Biostat® RM Bioreactor Powered by Biobrain®
Engineered for Simplified Scale-Up
The Biostat® RM is a GMP compliant, wave-mixing bioreactor. It is paired with single-use Flexsafe® RM bags and is proven for a broad range of different cell lines incl. CHO, HEK293, stem cells, and CAR-T cells. Especially, customers working with shear-stress-sensitive cell lines and bioconjugates acknowledge benefits of the rocking motion technology.
The modular concept of the Biostat® RM portfolio, ranging from 2 L to our unique 200 L, provides flexibility to manage your individual process needs. Biostat® RM saves space, reduces costs, and increases yields. In addition, Biobrain® - the commercial manufacturing-ready automation platform shared between Biostat® RM and Biostat STR® - enables a seamless transfer from product development to manufacturing scale. This makes the Biostat® RM an integral part of the intensified seed train.
To meet the demands of the dynamic biopharmaceutical industry, we discuss the value of rocking motion bioreactors as part of your seed train strategy from process development to commercial manufacturing.
In this webinar, Sartorius experts present the latest PI technologies, including advanced Biostat® bioreactors integrated with PAT functionality controlled by the Biobrain® automation platform.
A modular solution that eliminates the need to acquire new equipment for different workflows.
Same equipment and automation platform offering for process development & commercial manufacturing.
Multiple configurations via same rocker platform with a 20 L or 50 L tray and Flexsafe® RM bags.
Biobrain® automation platform with the broad range of single-use BioPAT® sensors.
Round the clock customer support that includes optimization, maintenance, and qualification.
Platform Components
A Biostat® RM System Consists of Three Elements: Control Tower, Rocker & Flexsafe® RM Bags
The Biostat® RM rocking motion bioreactor system consists of a new, first-in-class control tower built upon the commercial manufacturing-ready Biobrain® automation platform and existing selection of rockers paired with a variety of Flexsafe® RM bags.
Single-Use Bags
Proven for a broad range of different cell lines
Sterile cultivation chamber for various cell lines with multiple build-in control measurements for proper growth conditions
- One Flexsafe® film through whole production process for simplification of product validation
- Optical bags with single-use pH, DO and viable biomass sensors
- Perfusion bags with integrated perfusion membrane or ATF port
Sensors & Analyzers
Precise process control for better parameter definition
The advanced analytics that are a part of the Biostat® RM portfolio ensure defined parameters are met throughout setup and scale up for tight process control.
- Biobrain® automation platform with fully integrated sensors and analyzers ensures easy process setup
- Achieve advanced parameter definition through unique off-the-shelf Process Analytical Technology (PAT) and control
- Leverage the broad solution of single-use sensors, such as pH, DO, capacitance and conductivity, with BioPAT® Viamass or glucose and lactate with BioPAT® Trace
Control Tower
Variety of controllers and actuators for flexibility in process set up
Provides and maintains necessary cultivation conditions, e.g. pressure, temperature, gassing, rocking angle and biocapacitance.
- Control tower fulfills commercial manufacturing norms and regulations, such EN 60204, EN61010, IP 54, CE and UL
- Validated usability in the clean room environment (VHP)
- Possibility to interface to SCADA and DCS systems
Rocker
Modular solution enables flexible work spaces
One rocker platform can be used either with a 20 L or 50 L tray, as well there is a separate 200 L platform. Working volumes range from 100 ml and up to 100 L with Flexsafe® RM bags (e.g., basic, optical, or perfusion configurations)
- Biostat RM® Rockers are available in different versions: Biostat® RM 20|50 or Biostat® RM 200
- Wave-motion provides optimal environment for suspension cell culture.
- Weight measurement integrated in rocker
- Monitors the fill level of bag precisely, even during rocking
- Space-saving
Explore Our Range of Flexsafe® RM Single-Use Bags
Flexsafe® RM Single-Use Bags
Bag Size | Min. Working Volume | Max. Working Volume (L) | Surface Area |
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1L | 0.1 | 0.5 | 127296 |
2L | 0.2 | 1 | 172260 |
10L | 1 | 5 | 303360 |
20L | 2 | 10 | 633080 |
50L | 5 | 25 | 985320 |
100L | 10 | 50 | 1421724 |
200L | 20 | 100 | 2777064 |
Total Volume (L) | 1 | 2 | 10 | 20 | 50 | 100 | 200 |
Working volume (L) | 0.1-0.5 | 0.2-1 | 1-5 | 2-10 | 5-25 | 10-50 | 20-100 |
Bag Types | |||||||
Basic |
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Basic with screw cap |
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Basic with Viamass |
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Optical |
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Optical with screw cap |
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Optical with Viamass |
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Perfusion with integrated membrane |
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Perfusion with connection to ATF |
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Perfusion with Viamass |
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Adapts to Evolving Seed Train Strategies
One Production Seed Train for Classic Fed-Batch or Intensified Processes
The Biostat® RM is an integral component of seed trains for commercial manufacturers. By using the Biostat® RM 200 bioreactor in intensified mode with the corresponding Flexsafe® RM bags, biomanufacturers can reduce production bioreactor culture days by up to 20% using high inoculation and maintaining titer. The Flexsafe® RM and Flexsafe STR® bags also use the same film, streamlining validation.
Effortless End-to-End Scalability from 2 L to 200 L volumes
The Biostat® RM portfolio offers customers a simple scalability solution by using only 2 rocker platforms for a variety of Flexsafe® RM bags from 2 L and up to 200 L in basic, optical and perfusion configurations. Both types of rockers share the same control tower based on the Biobrain® automation platform, further eliminating the possibility for human error and device incompatibilities.
Saving Space and Time With Unique 200 L Rocker Design
The Biostat® RM portfolio helps streamline process transfer between product development and manufacturing thanks to the unique Biostat® RM 200 rocking motion bioreactor which meets commercial manufacturing regulatory norms and requirements. RM 200 does not use submerse gassing or stirrer elements, thus provides a gentle environment for all cell types, especially shear-stress-sensitive cell lines.
Biobrain® Automation Platform
Seamless Transfer From Development to Commercial Scale
A single automation platform that is shared between Biostat® RM and STR® bioreactor families and supports scalability from Process Development to Commercial Manufacturing. It offers the flexibility to quickly and easily configure the system to meet precise process needs.
- GMP standalone capabilities
- Local recipe execution (ISA88)
- Flexible automation solution
- Benefit from native connectivity to BioPAT® MFCS4 for enhanced process automation and control
- Interfaces to historians, SCADA, and DCS
- Based on industry standards & components
- Reduced time-to-facility
- Ease-of-use (common HMI)
Enhanced Support and Transparency
Interface Consulting supports clients by offering consultation and providing documentation for the integration of Biobrain® standard instruments and/or BioPAT® MFCS. This service reduces effort and risk while accelerating system integration.
The Advanced Order Execution (AOE) service provides a dedicated project coordinator (remotely) for standard instrument orders. The coordinator supports with scheduling, monitoring order progress, facilitating communication, and granting early access to all available documentation through SharePoint. These enhancements improve customer interaction and provide greater visibility to the customer.
Applications
Flexibility to Accommodate Rapidly Changing Processes
Biostat® RM provides the flexibility to manage multiple molecules in the pipeline. It is ideal for customers that are working on the commercialization of sensitive molecules or for customers working on advanced techniques for the commercial production of proteins using intensified or continuous processes.
For mild culture of shear-stress-sensitive cell lines
Regenerative therapeutics repair, replace and engineer human cells, tissues and organs to restore normal function, and may soon address a significant unmet need. Given the sensitivity of stem and T-cells/CAR-T cells, rocking motion bioreactors are a logical choice for production.
Sartorius collaborates with customers to integrate Biostat® RM bioreactors and Flexsafe® RM bags into cultivation and expansion processes, leveraging BioPAT® capabilities inherent in Sartorius single-use systems.
For end-to-end single-use processing from PD to CM
Sartorius technologies are ideal for the production of viral vaccines, vectors and gene therapies, with end-to-end, single-use processing from process development through commercial manufacturing at the 2,000 L-scale. Rocking motion bioreactors, known for ease-of-use and affordability support seed cultivation and cell expansion steps, as well as the inoculation of production bioreactors. Sartorius single-use technologies and associated services help meet the needs of vaccine manufacturers.
For ease of use, cost effectiveness and desired cell densities
Wave-mixed, single-use bioreactor technology is well established in monoclonal antibody production for its cost effectiveness and ease-of-use when scaling-up from 1 L and up to 100 L working volumes. When paired with Flexsafe® RM bags in basic, optical and perfusion configurations, rocking motion bioreactors achieve desired cell densities under the tight control of BioPAT® technology and offer flexibility for different processes using the same rocking motion platform.
Learn More About Biostat® RM
FAQs - Biostat® RM & Flexsafe® RM
A rocking motion bioreactor is based on the wave mixed technology. It does not use submerse gassing or stirrer elements, providing a gentle environment for all cell types, but especially for shear-stress-sensitive ones.
The oxygen transfer and mixing are accomplished by the principle of wave-induced motion.
This type of bioreactor is based on wave mixed technology. It does not use submerse gassing or stirrer elements, providing a gentle environment for all cell types, but especially for shear-stress-sensitive ones.
The oxygen transfer and mixing are accomplished by the principle of wave-induced motion.
There's no difference. Both methods stand for a controlled cultivation of shear-stress-sensitive cell lines and bioconjugates.
The Flexsafe® RM bag is a disposable bag optimized for cell cultivation. It can be equipped with different measurement methods, such as optical pH and DO probes or viable biomass measurement (BioPAT® Viamass port). Furthermore, a perfusion membrane can be integrated.
Rocking motion mixing technology is ideal for cell cultivation with low shear stress. It is hassle free and applicable to all cell types, including mammalian cells, plant cells, insect cells and microbial cells.
Yes, it is well suited for process intensification (e.g., Seed Train Intensification (N-1 Perfusion), High Cell Density Cell Banking). The advanced process control by BioPAT® sensors like BioPAT® Viamass & BioPAT® Trace allows an easy set-up of permeate and bleed flow. The integrated weight control of the rocker and the gravimetrical control of substrats ends in an advanced process control.
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