The therapeutic monoclonal antibody is one of drugs of which there are the most expectation in biopharmaceutical industry, and the scale on which monoclonal antibodies are produced is comparable to that of insulin and plasma proteins (several ton per year). To accomodae such production scale, large sized cell culture apparatuses of 12000 L to 15000 L or larger, and several-fold increase from a protein expression level of 0.1 g/L to 1.0 g/L are necessary.
To secure the safety and robustness of the biopharmaceutical manufacturing equipment, single-use equipment, which does not require sterilization and cleaning, is increasingly used across the world. Once single use equipment is introduced, quick start-up of facilities and flexible exchanges of facilities adjusted to the production items and the scale of production are possible. To satisfy these needs, we offer a large variety of single use bioreactors, mixers, and purification equipment, which allow easy scaling up production.
FlexFactory Single-use Bioprocess Platform
Xcellerex XDR single Use Bioreactors
- These Bioreactors are single-use bioreactors with a built in impeller. A wide range of culturing volume of each model allows scale-up of cell culturing from 4.5 L to 2000 L working volume. Basic optinal configurations of accessories make possible accurate monitoring of tank parameters, and these bioreactors are suitable to apply to culturing during biopharmaceutical manufacture.
Xcellerex XDR-50 MO and XDR-500 MO Single-use Fermentor System
- XDR-50 MO and XDR-500 are intended for microbial cultures of up to 500 L working volume
- Microorganism growth performance comparable with conventional stainless steel fermentors
- Robust bag design with No. leakage prone mechanical seals
- Powerfull mass transfer from a high-power input, two stage impeller
- Oxygen transfer capacity that support high density fermentation
- Dimpled, jacketed heat transfer surface for efficient heating and effective cooling
- The adoption of single use technology in fermentation processes has been hampered by the lack of systems capable of accomodating the demands of microbial cultures in terms of mass transfer, mixing, and temperature control
Xcellerex XDM Quad Intelligent Single use Mixing system
Xcellerex XDM Mixers are designed for convenient and efficient mixing buffer, media, intermediates and product, as well as other fluids. The single-use system eliminates the hassle of time-consuming and costly clean-in-place (CIP) and steam-in-place (SIP) procedures, as well as cleaning validation.The result is efficient processing and rapid batch-to-batch turnover time. The Xcellerex XDM Mixer is available in a single-wall stainless steel, jacketed stainless steel (for heating and cooling applications), or polypropylene.
Xcellerex XDUO Quad Intelligent Single-Use Mixing System
Xcellerex Xduo Mixer is an intelligent, plug-and-play, single-usemixing system for clinical and commercial production of biopharmaceuticals, vaccines, and other biologics. The system supports upstream and downstream applications for automated mixing of buffer, media, product and intermediates, as well as other process fluids. XDUO features powerful onboard automation capabilities, including in-line sensing, load cells, and process control, combined with robust mixing and ease of use. XDUO integrates seamlessly with existing biomanufacturing production lines ass well as with the FlexFactoryTM biomanufacturing platform.
Xcellerex XDUO 2500 Single-Use Mixing System
- Xcellerex XDUO 2500 Mixer is a robust, versatile, and easy-to-use 2500 L single-use mixer that can be used for mixing operations throughout the entire bioprocess workflow in upstream as well as downstream bioprocessing.
- Dual impellers amd integrated magnetically coupled drives for faster setup and mixing times.
- Ergonomic and intuitive mixer and bag design contribute to easy handling and accurate bag installation.
- Automation of pH and temperature for higher accuracy and consistency in large-volume mixing operations compared with manual methods
- Integrated in-line sensors eliminate manual sampling and avoid contamination risks.
- Advanced data management allow monitoring, trending, recording, exporting, and printing and is 21 CFR Part 11 compliance-enabled
- Control is performed locally or remotely for Xcellerex FlexFactory (using M-Station) and other biomanufacturing platforms (using X-station), avoiding manual control.
Akta Ready Single Use Chromatography System
This liquid chromatograpphy system configured with exchangeable, disposable flow paths is suitable for contract manufacturing of biopharmaceuticals for clinical trials or multiple-product production, for small-scale manufacture. Simple exchange of the complete flow paths eliminates the need for cleaning validation. Downtime between products/batches is greatly reduced, leading to improved productivity.
Akta Ready XL Manufacturing Scale Single-use Chromatography System
Akta rady XL is a liquid chromatography system designed for manufacturing scale. To meet the capacity demands from single-use upstream processes (2000 L high-titer feeds), the system operates large-scale columns (up to 1200 mm), using the two flow kit sizes that cover a broad range of flow rates from 45 to 3500 L/h. The single-use flow path minimizes the need for cleaning and cleaning validation, allowing for quick changeover between productions, while eliminating the risk of carryover. AKTA ready XL offers the accuracy and documentation required for use in a GMP-regulated environment
Akta readyflux is an automated single-use filtration system for pilot- and a small- scale manufacturing. The system is intended for crossflow (also called tangential flow) filtration applications in both upstream and downstream workflows.
- Easy method preparation and flexible automation methods require no programming expertise and free up time for other activities.
- Quick installation of single use flow path (incl. Sensors) reliably guided using installation wizard.innovative and compact design with minimun recirculation volume for high concentration factors and product recovery.
- Flexible use of both filter cassettes and hollow fiber filter cartridges for microfiltration and ultrafiltration operations.
- ReadyMate Flow Kit, together with ReadyToProcess hollow fiber cartridges, enabled closed system opeprations
AKTApilot 600 S/R
AKTA pilot 600 is a bench-top chromatography system well-suited for both GMP and non GMP work. The wide flow and pressure range allows both production of technical batches and scale up studies as well as small scale production of GMP-grade material.
The product is available in two versions, AKTA pilot 600s and AKTA pilot 600r. The 600s model is suitable for non-GMP environments whereas 600r is suitable for GMP environments. Both versions can be modified to fit specific needs thanks to the modular design.
Experience compact scalability
- Speed up projects through easy handling and change over
- Match product yield project needs
- Access wide scalability both within and between systems
- This system provides ten thousands of configuration possibilities, and post installation modification is also possible.
- Remote monitoring and control by means of an external system is possible
- Seamless scaling up
- Delivery period of two to three months
- FDA 21 CFR part 11 compliance is supported
- UNICORN software automatically optimizes the cross flow filtration conditions.
- The system can be used with hollow fibers and flat sheet cassettes
- For the applications of concentration, diafiltration, and clarification.
- Sanitary design of the lower volume of circulation liquid and residual volume of fluid volume
- FDA 21 CFR Part 11 compliance is supported
This is an innovative system that enables automatic optimization of operating conditions, such as TMP, in the cross flow membrane steps. Finding an optimal operating condition at the stage of process development is expected to lead to improved economy after scale up.
ÄKTA Flux Series
- For the applications of clarification of chromatography samples, concentration of biomolecules, desalting, and buffer exchange.
- Semiautomated filtration process due to automated end-point control
- Module exchange allows the use of either flat sheet cassettes or hollow fiber cartridges.
Using either flat sheet cassette or the hollow fiber cartridge, samples to be purified by column chromatography such as cell culture solutions, can beconcentrated or desalted within shorter times. This system is suitable when concentration or diafiltration of large volumes of sample before filtration by column chromatography is time-consuming, or for desalting by gel filtration. Automated end-point control allows effortless filtration, and touchscreen displays enable intuitive operations