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

Climate Change Measures: How efficient manufacturing strategies impact the climate Water Use Efficiency: How single-use equipment can significantly reduce water consumption Materials and Circularity: The importance of understanding a product's environmental footprint and how to promote circularity Partnerships: Industry associations that Sartorius collaborates with to achieve transformation both within and outside the industry

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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

• Culture medium
• Culture Equipment
• Other Analysis

The Virus Counter platform is an advanced analytical tool that combines the Virus Counter device, dedicated software, and Virotag reagents. It enables rapid and accurate virus quantification. By utilizing flow virometry, it achieves near real-time virus counting, supporting virus-based applications such as the manufacturing of vaccines and gene therapy products.

• Other analytical and testing equipment
• Analytical Equipment
• Other Analysis

Virosart virus filters provide industry-leading solutions in the field of virus removal, ensuring protection and efficiency in biopharmaceutical manufacturing. Virosart meets diverse process needs and enables consistently stable and effective virus filtration.

• Protein Purification Equipment
• Filtration Filter
• Other purification and extraction

By using Sartorius's pre-filter, which has a high capacity and excellent clarification performance, significant cost reductions and optimization of process flow can be achieved. Utilizing our wide range of pre-filtration solutions enhances the product lifecycle of downstream unit operations.

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You can view this as a guideline for selecting the optimal filter.

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■ Sartocon (Flat Membrane Cassette) A high-performance filter optimized for the biopharmaceutical industry, featuring excellent hydrophilicity and broad chemical compatibility. ■ Hollow Fiber (Hollow Fiber) Available in three formats: single-use, autoclavable, and alkaline-cleanable, each providing excellent performance and characteristics to meet various applications and needs. ■ TFF System (Multi | Single Use) Offers tangential flow filtration (TFF) systems at various scales, from lab and process development to clinical trials and commercial production batches.

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This is a free small-scale test to select the optimal types and sizes of final filters and pre-filters for the "filtration" that the customer will implement. The test will be conducted by experienced application specialists in accordance with the customer's filtration process conditions. Tests based on rich experience ensure reliability and guarantee the credibility of the data. Filtration characteristic tests offer various benefits to customers, such as improved workability and cost reduction. Customers with the following needs are encouraged to consider this test: ■ Selection of the optimal filter for chemical solutions ■ Downsizing of filters ■ Functional evaluation of various filter membranes ■ Extension of filter life ■ Increased flow rate ■ Improved product recovery rate

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We support the resolution of issues such as capacity, flow rate, and yield by providing cutting-edge filtration and sterilization filters, while also promoting the acceleration of process development through process optimization services.

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The Zaltcheck series is the most widely used in the pharmaceutical industry and has gained the trust of many users as a proven integrity testing device. The Zaltcheck 5 Plus is the latest model in the series, released in 2019. With new technology, we have further enhanced usability, compliance with the latest regulations, and error detection capabilities. It sets a new standard for integrity testing devices that meets the needs of customers seeking higher levels of testing. 【Main Features of the Product】 ■ Specifications that exceed QRM legal requirements - Automatic detection of test setting errors and abnormal test conditions ■ Highest level of data integrity - Customized Linux OS - Data encryption and dual data backup ■ Intuitive and excellent operability - Large touchscreen with a clear viewing angle and intuitive user interface - First in the series to support Japanese display ■ Achievement of Health, Safety, and Environment (HSE) - Explosion-proof specifications (ATEX IECEx & FM certified) that allow safe testing of alcohol-wetted filters *For more details, please contact us or download the PDF materials.

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■ Detailed condition examination is possible It is possible to examine important parameters regarding the behavior of molecules in the early stages of downstream process development. ■ Automated parallel testing Up to 16 channels can be managed at one control station. ■ Minimal process volume Membrane area of 10 cm² | Small-scale screening with a recirculation volume of 5 mL.

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【Features】 ■ Excellent flexibility ■ Compatible with membrane areas ranging from 50 cm² to approximately 0.14 m² ■ Intuitive and user-friendly operation ■ Adopts the same operational design and sequence as the Sartoflow Advanced system ■ Maximum product yield ■ Low shear 4-piston diaphragm pump

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■Continuous Dialysis Filtration: Realizing Innovation The Sartocon SP cassette evolves traditional dialysis filtration into a single-pass system. ■Versatile System for Process Control It allows for the rapid establishment of process-specific parameters for continuous dialysis filtration. ■Intuitive Control Software With touch screen operation, complete and simple parameter control, and automation, it enables process control with constant TMP or constant feed flow rate.

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This system is ideal for flexible use in lab environments aimed at process development and clinical trials, as well as for small-scale manufacturing batches. With several standard options available, you can obtain the optimal system and make adjustments that perfectly match the individual needs of each customer.

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- The BioStat RM is a single-use rocking bioreactor that is fully compliant with GMP. < BioStat RM 20 | 50 Basic > The BioStat RM 20 | 50 Basic is a standalone bioreactor that is the ideal size for benchtop use. < BioStat RM 200 > The BioStat B and RM 200 Rocker are single-use rocking bioreactors designed for large-scale applications. - The Flexsafe bags have a proven track record with a wide range of cell lines including CHO, NS0, SF9, E. coli, T cells, and mesenchymal stem cells. Using Flexsafe RM bags in the seed train allows for easy scale-up to the BioStat STR single-use bioreactor that utilizes Flexsafe STR bags. The same polyethylene film material can be used for all cell culture steps. Flexsafe RM bags can be used with rocking bioreactors from multiple manufacturers, providing excellent growth characteristics and robustness, with stable supply.

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Q, DEAE, and CM Ceramic HyperD F ion exchange resins are high-capacity resins designed for the efficient and scalable purification of biomolecules. <Features> ■ High dynamic binding capacity at high flow rates ■ Truly rigid, non-compressible resin ■ Salt-tolerant CM Ceramic HyperD F resin reduces the need for ultrafiltration (UF) and dialysis filtration (DF) Ceramic HyperD F resin is manufactured in facilities compliant with ISO 9001:2008 and ISO 14001:2004.

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**Features** - Single-use TFF specifically designed for 1 to 20L scale, providing cost-effective solutions from process development to pilot. - Ready-to-use and closed system, resulting in low bio-burden risk. **Characteristics in ADC Manufacturing** - Automation of three processes: ADC synthesis, precipitate removal, and TFF within a single system. - Reduction of funding, labor, installation space, and process risks, enabling a seamless transition from process development to small-scale commercial ADC manufacturing. - Flexible process sequence control allows for compatibility with various ADC manufacturing protocols. - Stirring optimized for minimal capacity with temperature control.

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■ Design considering efficiency in the SUTFF application ■ Automation that supports advanced operations ■ User-friendly and quick setup

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Single-use technology brings many benefits to biopharmaceutical manufacturing, enabling simpler operations. Single-use TFF systems simplify the process of ultrafiltration/diafiltration by fully controlling key parameters. ▪ Excellent engineering design that provides reliability, control performance, and ease of use ▪ Fully automated control and monitoring of process parameters ▪ Equipped with calibrated sensors, gamma-sterilized manifolds can be installed quickly and easily

• Filtration Equipment
• Other physicochemical equipment

Sartobind Convec D is a dedicated weakly basic anion exchange chromatography solution designed for the efficient downstream processing of lentiviral vectors. This chromatography membrane, utilizing convective mass transfer and weakly basic anion exchange chemistry, promotes gentle elution of viral particles and ensures recovery while maintaining high infectivity during the purification process.

• Chromatography
• Chromatography Consumables
• Ion Chromatography

The Green Line, a single-use hollow fiber module, offers an optimal solution that saves costs and time, reduces space, and features a design that can be flexibly scaled up. By matching materials, fluid pathway lengths, and performance characteristics, it achieves the expected linear scale-up from lab and pilot scales to manufacturing scale. It is scalable from batch capacities of over 10 mL to 1,500 L, with membrane areas available from 0.0052 m² to 15.42 m². The single-use line module is available with molecular weight cut-offs (MWCO) ranging from 3 kD to 750 kD, pore sizes from 0.1 μm to 0.65 μm, and hollow fiber inner diameters of 0.5 mm, 1.0 mm, and 2.0 mm.

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• Separation device

This filter sets high standards for the requirements needed for single-use applications and meets them. The retention of particles, retention of phages, and of course, the retention of bacteria in air and liquids are specifications that demonstrate the quality of Zaltopore Air. The integrity tests conducted on 100% of the products in the factory guarantee the quality of each filter before use. With excellent and stable flow over long periods, it provides an efficient process.

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The flow assembly for the Green Line single-use hollow fiber module provides a fully integrated single-use cross-flow solution that can be freely designed without the need for assembly, pre-washing, or cleaning. The sizes of the Green Line hollow fiber modules range from the Discover Lab scale module to mass production scale maximizers and Grand XL, capable of processing up to 1,500 liters per module. <The flow assembly for the Green Line includes, in addition to the Green Line hollow fiber module, the following items as standard or bags tailored to customer specifications upon request:> ■ Single-use pump head ■ Tubes for feed liquid, circulation liquid, and permeate liquid ■ Single-use pressure sensor/transducer ■ Single-use integrated flow sensor or reusable clamp-type flow meter/sensor ■ And sterile connectors ■ Easy detachable connectors

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This filter sets high standards for the requirements needed for single-use applications and meets them. The specifications that demonstrate the quality of the Zaltpore Air Midizart include particle retention, phage capture, and of course, the capture of bacteria in both air and liquid (in both directions). The integrity tests conducted on 100% of the products in the factory guarantee the quality of each filter before use. With excellent stable flow over long periods, it provides an efficient process. Since it does not contain fleece, no particles are released. Its lightweight structure prevents twisting of the tubes.

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Product Benefits Virosart Max significantly enhances the robustness and processing capacity of final virus filters by efficiently protecting the virus removal membrane. The most troublesome molecules for the final virus removal membrane are aggregates and small hydrophobic molecules. Virosart Max can bind aggregates extremely efficiently, independent of process conditions such as conductivity, due to hydrophobic interactions. The clean three-layer membrane material exhibits excellent adsorption capacity, making it optimal for this process stage. The T-style design of Virosart Max Maxicaps is ideal for easily installing multiple filters in series or parallel.

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By using Virosart HF, high viral safety is provided for biopharmaceuticals. Virosart HF is based on a uniquely modified PES membrane, which offers extremely excellent processing capacity and very high flow rates. Due to the high packing density of the elements, the hold-up volume and flushing capacity are extremely low, minimizing the installation area. Delivered in a sterile state, it is user-friendly and allows for quick installation of the filter elements. Virosart HF can capture small non-enveloped viruses (such as PPV, MVM) at over 4 log10 and large enveloped viruses (such as MuLV) at over 6 log10. This filter demonstrates high viral retention performance throughout the filtration process, regardless of the operating pressure, without a decrease in filtration flow rate.

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The Zaltclear Depth Filter product family is a cellulose-based filter that contains diatomaceous earth. It is used in the biotechnology and pharmaceutical industries, where high solid removal capabilities are required to meet strict standards. In a dual-layer (DL) format, it can filter cell culture media with a cell density of less than 15×10⁶/mL from the process development stage to the commercial production stage.

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- In the cell centrifugation process, shear forces are kept low, allowing for a seamless transition from process development (0.1 L) to GMP-compliant manufacturing (20 L). - In the closed system cell recovery process, cell processing time is reduced by 50%. - Cell recovery rate improved to over 90%. - Robust results achieved even at a cell density of up to 108 cells/mL. - Improved cell viability due to low shear counterflow separation.

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The kSep system is a fully automated single-use centrifugation system that continuously concentrates, washes, and recovers supernatant or solids (cell particles). It is ideal for cell separation from fed-batch culture, high-density culture, and concentrated culture, maintaining a high cell survival rate with minimized shear stress, addressing the challenges of traditional centrifugation and filtration-based technologies.

• centrifuge

As concerns about viral contamination rise, biopharmaceutical manufacturers are required to verify the effectiveness of their virus clearance processes. Sartorius's Confidence Virus Clearance Service offers consulting from experts in process design and optimization to support purification processes. By using high-purity virus stocks, we guarantee robust and reliable results, achieving a rapid turnaround time of just six weeks. This comprehensive virus clearance solution provides the "confidence" needed for your processes. Features and Benefits: ■ Evaluation of downstream unit operations for virus clearance ■ GLP testing ■ Non-GLP testing ■ High-purity virus stocks that guarantee reliable and trustworthy results ■ Time and cost savings by consolidating virus clearance products and services with a single provider ■ On-site flexibility | No need for sponsor presence

• Other physicochemical equipment
• Contract measurement
• Contract Inspection

▪ Conducting validation tests at a speed of 12 weeks ▪ Unique expertise in E&L ▪ Cost efficiency through a risk-based approach

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The CIM monolith column enables high-purity chromatography purification in 2 or 3 steps for viral vectors and nucleic acids (mRNA, pDNA, oligonucleotides) such as AAV used in cell and gene therapy, vaccine manufacturing, as well as for bio-nanoparticles like exosomes, and for the purification of peptides, proteins, and antibodies. With demonstrated scalability from 1 mL to 8000 mL, we support efforts to enhance productivity and process efficiency in biotechnology through the provision of pre-packed cGMP formats, fast run times, large capacities, and purification packages tailored to specific fields and modalities.

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• Other physicochemical equipment

Mixed-mode resins have the following features: ■ Purification of proteins at low ionic strength by directly capturing hydrophobic sites ■ Separation of complex mixtures due to new ligand selectivity ■ Orthogonal to each step of chromatography, such as ion exchange

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HyperCel STAR AX is a salt-tolerant anion exchange resin designed for bioprocessing. ■ High DBC (dynamic binding capacity) with a short residence time (less than 2 minutes) ■ Direct capture of proteins or removal of impurities from undiluted feedstock at moderate to high conductivity ■ Excellent selectivity across a wide range of conductivity ■ Rapid processing, improved economic efficiency of the process

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Heparin HyperD M resin is a technically advanced, high-speed, large-capacity affinity chromatography resin suitable for the purification of biomolecules that bind to heparin, such as coagulation factors, growth factors, and lipoproteins. The unique composite structure of Heparin HyperD M has been designed to provide excellent dynamic capacity at high linear fluid velocities. HyperD resin consists of porous, rigid mineral beads containing heparin bound to the hydrogel filling pores. Heparin HyperD M has an average particle size of 80 μm and is used in the purification of ATIII at scale. The resin can be packed into columns of various sizes, from milliliters to over 100 liters, and operates at low back pressure and high flow rates.

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【Features】 ▪ High-speed, high-resolution HPLC analysis for pDNA processes ▪ Acceleration of PD and stabilization of manufacturing and quality through at-line monitoring ▪ Ability to obtain a lot of important information in a short time, with low effort and low cost ▪ Unique monolithic column for CIMac pDNA analysis ▪ User guide, dedicated validated methods, SOPs, and standard materials included

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Use of RoboColumn chromatography columns in high-throughput testing of loading conditions for HyperCel STAR AX resin and MEP HyperCel resin for MAb purification using flow-through mode.

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Hydrophobic Charge Induction Chromatography (HCIC) MEP HyperCel can withstand rigorous stationary phase cleaning methods (0.5–1 M NaOH, contact time 30–60 minutes), which ensures a long resin lifespan. All of these factors contribute to reducing purification costs. 【Product Features】 ■ Separation of proteins using a unique separation mechanism and selectivity ■ A salt-free/low-salt solution that replaces Hydrophobic Interaction Chromatography (HIC) ■ Capture and intermediate purification of monoclonal IgG and polyclonal IgG (removal of aggregates, DNA, and HCP) ■ Improvement of process economics

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Hydroxyapatite chromatography is considered to be "pseudo-affinity" chromatography or "mixed-mode" ion exchange. It has been demonstrated to be an effective purification mechanism in various processes, providing biomolecular selectivity that further complements traditional ion exchange or hydrophobic interaction methods. HA Ultrogel is easily scalable and is used in multi-liter column applications, starting from research scale. ■ Effective purification mechanism in various processes ■ High porosity ■ Easy cleaning ■ Usable in large-scale bioprocesses

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■ Immediately usable consumables, quick and easy setup ■ Scalable and cost-effective portfolio ■ Process enhancement and timeline reduction possible ■ Membrane design with short residence time, compatible with a variety of mAb sizes ■ Design that maximizes membrane lifespan ■ Consulting services by experts

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Sartobind Convec SC is a pseudo-affinity chromatography solution specialized for the downstream processing of viruses and viral particles such as influenza, rabies, and human herpes simplex virus. This system promotes the efficient recovery of purified viral particles by integrating convective mass transfer, pseudo-affinity chemistry, and optimized elution conditions.

• Chromatography Consumables
• Chromatography
• Other Chromatograph

Zaltobind is a membrane absorber that enables efficient and ultra-fast purification through its macroporous structure and optimized design. It is an economical solution to the challenges of bioprocessing and demonstrates excellent performance in purification platforms.

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**Features** - The efficiency of the unit operations inherent in the BioSMB PD system allows for a reduction of up to 80% in the cost of media in chromatography without changing the resins or buffers used in the chromatography process. - All chromatography processes can be conducted with only a fraction of the media and buffers required to obtain the same amount of substance in a conventional batch process. - The ability to use up to 16 columns enhances productivity and application flexibility. - By installing a buffer selection valve, composition gradients and cleaning steps are unnecessary. *You can watch the webinar at the following URL:* https://bit.ly/3yaB65S *title: 'Virtual Demonstration and Conceptual Overview of the BioSMB Multi-Column Chromatography Platform'*

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**Features** - Utilization of high-efficiency resin - High productivity - Overwhelming flexibility, capable of manifold installation within 30 minutes The BioSMB platform offers a highly flexible multi-column chromatography system. It achieves high throughput and efficient resin utilization compared to traditional batch and other continuous production chromatography. Flexible flow configurations are possible through a valve cassette composed of eight special single-use columns. *You can watch the webinar from the following URL:* https://bit.ly/3yaB65S *Title: 'Virtual Demonstration and Conceptual Overview of the BioSMB Multi-Column Chromatography Platform'*

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▪ Space-saving (700 × 1,000 × 1,830 mm) ▪ Two modes: combination-elution and flow-through ▪ Rotary HMI, keyboard and touchscreen ▪ Low-pulsation volumetric pump - small dead volume (entire system: 190 mL) ▪ Clear inlet: mixing point of feed line and buffer line close to the membrane absorber ▪ Significantly reduced switching time with optimal valve: 0.5 seconds ▪ Full-spectrum UV sensor ▪ Real-time monitoring and prediction by Umetrics

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