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Fermentors
Bioreactors
- Mobius® Bioreactors
- Product Detail
- Company Profile
- Mobius® Bioreactors are a scalable portfolio of stirred tank bioreactors that provide flexibility by configuring software, hardware, and single-use assemblies for use in suspension and adherent cell culture applications.
Our bioreactor platform has been designed to ensure that ease-of-use and operational flexibility at small scale can be translated to full-scale production.
Benefits
Installation of single-use assemblies designed with you in mind for safe and repeatable operation
5:1 turndown ratio provides you with the most flexible seeding and growth strategy
Works as a standalone system or integrated as part of your facility’s automation platform
Demonstrated scalability of key engineering parameters gives you confidence to scale up your process
Lynx® Connectors assure a critical sterile connection
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| Mobius® 50 L Bioreactor | Mobius® 200 L Bioreactor | Mobius® 1000 L Bioreactor | Mobius® 2000 L Bioreactor |
Consistent process engineering characteristics that provide easy and reliable scale-up
Mobius® Bioreactors follow a Quality-by-Design approach, providing end-users with a clear characterization of key engineering parameters, including power input per volume, mixing time, oxygen transfer capabilities and temperature mapping across all scales of the portfolio.
Our characterization of the key engineering parameters, coupled with consistent scaling ratios, gives you confidence that this system will match your process needs for adherent or suspension cell culture. Each Mobius® Bioreactor is characterized at the minimum (20%) and maximum (100%) working volumes from 10 L – 2000 L, providing the true operational flexibility needed from laboratory to production scale.
Intuitive, ergonomic operations
Mobius® Bioreactors have been designed to provide intuitive and ergonomic operator interactions that simplify workflow at all scales. Each system is comprised of a vessel, Flexware® assemblies and a control box containing mass-flow controllers (MFCs), pumps, a human machine interface (HMI) and optional Common Control Platform® (CCP®) software.
The 50, 200, 1000 and 2000 L Mobius® Bioreactors are all fully jacketed to optimize heating and cooling steps. All systems have doors and viewing windows, providing easy access to expendables and visibility on the status of the working volume and mixing steps. Additionally, they all have integrated load cells for precise volume monitoring and a 2:1 aspect ratio.
Full-scale production with an innovative twist
Since handling single-use assemblies above 1000 L can be cumbersome, the 1000 L and 2000 L bioreactors have additional features that optimize the experience for the operator, including a vessel drawer, allowing the easy installation and removal of Flexware® assemblies. With the ability to self-deploy and self-deflate using air, the EZ-Fold feature of the Flexware® assembly assures ease-of-use and safety for the operator.
In the absence of a baffle, a bottom-mounted impeller can result in the formation of a vortex during mixing. The presence of a vortex, especially at the large scale, can result in zones that are not completely mixed. To overcome this issue, the Mobius® Bioreactor benefits from an internal baffle resulting in homogeneous mixing in under a minute at low power input.
In addition, the bottom-mounted impeller maintains gentle agitation during the clarification step down to the minimum working volume without generating foaming and reduces the time by delivering a consistent harvest to your clarification system. Dual sparger options, microsparger and open pipe, provide process flexibility. The microsparger is located directly under the impeller to promote the dispersion of bubbles and provide maximum mass transfer of oxygen (kLa).
The open pipe, located adjacent to the impeller, is efficient at delivering macro-bubbles. It can be used on its own or in combination with the microsparger to provide increased process control capabilities such as macro-bubble oxygen delivery, addition of carbon dioxide for pH regulation or as a tool to strip carbon dioxide.
Temperature management is another critical requirement for successful cell culture. Temperature profiles of our Mobius® Bioreactors have been fully characterized at minimum and maximum working volumes to give you confidence that your process can be controlled during all steps of the cell culture run.
Common Control Platform® (CCP®) software for multiple-unit operations
From Mobius® Bioreactors to clarification, chromatography, tangential flow filtration and virus filtration, CCP® software can provide you with one familiar interface that simplifies software management and reduces the learning curves of new operators.
This software package is available to support all application sizes, accelerating tech transfer and scale-up of your process.
Optimized for cell culture
The user interface, common across multiple unit operations, brings our process know-how into your hands. The home screen is optimized for the Cell Culture unit operation with easy access to all of the relevant information needed to control your process. Procedures can be automated into recipes, and operators can adjust and optimize control loops in just a couple of clicks.
Monitors processes and enables batch reporting
Create process operations using the recipe editor, monitor the process in the home screen, and create reports for the batch using the confi report generator.
Comprehensive and secure data acquisition
CCP® software was designed to support compliance to 21 CFR part 11 and developed under GAMP5 guidelines; the software includes an accessible audit trail and electronic signatures for verification. CCP® software is designed for development to large-scale manufacturing equipment, and uses industrial computers and controllers for reliability.
Network integration
Data transfer to the plant control system or historian enables data collected by CCP® software to be centrally stored and managed.
Backup and restoration
Backup and restoration of data can also be managed via network integration.
Security synchronization
Security synchronization allows user accounts to automatically coordinate with the networked plant control system for faster and simpler user account control and editing.
Innovative and flexible process monitoring
The Mobius® SensorReady technology is used to monitor and control all sizes of Mobius® Bioreactors, providing you with absolute confidence in the reliability of your control strategy. The Mobius® SensorReady assembly is attached via a sterile connection to
the bioreactor using Lynx® S2S Connectors. The modular, easy-to-operate design provides the user with ultimate flexibility to monitor and control the bioreactor processes, allowing users to incorporate new sensing technologies as they become available without changing the design of the Flexware® assembly.
Extensive characterization has been performed to demonstrate that the readings in the Mobius® SensorReady assembly are representative of the bulk cell culture environment.
Flexware® Assemblies
Flexware® assemblies are designed for maximum operational flexibility, ergonomic usability and operational safety. All sizes of the Flexware® assemblies have an off-centered bottom-mounted magnetic levitating impeller with internal baffles, a turndown ratio of 5:1, and integrated pressure sensors with lines for primary and backup vent filter assemblies comprised of the hydrophobic Opticap® XL5 capsule with Aervent® membrane to prevent overpressuring the assembly.
The 50 L and 200 L bioreactors are constructed of Pureflex® film. At 1000 L and 2000 L volumes,
Pureflex® Plus film is employed for added robustness. The two films have identical product contact layers, maintaining consistent extractables profile and gas barrier properties.
To improve operational safety and ease-of-use, all weldable tubes are labeled for easy identifi and all assemblies have a unique layout ensuring correct fi in the jacketed vessel. The 50 L and 200 L Flexware® assemblies have rigid bases that make installation safe and easy, minimizing any chance of stretching, tearing or damage to the Flexware® assembly. 1000 L and 2000 L Flexware® assemblies feature EZ-Fold technology, which allows for automatic deployment utilizing the on-board MFCs. The Flexware® assemblies provide two sparging options using either open pipe or Microsparger (Tyvek® with grid).
Figure 2. Mobius® 200 L Bioreactor process container with rigid base and “keyed design”
Mobius® SensorReady Dual and Quad Reusable Assemblies
Designed to accommodate conventional probes 100 x 120 mm in length with PG13.5 fittings.
Available sampling options:
Closed-loop sampling option fitted with weldable C-Flex® tubing line capped and designed for sampling via welded connection.
Two sample ports fitted with needle-free swabable valves.
Comprehensive services and support
Implementation services
Our field service engineers have unique internal knowledge of the equipment and years of experience. Qualification and service of our equipment is a core competency. Save time and lower costs by using standardized services executed by trained engineers.
Benefits of our service engineers:
Unrivaled access to parts, system designers, application scientists, and testing equipment
Up-to-date training, service protocols and practices
A global installed base gives us the best understanding of the equipment, and helps you save costs with standardized protocol development
Installation and qualification
Our qualification services ensure that all specifications are met from design and manufacture through to installation and operation. We use a standardized, risk-based approach to ensure nothing is missed, maintain consistency between tests, and maximize efficiency.
Repeated testing is done based on risk to balance efficiency and safety
Our engineers are trained on our products and save valuable time on qualification and documentation
The IQ/OQ protocol and final report provided are compliant with cGMP requirements
Operator training
Designed for pharmaceutical and biotechnology manufacturing personnel who operate upstream processing equipment, our interactive course provides an overview of the Mobius® Bioreactors. Installation of Flexware® assemblies and upstream CCP® software use are also described and practiced in hands-on sessions. To satisfy cGMP requirements, course graduates will receive a certificate upon completion.
With us as your guide, your operators will be better prepared to operate and manage your Mobius® Bioreactors with greater confidence.
CCP® recipe creation service
Every process is unique and, to ensure that your system is optimized to deliver the best performance, our biomanufacturing engineers will translate your process into your own CCP® software recipe in order to maximize the performance of your bioreactor system within your process.
CCP® software training
If your system will be used in process development and needs to adapt to varying process characteristics, our biomanufacturing engineers can also provide you with specific training, including a hands-on session, so that you are able to create and manage your own recipes and system.
Support for performance qualification
Performing the qualification of your whole process with new equipment can be challenging. To help with this step, our biomanufacturing engineers can assist you with targeted advice, in order to allow you to focus on your own process.
The support includes one on-site visit by a trained biomanufacturing engineer to assist you while you perform your qualification, preparation of the equipment, dry run your process recipe, and support for real run during the qualification, for which you will remain the owner.
Preventive maintenance
Preventive maintenance delivers the most cost-effective approach to ensure consistently reliable performance of your Mobius® Bioreactor. Regularly scheduled maintenance of your Mobius® Bioreactor significantly reduces potential downtime and costly repair.
Cell culture media
When you choose us as your cell culture media supplier, you benefit from optimized media formulations, high-quality raw materials, consistent, homogeneous deliveries, and documentation for faster time to market.
Cellvento® CHO medi platform for top performance in cell culture
Our Cellvento® CHO platform provides you with process and cell-line specific cell culture media and feeds – so that you can find the most suitable product for your application.
Benefits
High media consistency and reliable homogeneity
Superior cell growth and productivity
Flexibility on specific nutrient cell type requirements
Flexibility in application: batch, fed-batch and perfusion
Comprehensive documentation for faster time to market
Customized cell culture media
With our extensive in-house formulation knowledge, we are able to design reliable, robust media for your specific processes according to your recipe and create innovative solutions that can enhance the consistency and efficiency of your processes.
Our cGMP facility enables smooth transitions from pilot to commercial-scale cell culture production. We also apply our resources to assist you in troubleshooting and optimizing your media and processes.
Regulatory support and documentation
To facilitate full traceability, our raw materials are subjected to a defined qualification process before being released as suitable for cell culture media production. All materials are carefully screened and selected to confirm their non-animal origin. We also provide comprehensive regulatory information on the manufacture, characterization and control of our cell culture products.
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