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

【Features】 ■ Effective for production: Achieves high cell proliferation and virus production in media with known chemical components ■ Efficient operation: Simplifies filtration and purification in downstream processes, improving virus productivity ■ Safety and regulatory compliance: Reduces variability between processes and minimizes contamination risks

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This is a chemically defined medium developed for the rapid and robust proliferation of MDCK cells for vaccine manufacturing. It provides an environment suitable for MDCK cells for all upstream processes and manufacturing scales. The use of MDCK cells is very useful as it allows for the production of viruses for vaccine manufacturing in a suspension culture system.

• Culture medium
• Other bio-related products and services

Features of the suspended MDCK cell platform: ■ Monoclonal suspended MDCK cells Cells adapted to animal component-free serum-free medium without the use of genetic recombination from ATCC MDCK (NBL-2) CCL-34. ■ 4Cell MDXK CD Medium A chemically defined medium designed for the growth and infection of MDCK cells, free from animal-derived components and proteins. ■ Support Services We provide technical support throughout cell bank testing, safety testing, characterization, upstream and downstream processes, and scale-up.

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NutriCoat Attachment Solution is a cell adhesion substrate designed for human mesenchymal stem cells (hMSC) based on human fibrinogen, suitable for serum-free and xeno-free culture. It is optimized for human MSC derived from various tissues cultured in MSC NutriStem XF Medium. Additionally, it supports long-term culture of hMSC and the results of colony-forming unit-fibroblast (CFU-F) assays under serum-free and xeno-free culture conditions. This product is a ready-to-use solution that can be stored at room temperature, making it ideal for experiments in cell therapy research.

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NutriStem hPSC XF will be registered with the U.S. FDA Drug Master File (DMF)! NutriStem hPSC XF medium is a xeno-free (XF) medium optimized for the culture of human iPS/ES cells. It contains no animal-derived components and is composed entirely of human-derived proteins. NutriStem hPSC XF Medium has the capability to culture human pluripotent cells without the need for high concentrations of bFGF or other stimulatory growth factors or cytokines, enabling long-term culture while maintaining undifferentiated potential under both feeder-free (Matrigel coated) and on-feeder (MEF, HFF) conditions.

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MSC NutriStem XF medium is a xeno-free medium for human mesenchymal stem cells (MSC) derived from various tissues such as bone marrow, fat, and Wharton's jelly. It supports the long-term culture of human MSC while maintaining the fibroblast-like morphology, self-renewal ability, and multipotency observed in normal MSC. MSC Attachment Solution - Xeno-free, purified human fibronectin/fibrinogen - Optimized for serum-free culture - For the proliferation and differentiation of hMSC MSC Dissociation Solution - Ready-to-use, known chemical composition - Recombinant trypsin solution NutriFreez D10 Cryopreservation Solution - Known chemical composition, animal-derived component-free, protein-free - Excellent cell adhesion and viability

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MSCgo Xeno-Free Chondrogenic Differentiation Medium is an innovative xeno-free (free of animal-derived components) and serum-free medium designed to directly induce the differentiation of human mesenchymal stem cells (hMSC) from various sources into chondrocytes. A complete medium is prepared from a basic medium and a supplement mix that includes all the growth factors and supplements necessary for differentiation. Additionally, hMSC isolated and expanded with MSC NutriStemXF can be efficiently induced to differentiate into various cell types (fat, bone, cartilage).

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The cells stored in this solution demonstrate high recovery rates, normal cell characteristics, and excellent performance due to components that provide pH buffer, osmotic support, energy substrates, and ion concentration. ■ Ready-to-use ■ Known chemical composition, free from animal-derived components, serum-free, and protein-free ■ Provides maximum safety during low-temperature storage (2 - 8°C) ■ Ensures high survival and recovery rates after low-temperature storage ■ Ensures the safety of cells during transport ■ Suppresses necrosis and apoptosis after storage ■ Ideal for a wide range of applications ■ DMF preparation in progress ■ Surpasses competitors in the market

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NutriFreez D5 Salt Based Cryopreservation Solution provides an environment that can protect cells even at ultra-low temperatures (-196°C), ensuring high survival rates, recovery rates, and performance for very delicate cells. It is manufactured under current GMP conditions and demonstrates industry-leading performance. This product is optimally formulated, containing 5% DMSO, and does not include antibiotics, antifungals, hormones, growth factors, serum, or proteins.

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NutriFreez D10 freezing preservation medium is a ready-to-use cell freezing solution that is optimized for multiple cell lines, free of animal-derived components, serum-free, and protein-free. When culturing cells in a serum-free environment, it is important to maintain serum-free conditions during cell freezing and preservation. This product has been shown to have high efficiency in cell viability, proliferation, adhesion (in relevant cell lines), and physiological activity/expression even after freezing and thawing. It has demonstrated superior results compared to serum-containing freezing media and other serum-free products, making it an ideal product for both serum-containing and serum-free applications.

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When using cells for large-scale high-quality production, the Sartorius SoloHill microcarriers offer many advantages: ■ Proven track record: Used for over 30 years in the pharmaceutical and healthcare industries for animals and humans. ■ Streamlined solution: Ready to use immediately after sterilization, no prior hydrophilization is required. ■ Ready for immediate use: Sterilized products have a Sterility Assurance Level (SAL) of 10-6, eliminating the need for sterility validation and shortening the manufacturing process.

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You can check the following Sartorius culture solutions from this catalog: ■ Stem cell culture media, supplements, and reagents ■ Immune cell culture media ■ Recombinant human albumin and biopreservation ■ Other media and reagents ■ Growth factors and cytokines ■ HEK293 media portfolio ■ Services

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■ A smooth transition from the early development stage to the clinical stage with consistent quality and performance ■ Optimal cell proliferation and differentiation ensured by excellent batch-to-batch consistency ■ Regulatory support related to GMP products manufactured in compliance with applicable GMP guidelines

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■Efficiency: By adjusting the characteristics of LNP with the library, optimization of in vivo distribution according to therapeutic purposes is achieved. ■Safety: The unique imidazolium structure is protected by a proprietary patent held by Sartorius Polyplus. ■Validated: Concept proof tests (PoC) have been successfully conducted in both in vitro and in vivo settings. ■Flexibility: A highly versatile library that allows for the selection of LipidBrick lipids optimal for each application.

• Other research reagents

Features and Benefits ■ Hydrophobic, forms a monolayer on the water surface, reducing surface adsorption ■ Prevents aggregation and minimizes instability by dispersing uniformly in solution ■ Scavenges free radicals and protects against oxidative stress ■ Functions as a pH buffer and nutrient source, supporting an optimal microenvironment for sustained cell survival ■ Supports cell viability during and after freeze preservation ■ A completely non-human and non-animal derived product, reducing logistical challenges

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■ Time and cost savings Bags can be connected to any mixed system. No testing of raw materials is required. ■ Consistency between batches Buffers comply with cGMP (21CFR820) and are prepared according to customer specifications. ■ Just add water After dissolving, only sterilizing filtration is required.

• Culture medium

Biowelder TC is a fully automated device for connecting thermoplastic tubes through aseptic welding operations. This innovative technology enables aseptic connections of tubes with outer diameters ranging from ¼ inch to 1 inch.

• Other physicochemical equipment

"Biosealer TC" is the latest model in the Biosealer series, which has received high praise from many users. This series has been used in various single-use product applications as a heat sealing machine for tubes compatible with different tube diameters. The latest model features a touch screen, making it even easier to use. We invite you to experience the enhanced operability.

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■Reduction of Risks and Improvement of Performance There is no risk of contamination between batches or products. Mycap bottle closures have passed integrity tests for bacterial immersion. ■One-for-All Closure System All Mycap closure systems are built using the same high-performance platinum-cured silicone seal, regardless of tube material, tube size, port configuration, bottle type, or bottle size. By implementing Mycap throughout the entire manufacturing process, validation becomes easier, and regulatory burdens are reduced. ■Easy Implementation Choosing pre-assembled single-use Mycap bottle closures can reduce the burden of validation and parts management.

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The Takeone sterile sampling device is a key component of an effective microbial control program. Samples collected using Takeone are used to measure purity attributes such as bioburden, sterility, and endotoxin concentration, as well as important process parameters like metabolites, nutrients, osmotic pressure, and pH. ▪ Independent sterile sampling in a closed system ▪ Accurate sampling ▪ Pre-assembled and ready to use ▪ On-demand sample collection ▪ Ergonomically designed for ease of use by operators ▪ Completely single-use, disposable type

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TakeOne Flex is a series of modular sampling solutions designed to meet complex needs such as process monitoring and regulatory compliance.

• Other dispensing equipment

Features and Benefits ■ Simplification of dispensing tasks ■ Rapid preparation of small-scale batch media ■ Elimination of contamination risks ■ Assurance of reproducible dispensing ■ Paperless record management ■ Cost reduction through plug-and-play single-use setup

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■Mixing Force: Rapid powder dissolution or homogenization of high-viscosity products ■Low Shear: Floating impeller supports gentle mixing for delicate products sensitive to shear ■Modular: One Flexsafe Pro Mixer base unit can accommodate three different sizes of bag holders ■Scalable: Wide mixing performance up to 1,000L

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Single-use systems (SUS) are increasingly being used in final filling, vaccine manufacturing, cell therapy, and gene therapy. Regulatory requirements regarding particulate matter are clear for final pharmaceuticals, but they are not clear for SUS used in the upstream processes of final pharmaceuticals. In 2016, Sartorius launched a particle reduction program to reduce uncertainty and minimize the risk of particulate matter contained in SUS being introduced into final pharmaceuticals. As a result of this initiative, the levels of particulate matter in SUS have visibly decreased.

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【Features】 ▪ Unprecedented performance and stable quality supply ▪ Expertise in materials science and film extrusion molding ▪ Management of the entire manufacturing process ▪ Stable quality supply for wetted components ▪ Validation and quality assurance ▪ Assurance of the integrity of single-use systems ▪ Safe and reliable handling and transportation solutions from 5 L to 500 L ▪ Safe, self-deploying robust solutions

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Features and Benefits ■ Special design covering all steps of CGT liquid handling manufacturing from upstream to final filling ■ Excellent biocompatibility and robustness support with Flexsafe film ■ Qualified and flexible design space ■ Support for regulatory compliance

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A high-speed, flexible, and intelligent single-use mixer that accommodates all stirring processes in cGMP-compliant bioprocessing. In mixing processes within the bioprocess environment, quality and efficiency are critically important, and the choice of mixing equipment has a dramatic impact on both. A high-speed, flexible single-use mixer enhances manufacturers' competitiveness and improves productivity.

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Palletank for In-Process Fluid Handling ▪ Easy operation as continuous processes can be performed without moving the container ▪ Easy access from the front door with a double hinge and safety latch ▪ Optimal bag deployment and filling with a lifting system for large containers Palletank for Shipping ▪ Safe and robust liquid transport achieved through ASTM qualification testing of Flexsafe3D bags using Palletank for Shipping ▪ System integrity ensured by compressing and securing Flexsafe l Flexel 3D bags ▪ Removable structure saves space on-site before and after use Palletank for Storage ▪ Qualified system confirmed ▪ Stackable ▪ Technical integration support Plastic Palletank for Storage ▪ Containers made of PP and ABS ▪ Stackable when filled with liquid, foldable when unfilled ▪ Smooth and scratch-resistant plastic surface ▪ Standard product

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Octoplus FF is a sterilized, ready-to-use single-use final filling set that can be configured with various components and connectors. 【Main Features】 ■ High reliability in filling accuracy ■ High drainage rate ■ Enhanced foreign matter control during assembly ■ Lot release testing ■ Clean, sterilized, and 100% integrity tested

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The Biosafe Rapid Transfer Ports (110 mm and 200 mm diameter) are a reliable and user-friendly solution for the safe transfer of materials and liquids, maintaining the integrity of critical areas such as isolators, RABS, and clean rooms. Features and Benefits • Unique magnetic technology without rotation prevents foreign matter generation • Designed to protect the suspicious ring, reducing potential contamination risks • External opening port configuration allows for glove-free operation • Compact and space-saving port fittings for isolators (optional 90° lever available)

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Based on over 15 years of experience in the design of single-use freezing and thawing solutions, we have established Celsius pre-design solutions (PDS) for all processes requiring frozen storage and frozen transport, at both lab scale and manufacturing scale. Celsius PDS separates the downstream process and is equipped with the necessary functions for the safe transport of active pharmaceutical ingredients to pharmaceutical manufacturing facilities.

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Celsius FFT | FFTp with Safecore Technology is a groundbreaking single-use sterilized bag-in-plate design (cassette) that demonstrates excellent performance in the protection of biopharmaceuticals during freezing, storage, handling, and transportation. 【Features and Benefits】 ■ Outstanding protection throughout the entire lifecycle ■ Maximum robustness up to 80°C, inspection and cleaning functions, easy operation, and compatibility with various sterile connectors ■ Flexible and stable freezing and thawing that can accommodate scalable and diverse processes ■ Bulk processes (storage | transportation)

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A robust, complete, and scalable solution for frozen storage and frozen transport. Sartorius offers lab-scale Celsius solutions for smarter and earlier process decisions in the management of frozen active pharmaceutical ingredients. The Celsius Lab-scale Platform enables the characterization of freezing and thawing within single-use bags of 30 mL to 100 mL, featuring complete scalability up to the commercial-scale Celsius Platform (CFT, FFT, and FFTP).

• Other physicochemical equipment
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Sartorius, with over 15 years of experience in the design of freeze-thaw solutions, offers lab-scale and manufacturing-scale solutions for all steps of processes requiring frozen storage and frozen transport. This enables biopharmaceutical manufacturers to effectively decouple downstream processes and safely transport active pharmaceutical ingredients to drug manufacturing facilities. The Celsius Platform, equipped with options for blast freezers, horizontal freezers, and vertical plate freezers, provides an end-to-end integrated approach that enables monitoring and control to broadly ensure product quality and integrity.

• Other physicochemical equipment
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Sartorius offers a wide range of customizable manufacturing standards designed to validate visual inspection processes used in quality assurance to address the challenges of detection through visual inspection. Sartorius's Particle Validation Standards (PVS) provide an economical and straightforward method to solve the time-consuming and complex task of creating standards in-house. They are also effective as training samples for manual inspection systems. ■ Supports reliable and efficient control against foreign matter contamination ■ Responds to customer needs with a wide lineup ■ Validation of visual inspection ■ For training inspectors ■ Economical and straightforward

• Defect Inspection Equipment
• Other physicochemical equipment

Improving the downstream process purification can reduce product costs, which has led to significant interest in enhancing the productivity of downstream processes. In this webinar, we will introduce the features of Sartobind Rapid A, which eliminates the need for affinity resin and achieves a reduction in process time. 【Seminar Overview】 ■ Date: November 21 (Thursday) from 3:00 PM (approximately 20 minutes) ■ Format: Webinar recorded broadcast [Japanese, Free] If you are unable to attend on the day, please register first. A viewing URL will be sent to you later. *We apologize, but participation from other companies in the same industry and email addresses not associated with your organization is not permitted. Thank you for your understanding.

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Liquid Transfer is an essential part of bio-manufacturing processes. For every transfer between different single-use, multi-use or hybrid systems, you will get the right solution for your biopharmaceutical process. With Tuflux Tubing, you benefit from the purest Silicone and TPE tubing for the transfer of your critical fluids. Both tubing types have excellent extractable/leachable profiles and guarantee the highest cleanliness and safety across all process steps.

• Other bio-related products and services
• Other bio-related products