Cytiva List of Products and Services

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.

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.

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.

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.

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.*

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.

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.

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.

Paul has contributed to the establishment of many current standards regarding filter validation of critical processes and the use of single-use systems, based on over 40 years of experience in validation support. Moving forward, we will continue to be at the forefront of development to support the adoption of new technologies such as continuous production. We provide professional consulting and testing services while safeguarding our clients' highly confidential information. 【General Testing】 ■ Bacterial Challenge Testing ■ Compatibility Testing ■ Consulting on Extractables ■ Extractables and Leachables Testing ■ Leachables Reduction (Flushing) Testing ■ Integrity Testing Factor Setting with Pharmaceutical Solutions *For more details, please refer to the PDF materials or feel free to contact us.

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.

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).

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.

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!

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.