Cytiva List of Products and Services

The Image Integrity Checker is a free software for authenticating raw data such as electrophoresis and Western blotting images. It counters the threats of the AI image generation era through raw data authentication using digital fingerprints and issuing certificates for paper submissions. ● Usable with data obtained from Cytiva's Amersham ImageQuant(TM) 800 and Typhoon(TM) series ● Available for free download from the Cytiva website 【Authentication Procedure to Deny Raw Data Tampering】 Step 1: Raw image data with digital fingerprint authentication from ImageQuant 800 / Typhoon Step 2: Authenticate raw data with Image Integrity Checker Step 3: Attach the raw data authentication report when submitting the paper \Currently holding a Western Blotting Image Quiz Campaign!!/ The first 200 applicants will receive a cutlery set! ▼ Apply here https://cytiva.link/iin3h

• Electrophoresis

This course is divided into upstream, scale-up, and downstream applications, providing a series of technical knowledge. You will learn the steps of a typical workflow in cell therapy manufacturing, covering topics such as cell separation, expansion, harvest, and cryopreservation. Through this course, you will learn how automation and closed-system processes can contribute to the manufacturing of reproducible therapies. Guidance on creating, documenting, automating, and digitizing standard operating procedures (SOPs) will also be provided.

• Other medical supplies and cosmetics manufacturing machines

Cytiva Protein Select resin allows for the spontaneous cleavage between the tag and the target protein during the affinity step, resulting in the elution of high-purity target protein without any residual amino acids from the tag. 【Self-Cleavage of the Tag】 The Cytiva Protein Select tag binds to the ligand on the resin, and after a certain period, the tag is cleaved from the target protein. This means that no enzymatic digestion is required! 【No Residual Amino Acids from the Tag】 Since the cleavage occurs between the tag and the target, no amino acids from the tag remain in the target protein. 【High Purity in One Step】 The cleaved target can be eluted from the column simply by flowing the starting buffer. There is no need for pH changes or the addition of reagents for elution.

• Chromatography

MabSelect VH3 affinity resin uses a protein A ligand designed to interact exclusively with the variable heavy chain of the human antibody VH3 sequence family. This allows for the efficient separation of fragments such as bispecific antibodies (bsAb), fragment antigen-binding regions (Fab), single-chain variable fragments (scFv), and variable heavy chain domains (VHH). • Interacts only with the variable heavy chain of VH3, not with the Fc region • High binding capacity for antibody fragments with VH3 • Removal of antibody-derived impurities from asymmetric bsAb with VH3 • Stable even after washing with 0.5 M NaOH

• Research Antibodies

Capto Q increases particle rigidity while maintaining pore size, which is essential for binding capacity at process scale. By coating agarose resin with dextran surface extender, it achieves a high dynamic binding capacity. ● Reduces process time with high binding capacity, high flow rate, and low delivery pressure ● Enables purification at high bed heights with rigid agarose resin ● Allows purification of viscous samples under high flow rate conditions Additionally, separation of AAV full/empty can be achieved through ion exchange chromatography. ● Purification of Full Capsids with a purity of 95-100% ● Improved selectivity with Capto Q's Dextran Extender ● Reduced selectivity with resin lacking Dextran Extender ● Improved selectivity for Full/Empty due to optimized buffer

• Chromatography

Adeno-associated virus (AAV) is widely used as a vector for gene therapy. While it is often purified using ultracentrifugation at the lab scale, this method becomes difficult to scale up. A scalable method for purification is chromatography; however, separating full capsids (hereafter referred to as "full") that contain the genome from empty capsids (hereafter referred to as "empty") that do not contain the genome and do not contribute to titer has been challenging. When using AAV as a vector for gene therapy, it is desirable to remove empty capsids as much as possible due to their impact on titer and issues related to immunogenicity. This application note introduces a scalable AAV purification process and presents a method for separating empty and full capsids using anion exchange chromatography across multiple serotypes.

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ÄKTA oligosynt is a fully automated system for synthesizing oligonucleotides such as DNA and RNA. It builds a robust and scalable oligonucleotide synthesis process, supporting the transition to manufacturing with high synthesis efficiency and quality. ● Supports synthesis scales required for research and process development (up to 12 mmol) ● Equipped with up to 16 inlets for amidites ● Flow paths optimized to minimize hold-up volume ● Inert gas system eliminates the risk of moisture contamination in reagents and amidites ● All modules are accessible from the front, making purging and reactor installation operations simpler ● Equipped with the latest version of UNICORN software

• DNA Synthesizer

● Simulation of chromatograms in the purification process using a computer ● Saving time and costs by reducing the number of experiments ● Enabling smarter and faster process development ● Applicable to a wide range of applications, including the entire process development and scale-up considerations

• Other bio-related products and services

MabSelect PrismA is a chromatography resin for the manufacture of monoclonal antibody pharmaceuticals. The ligand is a recombinant Protein A that has been genetically engineered to maintain alkaline resistance. Due to its high pH stability, it allows for low-cost and efficient cleaning with NaOH. ● Achieves a dynamic binding capacity (DBC) of 80 mg/L with a contact time of 6 minutes ● High alkaline resistance enables efficient cleaning and sanitization ● The rigid base matrix allows for high-throughput purification

• Chromatography

MabSelect VL uses a Protein L ligand that has a strong affinity for the variable regions of human antibodies and κ light chains. This resin provides high productivity and a robust process for the affinity capture of bispecific antibodies and antibody fragments that include κ light chains. It also has the potential as an alternative to complement antibody variants that do not bind to Protein A. Compared to conventional products, it significantly improves dynamic binding capacity (DBC) and alkaline stability, allowing for efficient capture of antibody variants. ● High binding capacity for bispecific antibodies and fragment antibodies containing κ light chains ● Stable even when washed with 0.1M NaOH, reducing the risk of bio-burden incidents ● Effectively separates different combinations of antibodies and impurities generated during the manufacturing process in the purification of bispecific antibodies

• Chromatography

To efficiently purify proteins, it is important to consider carriers and purification schemes tailored to the specific purpose. ÄKTA avant is a chromatography system that can efficiently and automatically evaluate various conditions of purification schemes. ●SPEED: The scouting function and DoE (Design of Experiments) capability allow for efficient selection of carriers and optimization of parameters. ●SCALABILITY: Compatible with a wide range from HiScreen columns to AxiChrom columns, suitable for screening, method optimization, and robustness testing. ●SECURITY: Automatic column recognition and usage history managed in a database. ●SECURITY: Built-in fraction collector protects samples from dust and includes cooling functionality. ●Automatic buffer preparation online with BufferPro reduces purification time with high-flow carriers.

• Column Chromatography

ÄKTA pure is a chromatography system that allows you to choose specifications according to your budget and research content, and freely combine functions. After purchasing the system, you can easily add or change functions. Additionally, the operation section is centralized at the front of the device, making it easy to work within the chamber, and the design is user-friendly. The control software UNICORN allows for easy and flexible programming and editing of purification processes using a drag-and-drop method for phases, so no special programming skills are required. ● Functions can be freely added or changed according to the research progress, from beginners to expert researchers. ● The operation section is centralized at the front of the device, allowing for stress-free work.

• Column Chromatography

The Amersham™ ImageQuant™ 800 series is the latest model of CCD imager that combines the technologies of Fujifilm and Cytiva. With the newly added SNOW mode, it is now easier than ever to capture clearer images. The ImageQuant™ 800 equipped with GxP is designed to meet GxP regulatory requirements such as FDA 21CFR Part 11 and EUGMP Annex 11, where data traceability, accountability, and integrity are crucial. ● Logon and access using Windows™ authentication features ● User group assignment and access rights management ● Electronic records and event logs, including related captured images ● Achieving data integrity in image analysis using IQTL GxP analysis software ● Ensuring traceability of electronic data ● Providing development documents, Change Control Notifications (CCN), and external evaluation reports

• Other protein analysis

●General-purpose (generic) ELISA kit for CHO cells ●Evaluation of coverage for low molecular weight HCPs that are difficult to detect ●High sensitivity, wide dynamic range, high dilution linearity ●Cytiva's expertise supporting biopharmaceutical research and manufacturing for over 50 years ●Sales planned for a 2D-WB coverage measurement kit using the same antibody ●Custom anti-HCP antibody manufacturing services available

• Other research reagents

●Improvement of reproducibility in signal intensity/capillary flow time 　　- Suppression of inter-lot variation 　　　　　　Signal intensity: Below 10% CV 　　　　　　Capillary flow time: Below 10% CV 　　- Suppression of intra-lot variation 　　　　　　Signal intensity: Below 10% CV 　　　　　　Capillary flow time: Below 10% CV ●Cost reduction in assay optimization through improved reproducibility In in vitro diagnostics, there is a demand for the development of test kits that can reliably and quickly detect target molecules contained in liquids such as water, urine, blood, and saliva, and provide results. FF HP is a nitrocellulose membrane optimized for lateral flow assays. By reviewing the manufacturing process and making improvements such as a powder-free surface that is crucial for sharp judgment lines, high reproducibility in immunoassay tests has been achieved. FFHP and FFHP Plus use different surfactants. FFHP Plus Thick is a new series with a thicker membrane that uses the same surfactant as FFHP Plus (approximately 235 µm thick including backing).

• Other medical supplies and cosmetic manufacturing materials

■Designed for small-scale manufacturing With low hold-up volume and versatility, it is possible to efficiently purify small amounts of reagents. ■Flexibility The easily attachable flow kit allows for quick replacement. Additionally, it reduces the time associated with cleaning validation. ■Reduced contamination risk The single-use flow path, which allows for sealed processing, reduces the risk of contamination. ■Compact design Being a benchtop model, it has a small footprint, effectively utilizing space.

• Column Chromatography

Smart process development uses tools and methodologies to improve process outcomes and shorten time to market. When new modalities are adopted into the pipeline, there is often a lack of platform process solutions, making the pursuit of smart process development a potentially important differentiating factor. For example, the evolution of process development methods is shifting developers from examining one factor at a time to multivariate data analysis. This analysis employs statistical models such as Design of Experiments (DoE) and, more recently, equation-based mechanistic models. Additionally, the parallelization and automation of experimental setups known as high-throughput process development (HTPD) have made more information available with fewer samples. All of these tools and methodologies enable the acceleration of process development and enhance the understanding, robustness, and performance of processes overall. This eBook presents insights into the factors for conducting process development more smartly and quickly, as well as methods for streamlining workflows in upstream and downstream process development.

• Process Development

The iCELLis® single-use bioreactor is an integrated high-density cell culture bioreactor that combines the advantages of single-use technology and fixed-bed bioreactors to simplify processes. Designed with a focus on rapid setup and ease of use, this compact system allows for a cell adhesion area of 4 square meters in a benchtop system, and commercial production systems can achieve a maximum culture area of 500 square meters with just 3.2 square meters of footprint! It enables cell seeding at lower densities (1000 cells/cm² for Vero cells), significantly reducing manual labor and associated costs by simplifying the process. **Features** - Simplification of the process from pre-culture to product - Integrated single-use bioreactor - Rapid process development due to simple structure - Linear scalability from research and development to actual production - High cell density achieves reduced volume and increased productivity compared to traditional tank stirred bioreactors *For more details, please refer to the PDF document or feel free to contact us.*

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The "Pegasus(TM) Prime Virus Filter" reliably removes viruses, protecting critical biopharmaceutical manufacturing processes from viral contamination and ensuring the quality of pharmaceuticals and safety for health. Delivered gamma-irradiated from small scale to process scale, it features high flow rates and stable filtration performance, enabling process simplification, reduction, and continuous cost savings across a wide range of scales. [Features] - Stable high virus removal performance regardless of process fluids or parameters - Stable filtration performance with high flow rates - Gamma sterilized - Scalable - Constant filtration area ratio of pre-filters to virus filters across all scales For more details, please refer to the catalog or feel free to contact us.

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The iCELLis® single-use bioreactor is an integrated high-density cell culture bioreactor that combines the advantages of single-use technology and fixed-bed bioreactors to simplify processes. Designed with a focus on rapid setup and ease of use, this compact system allows for a cell adhesion area of 4 square meters in a benchtop system, and commercial production systems can achieve a maximum culture area of 500 square meters with just 3.2 square meters of footprint! It enables cell seeding at lower densities (1000 cells/cm² for Vero cells), significantly reducing manual labor and associated costs by simplifying the process. 【Features】 ■ Simplifies the process from pre-culture to product ■ Integrated single-use bioreactor ■ Rapid process development due to simple structure ■ Linear scalability from research and development to actual production ■ High cell density achieves volume reduction and productivity improvement compared to traditional tank stirred bioreactors *For more details, please refer to the PDF document or feel free to contact us.

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The Allegro(TM) STR single-use bioreactor achieves high mixing capabilities and a low overall height of less than 3 meters, even with a capacity of 2,000 L, thanks to its rectangular culture vessel, which surpasses the performance of traditional cylindrical culture vessels. ■ High Mixing Capability The effective baffle effect of the rectangular culture vessel and the elephant ear-shaped mixing blades allow for the desired oxygen transfer rate to be achieved at lower stirring speeds than before. This results in high kLa and P/V values, reducing shear stress on cells during cultivation at lower stirring speeds. ■ Geometric Similarity Across All Scales, Including Mixing Blades Maintains a similar shape across all scales of 50, 200 L, 500 L, 1,000 L, and 2,000 L. ■ Scalable with Constant P/V Due to geometric similarity and the ability to achieve high P/V values, scaling up with constant P/V is possible. ■ Overall Height Below 3 M Even at 2,000 L Significantly reduces the need for high-altitude work, ensuring the safety of operators. ■ Easy Installation of Dedicated Culture Bags After transporting the single-use culture bag into the culture vessel, it can be set up within 30 minutes with minimal operator intervention.

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The Stax(TM) mAx clarification platform is a robust, safe, and economical clarification solution that minimizes the use of centrifuges and additives. It consists of a four-layer filter system that combines a coarse clarification grade two-layer depth filter with a precise clarification grade two-layer depth filter. This optimized combination provides stable and high processing capacity that is less affected by cell density and viable cell rates. For culture media with a cell density of 35x10^6 cells/mL and turbidity of approximately 3,000 NTU, the required filtration area is reduced by 25-50% compared to conventional products. It achieves a scalable and simple clarification process that contributes to cost reduction and reduced installation area. ■ Do not want to use a centrifuge ■ Do not want to use additives ■ Want stable processing capacity despite variations in cell density and viable cell rates ■ Struggling with the high usage of depth filters This is ideal for those who have these needs. We are accepting trials using your cell culture media at any time. Please contact us for more details.

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Of the biopharmaceutical active ingredients, 59.4% are transported in a frozen state. Therefore, the development of controllable and efficient freezing and thawing technologies is increasingly in demand. For example, in the development of COVID-19 vaccines, there has been a growing emphasis on storage and transportation methods, highlighting the necessity for these solutions. Recently, the combination of Allegro BioContainers and RoSS Technology has resulted in the development of an excellent active ingredient management solution through synergistic effects. It allows for the control of frozen active ingredients between the purification process and the formulation and filling processes, enabling stable and safe storage and transportation. Additionally, it prevents losses of active ingredients due to the breakage of frozen single-use packs, bringing the risk of loss close to 0%.

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Enfron® PFR is a hydrophobic filter with sterilizing grade (0.2μm) that achieves high flow characteristics and long filtration life. It demonstrates excellent durability for the filtration and sterilization of pressurized air, various vent applications, and repeated steam sterilization. 【Main Features】 ■ Validated as a sterilizing grade filter through a bacterial challenge test using B. diminuta (ATCC19146) at a concentration of 1x10^7 cfu/square centimeter or more. ■ Also validated through challenge tests using aerosolized B. diminuta and PP7 bacteriophage (25 nm). ■ Improved reverse pressure strength of the filter cartridge during in-line steam sterilization (SIP) to 0.05 MPa (125°C). ■ Integrity tests that correlate with sterilization performance are possible (forward flow test, pressure hold test, water intrusion test).

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Are you worried that introducing single-use technology will increase manual operations and lead to more human errors? Even with single-use equipment, full automation can be achieved just like with traditional stainless steel lines, and it's easy to do. In traditional automation systems for stainless steel piping and tanks, SIP and CIP were necessary, resulting in a vast number of valves and pipes, making it impossible to realize an automated process without constructing complex sequences. However, with automation systems for single-use processes, SIP and CIP are eliminated, allowing for automation through simple automatic sequences. With the Allegro MVP single-use automation system, sequences can be developed simply by inputting the parameters of unit processes and stacking them up. This enables customers to easily develop sequences on their own. Multiple sequences can be set up. Operators can select the sequence according to the process they are performing, and by simply pressing the Start button, the automated process begins. This eliminates human errors such as mistakenly opening clamps. *For more details, please download the PDF or feel free to contact us.

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Allegro(TM) single-use filling needles feature hydrophobic properties due to their unique reinforced polyether ether ketone (PEEK) material and offer a wide range of inner diameters. They can provide accurate and reliable filling for various types of drugs and volumes, either as part of an autoclave-sterilized assembly or incorporated into gamma-irradiated single-use systems. This leads to a reduction in product loss and process downtime.

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The "Mustang(R) Q Chromatography Capsule" was developed for the recovery and adsorption removal of biomolecules with a negative charge through anion exchange in bioprocess purification processes. It is suitable for the recovery of biomolecules in the early stages of the purification process, as well as for the removal of negatively charged impurities in subsequent purification steps. With a wide range of sizes available, it can accommodate various processing volumes required in the production of biopharmaceuticals. 【Features】 - Biomolecules with a negative charge easily bind in a single pass. - High flow rates allow for large-scale processing within a single workday. - Ready to use and can be sterilized in an autoclave. - Available in capsule or cartridge format. - Compared to traditional columns that require packing and cleaning validation, it reduces operational costs and capital investment. *For more details, please refer to the PDF document or feel free to contact us.

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The "Mustang(R) E Chromatography Capsule" is a high-throughput disposable capsule designed to remove endotoxins from buffers, water, saline, and purification processes. It was developed to adsorb and remove endotoxins in water or more complex solutions through charge and hydrophobic interactions. Being a disposable capsule system, it can accommodate various scales required in the manufacturing process of biopharmaceuticals. 【Features】 ■ Endotoxins are easily bound in a single pass ■ High flow rates allow for large-scale processing within a day's work ■ Ready to use and can also be sterilized by autoclaving ■ Capsule format ■ Adsorbs over 4×10^6 EU of endotoxins per 1 mL of membrane *For more details, please refer to the PDF document or feel free to contact us.

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The "Mustang(R) Q XT Chromatography Capsule" is available in capacities of 5 mL, 50 mL, 140 mL, 450 mL, and 5 L, featuring a 16-layer pleated structure using a Mustang membrane at the tip, providing stable performance and scalability. It captures charged biomolecules in a single pass, demonstrating high binding capacity and flow rate with low pressure loss. The wide range of capsule sizes makes it suitable for various scales and binding capacities required in bioprocesses, from the development stage to full-scale production. 【Features】 - High binding capacity and flow rate with low pressure loss - High flow rate allows for large-scale processing within a day's working hours - Manufactured using a management system based on Six Sigma statistics - No need for cleaning or validation, eliminating the risk of cross-contamination *For more details, please refer to the PDF document or feel free to contact us.

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The "Palltronic AquaWIT IV" is a system developed to perform extremely important integrity tests accurately, reproducibly, and reliably. It involves filling the housing of a hydrophobic filter with water, conducting a water intrusion test, and draining the housing. It features a sanitary design with a removable internal water tank. 【Features】 ■ Fully automated pre-test operations and integrity test cycles for hydrophobic filters ■ Fully automated wetting and testing sequences for hydrophilic filters ■ Automatic control of critical parameters that affect the results of the water intrusion test ■ Designed for use in a GMP environment compliant with electronic record and electronic signature regulations (21 CFR Part 11) *For more details, please refer to the PDF document or feel free to contact us.

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The "CleanPack® Sterile Connector" is a product that allows for easy sterile connections in a dry state. It consists of a male connector and a female connector, each covered with a strip featuring a venting function. This strip uses a pharmaceutical filtration sterilization filter with membranes from Paul, a company with a long-standing track record. This protects the connection surfaces and maintains the sterility of the flow path. 【Features】 ■ No special capital investment required ■ Can be connected in just a few seconds ■ Autoclave sterilization or gamma radiation sterilization is possible ■ Easy to connect even in narrow environments ■ The connection surfaces are covered with a strip, maintaining sterility until use *For more details, please refer to the PDF materials or feel free to contact us.

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The "Omega(TM) Membrane T-Series TFF Cassette" is a product that further evolves the Centramate and Centraset product lines, which have received high praise from customers. It offers a scalable membrane format with effective filtration areas (EFA) ranging from a minimum of 200 cm² to 0.5 m². This format can be applied to process development and small-scale production ranging from 0.1 L to approximately 125 L. 【Features】 - The screen materials on the supply and permeate sides use polypropylene, which has high resistance to sodium hydroxide. - Enlarged flow path ports on the supply and permeate sides achieve low pressure loss. - Designed to maximize mass transfer through the membrane. - Compared to conventional cassette shapes, it reduces processing time and membrane area. *For more details, please refer to the PDF document or feel free to contact us.*

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The "Delta Membrane T-Series TFF Cassette" employs a low protein adsorption Delta membrane, optimizing the manufacturing process. The cassette is designed to enable large volume liquid transfer to improve the customer's manufacturing process, including cost-effectiveness. The new material composition offers excellent durability and stability, with very low leachables, and the membrane can withstand back pressure up to 0.4 MPa. 【Features】 ■ Improves process performance ■ Easy scale-up for robust purification processes ■ Enhanced safety, reliability, and reproducibility ■ High permeability and selectivity, along with low protein adsorption performance *For more details, please refer to the PDF document or feel free to contact us.

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The "CleanPack® Sterile Disconnector" is an easy-to-use product that allows for reliable sterile cutting of flexible tubes even outside of controlled cleaning areas. It maintains the sterility of the flow path not only before cutting but also after cutting. It can be used in all stages of the process, making it particularly suitable for culture processes, liquid preparation processes, and filling processes where ease of use and sterility are essential. 【Features】 ■ Allows tube cutting without compromising the sterility of the flow path even outside of controlled cleaning areas ■ No special environmental maintenance equipment required ■ Can be cut in a short time ■ Easy to cut in tight spaces ■ Sterilization and microbial control via autoclaving or gamma irradiation are possible *For more details, please refer to the PDF document or feel free to contact us.

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"CleanPack(TM) Nova" is a disposable filter for pilot-scale and process-scale production of biopharmaceuticals, biological pharmaceuticals, diagnostic drugs, culture media, and eye drops. It incorporates standard cartridge filters of 10 to 30 inches, which were traditionally mounted in stainless steel housings, into capsule-type plastic housings. We offer a wide range of cartridges for various media, including sterilization filters and virus removal filters. 【Features】 ■ Selection from a rich variety of media and grades ■ Significant cost reduction by minimizing cleaning and validation ■ Easy transition from stainless steel products ■ Improved operational safety ■ Sterilized products are also available *For more details, please refer to the PDF document or feel free to contact us.

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Do you have any of these concerns? With the increase in the number of manufactured items leading to higher operational rates, and the need to accommodate the expansion of manufacturing lines and diversifying modalities, isn't the type and quantity of buffers required on the rise? The labor required to prepare, store, transport to the process room, and supply buffers to tanks can be reduced. "Innovation in Buffer Supply for Biopharmaceutical Manufacturing" By diluting the necessary amount of buffer inline when needed, buffer preparation can achieve labor savings and space reduction (up to 75%). Furthermore, an increase in productivity per area can be expected!

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The "Allegro(TM) 2D Biocontainer" is made from high-quality film that meets the performance and specifications required in the fields of biotechnology and pharmaceutical manufacturing. As part of a wide range of offerings, capacities are available from 50mL to 50L. It is equipped with various features necessary for single-use systems, including a sample port standard on all sizes, large-diameter ports for sensor installation, and compatibility with a variety of tube sizes to match process flow rates. 【Features】 ■ Shape that allows for efficient fluid discharge ■ Capable of filling to the specified capacity (full) even for applications requiring freezing ■ Inlet and outlet options available in 1/4 to 1/2 inch ■ Sensors can be inserted through the 1/2 inch port ■ Ports designed for connection with cable ties or BarbLock *For more details, please refer to the PDF document or feel free to contact us.

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Unlike conventional Tangential Flow Filtration (TFF), Cadence(TM) single-pass TFF allows for the concentration of target substances without recirculating them. This enables a reduction in the flow path (installation space) and can be used for unstable target substances that are prone to inactivation. Additionally, at the end of the concentration process, only a small amount of product remains in the module, which is characterized by a high product recovery rate. Compared to conventional systems, it is also easy to recover the product without dilution.

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The Palltronic® Flowstar V is a filter integrity testing device that meets the latest regulatory requirements and can perform reliable integrity tests in the filtration sterilization processes of pharmaceutical manufacturing, where sterility assurance is necessary. Developed based on years of experience and extensive expertise, it retains the features of the previous model while being even more user-friendly, with enhanced data integrity and quality risk management functions. [Compliance with Data Integrity and 21 CFR Part 11 Requirements] It is equipped with performance that complies with guidelines on data integrity and electronic signature security from 21 CFR Part 11 and the UK Medicines and Healthcare products Regulatory Agency (MHRA), addressing each requirement. Therefore, it demonstrates reliable performance in the filtration sterilization processes of pharmaceutical manufacturing, where sterility assurance is required.

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This is a virus inactivation system suitable for continuous and batch processes. It accommodates scales from small-scale to commercial production scales of 2,000 L. (※Conditions for compatibility need to be confirmed.) To minimize the operator's burden, it is a fully automated system capable of continuously performing low pH virus inactivation treatment. Additionally, it is possible to record the data for pH adjustments. Depending on the application, one or two Allegro(TM) single-use mixers (sold separately) can be connected. A mixing system and recirculation loop are employed to synchronize them to function alternately, allowing one system to perform virus inactivation under low pH conditions while the other collects and retains the process liquid.

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The "Mustang(R) S Chromatography Capsule" was developed for the recovery and adsorption removal of biomolecules with a positive charge through cation exchange in bioprocess purification processes. Due to its high flow rate, it allows for large-scale processing within a single day's work. It is suitable for the recovery of biomolecules in the early stages of the purification process and for the removal of positively charged impurities in subsequent purification steps. 【Features】 ■ Biomolecules with a positive charge easily bind in a single pass ■ High flow rate enables large-scale processing within a single day's work ■ Ready to use and can be sterilized in an autoclave ■ Capsule or cartridge format ■ Compared to conventional columns that require packing and cleaning validation, it reduces operational costs and capital investment *For more details, please refer to the PDF document or feel free to contact us.

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The CleanPack(R) Presto Sterile Connector is a sterile connector that does not distinguish between male and female. This sterile connector enables reliable sterile connections between flow paths for all applications in biopharmaceutical manufacturing. 【Applications】 - Preparation and transfer of media and buffers - Cell seeding into culture vessels - Sampling during fermentation/cell culture - Recovery of culture medium from culture vessels - Aseptic fluid transfer between units - Probe insertion into culture vessels, mixers, and 3D biocontainers - Connection of filtration sterilization manifolds *For more details, please refer to the catalog or feel free to contact us.

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The "Allegro(TM) 3D Biocontainer" is a single-use bag developed for the storage of large volumes of liquid. It is designed with a focus on high reliability and flexibility, making it very easy to install and handle in the protective tote (receiver container). Additionally, the film used meets the demands of the manufacturing processes for pharmaceuticals, which require high performance. The 3D Biocontainer, which expands the lineup from the 2D Biocontainer, is designed with the latest technology to enhance the robustness of single-use systems, improve operability when handling large volumes of liquid, and increase product recovery rates. 【Features】 ■ Unique design that improves operability ■ Easy and quick installation ■ No need for accessory protection during liquid filling ■ Validation data compliant with regulatory requirements *For more details, please refer to the catalog or feel free to contact us.

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The "Pegasus(TM) Prime Virus Filter" reliably removes viruses, protecting critical biopharmaceutical manufacturing processes from viral contamination and ensuring the quality of pharmaceuticals and safety for health. Delivered gamma-irradiated from small scale to process scale, it features high flow rates and stable filtration performance, enabling process simplification, reduction, and continuous cost savings across a wide range of scales. 【Features】 ■ Stable high virus removal performance regardless of process fluids or parameters ■ Stable filtration performance with high flow rates ■ Gamma sterilized ■ Scalable ■ Constant filtration area ratio of pre-filters to virus filters across all scales For more details, please refer to the catalog or feel free to contact us.

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The "Pall Advanta(TM) II Filter Housing" is a filter housing for liquid and gas filtration that meets sanitary requirements and complies with ASME Bioprocessing Equipment (BPE) standards. This product can accommodate a single open-ended filter cartridge (Pole Code 7 or Code 2) and can be used with four representative flow patterns: - AGT series for gas filtration applications (T flow) - ALT series for liquid filtration applications (T flow) - ALI series for liquid filtration applications (I flow) - AVL series for both gas/liquid filtration applications (L flow) *For more details, please refer to the PDF materials or feel free to contact us.

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