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

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.

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

【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.

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.

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

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

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.

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

■ 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.

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

■ 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

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.

【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

【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

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

【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

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.

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.

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

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.

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.

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.

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

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.

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

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).

- 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.

■ 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

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

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.

■ 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.

This application note included in the eBook demonstrates how to gain process insights using screening ensembles. By applying the insights obtained, it enables process optimization without compromising cell quality. 1. Design of multifactor experiments 2. Validation of high-performance media and reagents 3. Characterization analysis of target cells 4. Data analysis for practical insights 5. Utilization of screening platforms for continuous iteration

■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.