レプリジェンジャパン List of Products and Services

This document is the Japanese version of the user guide for "AVIPure AAV Affinity Resins." "AVIPure" is an affinity resin that is alkali-resistant and allows for the easy one-step purification of serum-type specific adeno-associated virus (AAV) vectors from clarified cell culture fluid (CCCF). It also includes tables on "Performance Characteristics of AAV Affinity Resins" and "Recommended Purification Workflow for Viral Vectors from Concentrated CCCF." We encourage you to read it. [Contents (partial)] ■ AVIPure–AAV Affinity Resins: AAV2, AAV8, and AAV9 ■ Recommendations for Process Development - Equilibration and Binding Conditions - Washing Conditions - Elution Conditions - CIP Conditions *For more details, please download the PDF or feel free to contact us.

• Column Chromatography

We would like to introduce the "KrosFlo KR2i RPM System" tangential flow filtration system and inline protein concentration management. The "Tangential Flow Filtration (TFF) System" measures concentration during UF/DF operations. There is no longer a need to rely on offline fixed-length UV-Vis spectrophotometers. This system can measure protein concentration in real-time. 【Features】 ■ Simplified automated operation ■ Robust processing capability ■ Minimization of risk ■ Flexible configuration *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

The "XCell ATF Lab Devices" can scale up linearly from PD to manufacturing. The "XCell ATF 1 device" features a minimal capacity and includes accessories such as AseptiQuik connectors and permeable liquid pressure sensors. The "0.5-2L XCell ATF 1" reduces media costs and supports scale-up to 5000L. 【Features of XCell ATF Technology】 ■ Delivering faster and more - Improved throughput - Increased productivity - Enhanced cell capacity *For more details, please download the PDF or feel free to contact us.

• Culture medium

The "XCell Lab System" enables simple, rapid, and cost-effective upstream process development. With process data and a new scale-down device model, it is possible to provide complete characterization data. Additionally, each component has been rigorously tested to function as a complete solution. 【Features】 ■ Precision engineering and simple design ■ Up to two XCell ATF devices can be connected to one controller ■ Real-time monitoring of filter status by measuring the transmembrane pressure *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

"TFDF (Tangential Flow Depth Filtration)" is a solution that integrates the advantages of Tangential Flow (TF) and Depth Filtration (DF). The tubular depth filter captures cells and debris, causing almost no retention of the process liquid. Additionally, there is a dry type that does not contain sodium hydroxide, glycerin, preservatives, or ethanol, allowing for a zero-flush start with "TFDF Flow Paths." 【Synergistic benefits】 ■ Depth filter: High capacity with minimal retention of sample liquid ■ Tangential flow filter: Reduces reverse osmosis of the membrane due to concentration differences in the process liquid ■ Integrated system: Typically operates for 3 to 6 hours at over 1000 LMH *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

This document introduces "Enabling Next Generation Holderless Flat Sheet TFF." The tangential flow filtration (TFF) flat sheet cassettes include reusable products (PRO) and single-use products (SIUS). The SIUS TFF cassette is for single use, but requires a filter plate insert (FPI) and a clamp or stainless steel holder. 【Contents】 ■Summary ■Table 1. TangenX Devices ■Table 2. TangenX SC Product Portfolio ■Table 3. Technical Specifications ■Conclusion *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

The "Repligen ProConnex Valve" enhances the usability and efficiency of OPUS pre-packed columns through innovative Artesyn technology. Its lightweight polymer structure allows for direct attachment to both the inlet and outlet ports. This reduces the risk of column damage and simplifies tube attachment, streamlining setup in manufacturing environments. 【Features】 ■ Lightweight polymer valve can be directly connected to OPUS columns ■ Easy to use with clear open/close indicators ■ Three ports: inlet, outlet, and bypass ■ Smooth and sealed flow control with no dead legs ■ Simple usability that does not require additional gaskets *For more details, please download the PDF or feel free to contact us.

• Valves and fittings

"LONG R3 IGF-I" has 200 times the potency of insulin and enables stable cell culture. This product is a proliferation-promoting growth factor designed to significantly increase the yield in mammalian cell culture. It is an analog formulation of human IGF-I, specially designed and manufactured for mammalian cell culture to support large-scale production of biopharmaceuticals. Additionally, we offer the "LONG R3 IGF-I ELISA Kit," which allows for the quantification of this product in both cell culture media and raw material samples. [Features] ■ Efficiency ■ Simplicity ■ Cost-effective ■ ISO 9001 ■ Stable supply *For more details, please download the PDF or feel free to contact us.

• Other Culture

We handle the "KrosFlo FS-15 and FS-500 TFF systems." The "KrosFlo FS TFF system" is a flat sheet type TFF system that accommodates capacities from 140 mL to 500 L. The Quattroflow 150 SU pump of the "KrosFlo FS-15 TFF system" supports flat sheet cassettes up to 0.3 m with a maximum flow rate of 3 LPM and a maximum pressure of 4 bar. 【Components of the Flat Sheet TFF System】 ■ KF Comm 2 Software ■ Quattroflow Diaphragm Pump ■ Peristaltic Assist Pump ■ Automatic Pressure Control Valve (ABV) ■ Scale (Weighing Device) ■ TangenX Flat Sheet Cassette Assembly ■ Permeate Flow Rate Sensor *For more details, please download the PDF or feel free to contact us.

• Other storage and equipment

We handle the "KrosFlo RS 10 TFF Systems." The "1/8 inch KrosFlo single-use tangential flow filtration (TFF) system" significantly improves product yield and operational efficiency through end-to-end (E2E) automation for bench-scale manufacturing. Additionally, the "ProConnex FlowPath" integrates advanced fluid management technologies such as injection molded tubing, pump heads, filters, and sensors into a single-use device. 【Filtration (TFF) System Components (partial)】 ■ Scale ■ Feed pump (maglev, diaphragm, or peristaltic pump) ■ Permeate side scale ■ Touch screen (21 inches) ■ Peristaltic pump (permeate control) *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

The "KrosFlo KR2i TFF System" is an automatic TFF system suitable for processes up to 15L with a minimum circulation volume of 2mL. Repligen's single-use TFF systems provide high-quality and reproducible results. Additionally, we offer the automatic TFF pump system "KrosFlo KMPi TFF System," which accommodates processing volumes from 0.1L to 500L, with a minimum circulation volume of approximately 100mL, making it suitable for pilot scale. 【Components (partial)】 ■ KF Comm 2 software ■ Digital control peristaltic pump ■ Pump head ■ Automatic pressure regulating valve (ABV) ■ Pressure sensor *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

The "Spectrum Hollow Fiber Filter" functions as a filtration membrane for the ultrafiltration of biological products, dialysis filtration, and precision filtration processes. The hollow fibers are fixed in a housing, designed for high-pressure applications, and manufactured in accordance with ISO guidelines. With a wide range of combinations in module size, surface area, and chemical properties of the membrane, we offer over 1,400 different product lines to meet process needs. 【Features】 ■ Over 1,400 product lines ■ Operating pressure tolerance of 30 psi ■ Simple design, Ready-To-Use ■ No external clamps or torque processes required *For more details, please download the PDF or feel free to contact us.

• Filters

Ceramic Hydroxyapatite (CHT) resin exhibits unique selectivity in the purification of mAbs and recombinant proteins. Additionally, the 'OPUS column' has been pre-packed with CHT resin, allowing for excellent performance and worldwide shipping. Please feel free to contact us when you need assistance. 【Specifications】 ■ Column inner diameter: 5-45 cm ■ Bed height: 5-30 cm *For more details, please download the PDF or feel free to contact us.

• Chromatography

"CaptivA Protein A Affinity Resin" is currently the highest class of cost-effective chromatography resin available. It offers excellent binding capacity, alkaline stability, and high elution at a fraction of the cost of conventional resins. This product combines industry-standard cross-linked agarose beads with recombinant Staphylococcal Protein A (rSPA) from Repligen, a global manufacturer of recombinant Protein A. 【Features】 ■ Expanding three commercial processes and Ph.1-3 pipelines ■ High dynamic binding capacity of 30-40 mg/mL ■ Class-leading elution amount of IgG below 10 ng/mg ■ Stable global supply *For more details, please download the PDF or feel free to contact us.

• Other Chromatograph

"AVIPure AAV Affinity Resin" can be used in the initial purification steps for adeno-associated virus (AAV) serotypes 2, 8, and 9. To improve the economic efficiency of the process, cleaning with alkaline solutions (CIP) is possible, making it a new resin for AAV purification. Agarose beads with a particle size of 50μm can be packed into standard bioprocess columns. 【Features】 ■ Enhanced performance of AVIPure and resin regeneration ■ Capture process with a 2-minute residence time ■ Reduction of HCP and residual DNA ■ Maintenance of resin performance through NaOH CIP regeneration *For more details, please download the PDF or feel free to contact us.

• Other storage and equipment

The "KrosFlo KR2i RPM System" is a system that integrates real-time process management with lab-scale tangential flow filtration (TFF). This system combines the KrosFlo KR2i system with the CTech FlowVPX variable path length UV-Vis spectrophotometer, providing automated TFF with inline concentration monitoring and endpoint control. By combining the functionalities of KR2i and FlowVPX, it achieves improved process control and efficiency, as well as reduced process risks. 【Features】 ■ Enhances process control with high accuracy and reproducibility of results ■ Increases process efficiency by shortening cycle times and improving yields ■ Reduces process risks by ensuring accurate concentration in TFF processes *For more details, please download the PDF or feel free to contact us.

• Filtration Equipment

The "Repligen ProConnex TPE Tube" is a new extruded product that is translucent, can be welded, and is heat sealable. It is compatible with commercially available sealers and other companies' TPE tubes. It has been tested for extractables according to BPOG 2020 standards (after gamma irradiation > 45kGy). Please feel free to contact us when you need assistance. 【Features】 ■ Sterile welding and heat sealing possible ■ Contains no animal-derived components ■ Translucent with minimal color change after irradiation ■ Operating pressure equal to or greater than commonly available weldable TPE tubes in the industry ■ Improved peristaltic pump performance compared to standard weldable TPE *For more details, please download the PDF or feel free to contact us.

• Tubes and hoses

The "OPUS 45R, 60R, 80R columns" purify feed streams from bioreactors of various manufacturing scales. In response to the need for scaling up chromatography processes, we offer pre-packed columns for the bioprocess industry. These products are designed to meet the requirements of large single-use bioreactors of 1000L and 2000L. 【Features】 ■ Cost and labor savings: Achieved over 65% cost reduction and up to 80% labor cost reduction compared to hand-packed columns. *For more details, please download the PDF or feel free to contact us.

• Column Chromatography

"ProConnex" is a rigid container specially designed for bioprocesses. Made of high-purity PP, it features a design with no internal gaps, supported by integrity testing and data packages. Since design modifications such as ports and handles are possible, it can optimize your processes. 【Features】 ■ Sizes range from 1L to 50L ■ No animal-derived components ■ Sterilization methods ・ Gamma irradiation up to 45kGy ・ Autoclave sterilization at 121°C for 60 minutes *For more details, please download the PDF or feel free to contact us.

• Bottles and containers

This document is an application note for "Solo VPE." The measurement of DNA purity in gene therapy plasmids in the presence of proteins can be assessed using the UV absorbance ratio of 260/280. However, this method has challenges when accurate quantification of DNA purity is required. Our product and its slope spectrophotometry offer a new method to accurately measure DNA purity ratios and overcome these challenges. [Contents] ■Summary ■Apparatus/Equipment ■Method & Results ■Analysis ■Conclusion ■References *For more details, please download the PDF or feel free to contact us.

• Gene expression analysis contract

We offer the "KrosFlo KR2i RPM System," which integrates real-time process management with lab-scale tangential flow filtration (TFF). This system combines the KrosFlo KR2i system with the CTech FlowVPX variable path length UV-Vis spectrophotometer, providing automated TFF with inline concentration monitoring and endpoint control. By combining the functionalities of KR2i and FlowVPX, we achieve improved process control and efficiency, as well as reduced process risks. 【Features】 ■ Enhances process control with high precision and reproducibility of results ■ Increases process efficiency by shortening cycle times and improving yield ■ Reduces process risks by ensuring accurate concentration in TFF processes *For more details, please download the PDF or feel free to contact us.

• Other filtration and separation equipment