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

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.

**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'*

**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'*

▪ 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

【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

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.

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

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

■ 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

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.

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.

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.

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.

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

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.

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

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

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

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.

【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

**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.