ID) ranging from 350 mm to 2,000 mm. This column features the well-established Resolute wet flow path, which achieves low pressure drop and high-resolution chromatography across a wide range of flow rates. The typical flow rate range is from 30 to 800 cm/h.

• Chromatography
• Column Chromatography

The Resolute column has an excellent track record in various chromatography resins and chromatography modes, including ion exchange, mixed mode, affinity, and hydroxyapatite. ■ Achieves optimal efficiency, capacity, and peak symmetry through a high-separation flow path ■ Provides all column functions necessary for filling, discharging, and operating the column within a closed system via a central nozzle valve ■ Reduces validation work during scale-up with an excellent filling method for scalability and reproducibility ■ Column design with an inner diameter of 280 to 1200 mm (up to 2000 mm available upon request) ■ Optimizes process economics with a design that minimizes filling frequency and buffer usage ■ Option to choose between manual or remote-operated nozzle valves

• centrifuge

The "Ambr250 Perfusion" is a fully automated multi-parallel bioreactor system that uses single-use culture vessels of 100-250 mL to accelerate the development of scalable perfusion processes. This system allows for the simultaneous execution of up to 24 different perfusion cultures while returning cells to the culture vessel using hollow fibers, which are commonly reported specifications. This system transforms the perfusion processes that could not be achieved with multi-parallel or small-scale setups, reducing experimental costs with small volumes and accelerating the optimization of high-density cell culture processes. 【Features】 ■ Increased productivity / Reduced experimental costs ■ Simultaneous parallel fed-batch and perfusion cultures are also possible ■ Exceptional scalability ■ Sampling and reagent addition are performed by a fully automated liquid handler, reducing daily working hours *For more details, please refer to the PDF document or feel free to contact us.

• Other physicochemical equipment

The Resolute Linear chromatography column is designed for large-scale pilot production and mass production applications, offering a full range of common sizes with inner diameters (ID) from 350 mm to 2000 mm. It employs a proven Resolute fluid path, achieving low pressure loss and high-resolution chromatography across a wide range of typical operating flow rates. The typical flow rate is 30 to 800 cm/h. The Resolute Linear column range uniquely combines active multi-axis piston control, high-precision linear actuation, and fully automated operation, providing the following advantages: ■ Fully automated, reliable, and efficient filling ■ Reduction of operator workload and errors ■ Operation with excellent safety, cleanliness, and low noise ■ Savings on additional equipment and cleanroom space ■ Configurable to accommodate a wide range of processes

• Separation device

**Features and Benefits** ■ High Throughput: Clarification and/or purification of culture samples ranging from 2.4 × 10 ± 5 mL within 2 hours. ■ All-in-One System: Executes a controlled, simplified, reproducible, and streamlined clarification and purification process in one step. ■ Automation: Achieves time savings and reduction of FTE (full-time equivalent) with a fully automated device equipped with integrated error recovery features.

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The Ambr1515 Generation 2 is a high-throughput "automated micro-scale bioreactor system" that reproduces the performance of laboratory-scale bioreactors. The system consists of single-use vessels, an automated workstation, and enhanced convenience software. It is designed to be installed in a standard biosafety cabinet for aseptic operations, allowing for parallel monitoring and control of 24 or 48 micro-bioreactor cultures. As the manufacturing processes for biopharmaceuticals become more complex and the density of cultures increases, scientists around the world are facing an unprecedented challenge in developing "clone, medium, and process" that meet new demands. The Ambr15 Generation 2 system enhances equipment performance that influences the success of cultures, improves flexibility, and incorporates new features that reflect user feedback. It helps address the aforementioned challenges and supports the acceleration of research by scientists.

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You can find the following information in this catalog: ▪ System specifications ▪ Compatible at-line analyzers ▪ Expandable options ▪ Accessories ▪ Ambr 15 microbioreactor (culture vessel) ▪ Plates and chips

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• Other physicochemical equipment

The industry-standard multi-channel, compact fully automated bioreactor, Ambr250 in a benchtop configuration, has arrived with new features and applications for regenerative medicine. It allows for independent cultivation with highly controlled single-use containers with operating capacities of 100-250 mL, arranged in a maximum of 8 channels. There are three types of containers, each specialized for cells, microorganisms, and regenerative medicine, with a refined design that contributes to process development and optimization. Since the containers are single-use and sterilized, they enable fast turnover, accelerating customers' research and development activities. Because it is geometrically identical to bioreactors used for production scale in pharmaceuticals and regenerative medicine products, it is possible to quickly transition and implement optimized cultivation and production conditions.

• Other physicochemical equipment

The Ambr 250 High Throughput Generation 2 is a multi-parallel bioreactor system that accelerates process development and characterization analysis schedules to achieve cost reduction. Its fully continuous gas supply system realizes similarity with large-scale bioreactors and optimizes the scale-down model. Through the integration of analysis options such as the capacitance-based BioPAT Viamass, it supports extensive feedback control.

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• Culture Equipment
• Bioreactor

The "Ambr250" is a new bioreactor system for parallel operations of microbial or cell cultures using single-use bioreactors with a capacity of 100 to 250 mL, controlled by an automated liquid handling platform. This system was developed in collaboration with two major pharmaceutical companies, based on the micro bioreactor technology held by Sartorius Stedim's TAP division. It supports the necessary culture conditions required for microbial cultivation and mammalian cell culture, which demand advanced technology, as well as applications that require larger sample collections. 【Features】 ■ Individual control of all process parameters ■ Improved operating environment ■ Efficient and rapid miniaturization system ■ Equipped for scalability to benchtop bioreactors ■ Capable of screening a wide range of culture conditions and strains or cell lines *For more details, please refer to the PDF document or feel free to contact us.

• Other physicochemical equipment

The "Ambr15 Generation2" is a high-throughput automated micro-scale bioreactor system that replicates the performance of laboratory-scale bioreactors. The system consists of single-use vessels, an automated workstation, and user-friendly software. It is designed to be installed in standard biosafety cabinets for aseptic operations, allowing for parallel monitoring and control of 24 or 48 micro-bioreactor cultures. 【Features】 ■ Reduces operator time and increases work efficiency ■ Facilitates the process of determining the best clone ■ Enables faster and more accurate operations ■ Capable of complex liquid mixing and addition for multifactorial experimental designs (DoE) ■ Used in research facilities worldwide *For more details, please refer to the PDF document or feel free to contact us.

• Other physicochemical equipment

One device for everything! Univessel Glass is our platform culture vessel that can be used with all Biostat benchtop bioreactors. You can choose from capacities of 1 L, 2 L, 5 L, and 10 L. Thanks to the new design and compatibility with the old version, any existing probes, dip tubes, spargers, or impellers can be adapted to fit this new Univessel Glass.

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■ Design considering efficiency in the SUTFF application ■ Automation supporting advanced operations ■ Rapid exchange and cleanability of single-use flow kits maximize efficiency per batch

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▪ Proven scalable design Reduction of time and effort for process development, optimization, and validation ▪ Compatibility with existing bioreactor controllers Making existing bioreactor controllers more user-friendly with single-use culture vessels employing cutting-edge technology ▪ Interchangeable with existing glass containers Facilitating peak usage relief and efficient schedule management ▪ Single-use from container to sensor Enabling more cultures with current equipment

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Biostat RM has been renewed with a new control tower that adopts the automation platform Biobrain, which is suitable for commercial production using a shaking-type bioreactor. 【Features】 ▪ Accelerates the market launch of customer products ▪ Simple transition from process development to commercial production ▪ Flexible specifications for diverse manufacturing needs and culture styles ▪ High-precision process control ▪ Support system by technical personnel stationed in various countries

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Key Features: ▪ Supports consistent cell growth with the industry-leading Flexsafe RM TX film, known for its reliability ▪ Reduces contamination risk through a closed system ▪ Significantly improves cell recovery yield with a unique gravity harvest ▪ Achieves unmanned monitoring and control of cell culture, including online biomass measurement, through an advanced automation system ▪ Achieves optimal cell growth with a well-established rocking platform

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【Advantages】 ▪ Specifications designed to accommodate all microbial culture processes ▪ Production of plasmid DNA ▪ Microbial culture bags that have undergone qualification for GMP manufacturing ▪ Improved productivity and user-friendly ▪ Refined process control proven in cell culture

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"Biostat B" is a benchtop bioreactor equipped with a control tower that possesses multi-talented capabilities to meet the diverse and varied needs of our customers. It offers a multitude of possibilities by combining three types of culture vessels with proven performance in single and twin configurations. With thousands of units delivered in over 50 countries worldwide, our extensive experience and collaboration with customers globally support this track record. [Features] ■ A bioreactor with proven performance worldwide ■ Custom-made devices can be produced to meet customer specifications using our unique design system ■ Established high quality *For more details, please refer to the PDF document or feel free to contact us.

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The Biostat B-DCU is a fermenter | bioreactor designed to meet various requirements for process optimization and characterization, particularly in the biotechnology and biopharmaceutical industries. It serves as an optimal scale-down model for large-scale production, offering advanced features and an unparalleled range of options for cell culture and microbial culture processes.

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The "Biostat STR Series" is a single-use bioreactor system designed for rapid process development and seamless scale-up to commercial production. The newly launched third generation features a new automation platform, "BIOBRAIN," and the analytical tool "BioPAT(R)," enabling exceptional speed, quality, and productivity. Stable and predictable processes greatly contribute to providing safe and reliable biopharmaceuticals to patients worldwide, accelerating our customers' manufacturing operations and business.

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One of the most essential parameters for customers in the cell culture process is biomass (live cell count). Understanding the fluctuations in live cell count during the culture process leads to deeper insights and understanding of the process. This allows for the control of feed, harvest, and infection timing in accordance with these fluctuations. BioPAT Viamass is fully integrated into standard culture control systems and is the first standard online biomass measurement solution for single-use culture systems, compatible with single-use culture bags such as Flexsafe RM.

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【Advantages】 ▪ Real-time online monitoring of bioprocess parameters ▪ Glucose and lactic acid ▪ Methanol or ethanol ▪ Enabling automatic parameter supply | Air intake control capability ▪ Compact space-saving design ▪ Biosensors provide stable performance at room temperature ▪ Linearity over a wide measurement range

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■ Focus on important matters ■ Quick overview ■ Process safety ■ Advanced charting ■ Calculation functions ■ Complete process control ■ Data integrity and security ■ Regulatory compliance

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BioPAT(R) Spectro is a product specifically developed for Quality by Design (QbD). By generating more process data using this product, the potential of Raman spectroscopy can be maximized. This enables the construction of very robust processes, resulting in the production of consistently high-quality products.

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The introduction of superior Design of Experiments (DOE) solutions enables further reduction in product time-to-market. MODDE, the innovative DOE solution from Sartorius Stedim Data Analytics, supports the interpretation of results through its user-friendly graphic interface and data analysis assistance features. **Features of MODDE** MODDE is a solution that goes beyond mere DOE software. It provides high-quality analyses for decision-making while monitoring risks by alerting to critical settings, leading to more robust conclusions. - Reduction in the number of required experiments - Guidance features for experimental design - Reliable data handling - Support for better decision-making - Integration with existing systems - Achievement of quality goals

• Analytical Equipment and Devices
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Overview of SIMCA-Online ▪ Remote prediction monitoring ▪ Root cause analysis ▪ Prediction of final quality characteristics ▪ Soft sensing ▪ Real-time monitoring and control

• Business Intelligence and Data Analysis
• project management
• Other information systems

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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SIMCA enables the integration and analysis of diverse data sources, helping to identify and understand hidden data that holds the key to business success, and supports decision-making based on that understanding. 【Areas of SIMCA】 SIMCA can be utilized in any environment where data is generated, contributing to the growth of businesses across various industries. ▪ Bioprocess companies: Achieved a 75% improvement in process yield, a 40% reduction in cycle time, and tripled plant productivity. ▪ Global food processing companies: Solved logistics challenges, reducing transportation costs by $1 million annually. ▪ Wastewater treatment companies: Achieved a cleaner and safer environment through process improvements.

• Analytical Equipment and Devices
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Process Intensification (PI) is a comprehensive framework aimed at maximizing overall production volume across manufacturing units, manufacturing processes, or biopharmaceutical facilities. Sartorius Stedim offers scalable and versatile modular solutions, including high-throughput process development tools. These can be implemented in current and future manufacturing facilities for a variety of upstream and downstream PI scenarios. - Enables faster drug development - Improves efficiency and productivity in GMP manufacturing - Applicable to various processes regardless of the pharmaceutical ◆ International Webinar [Process Intensification Webinar Series] This webinar series provides a comprehensive guide to maximizing process intensification. It covers upstream and downstream strategies, media management, data analysis, and more. You can watch it here: ⇒ https://bit.ly/3ihwdT1

• Other physicochemical equipment

Design compatible with safety cabinets Realizes dispensing in a sterile environment that meets GMP requirements. Supports the creation of cell banks and the preparation of frozen samples, allowing for the opening and closing of frozen tube caps and dispensing to be completed in approximately 1-2 minutes. 【Applications】 Fill-It can be utilized in various bioprocess applications as listed below. ■ Creation of master cell banks and working cell banks ■ Dispensing of reference samples (monoclonal antibodies, recombinant proteins, vaccines, etc.) ■ Cell bank creation for drug discovery research (assays, screening, optimization research, basic research) ■ Strain banking during biopharmaceutical development processes/research and development ■ Strain banking for various bio-industries such as the food industry and biofuels

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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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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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【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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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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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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■ A wide range of products to accelerate media development ■ Sartorius' global manufacturing network that ensures supply ■ 100% known chemical composition, animal component-free, serum-free, and free of hydrolysates with high reproducibility ■ In addition to ready-to-use catalog products, customizable and highly flexible ■ Highly filterable and soluble media and feeds

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You can check the following from this catalog: ■ 4Cell CHO Platform: Integrated service package from DNA to cell banking ■ Client management ■ Protein characterization analysis testing services ■ Biosimilar testing ■ GMP cell banking ■ Cell banking services ■ GMP cell bank characterization analysis ■ Package for cell banking & testing services

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The starter kit for the culture system "4Cell XtraCHO" includes all the necessary culture components for cell acclimatization and fed-batch culture at a 3L capacity. When progressing to larger-scale cultures, all individual culture components are available in various forms, both liquid and powder. Using production media and feed media offers benefits such as "eliminating process variability and contamination risks." 【Customer Benefits】 ■ Production Efficiency: Ideal efficiency from bench scale to manufacturing scale ■ Compliance with Regulatory Guidelines: Eliminates process variability and contamination risks ■ Reduces Process Complexity: Facilitates purification *For more details, please refer to the PDF materials or feel free to contact us.

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Selecting the appropriate combination of culture media and feeds for cells, and further optimizing process parameters, is a complex and time-consuming process. Sartorius's extensive portfolio of media and micro-bioreactors that allow for parallel cultivation support optimal and scalable process development for cells. This application note introduces the process optimization of CHO cell culture using Sartorius media, Ambr15, and the experimental design software MODDE.

• Culture medium
• Culture Equipment
• Software (middle, driver, security, etc.)

■ 4Cell CHO Platform - We provide a comprehensive solution of services and media for pharmaceutical development companies seeking stable clones that are easy to scale up in compliance with GMP manufacturing. ■ CHO Media and Feed - Sartorius offers a wide variety of media and feeds to enable pharmaceutical development companies to use optimal compositions for stable clones. This supports high-performance cell growth and productivity, facilitating the transition to clinical stages. ■ Media Services - Media optimization services, custom media development, and manufacturing services.

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- Subsequent adaptation services from cell lines to suspension cell lines - Initial process screening and comparative testing, process development - Media optimization services based on existing catalog media compositions - Development of new media compositions from scratch tailored to process performance indicators using advanced data analysis (MODDE & SIMCA software) - Support for iterative, flexible, and agile approaches with cutting-edge culture and analytical methods and equipment, including the Ambr system.

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【Product Features】 ▪ Uses the highest quality raw materials ▪ Known chemical composition ▪ No adaptation needed from other serum-free media, or minimal adaptation work ▪ Free from animal-derived substances, serum-free, and free from hydrolysates ▪ Manufactured in facilities compliant with ISO 9001 and ISO 13485

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【Features】 ▪ Completely known chemical composition ▪ No adaptation from other media or minimal adaptation work required ▪ Stable culture with seed train cultivation ▪ Robust and high performance ▪ For suspension cells ▪ This sample kit (CFV3FB4000) is for research purposes only ▪ Manufacturing use is also possible upon request

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Cell-based immunotherapy is at the forefront of cancer treatment. The most common type of cell-based immunotherapy to date is T-cell therapy (with CAR-T and TIL being the mainstream). The cells used in immunotherapy are generally cultured in a medium supplemented with human serum. The use of serum introduces variability in the process due to individual differences among donors, leading to inconsistencies in cell growth and characteristics. By removing this serum and simplifying the process, regulatory risks are reduced, and the associated logistical burdens are alleviated. Nutri-T eliminates the need for serum by replacing its essential components with specific proteins, lipids, and other small molecules. <Product Overview> ■ Xeno-free ■ Serum-free, no serum supplementation required ■ Compliant with ISO13408 ■ For research use only ■ Developed using cells from actual cancer patients ■ Excellent results with PBMC, TIL, and CAR-T ■ Outstanding results at low initial seeding density

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