Biostat® RM and Flexsafe® RM Bags

Biostat® RM Rocking Motion 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, NS0, Sf9, E. coli, 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 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.

Accelerating go-to-market timelines

A modular solution that eliminates the need to acquire new equipment for different workflows.

Simplifying process transfer from PD to CM

Same equipment and automation platform offering for process development & commercial manufacturing.

Flexibility for different production scenarios and testing multiple setups

Multiple configurations via same rocker platform with a 20 L or 50 L tray and Flexsafe® RM bags.

Precise process control for better parameter definition

Biobrain® automation platform with the broad range of single-use BioPAT® sensors.

Excellent global application support

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.

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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

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

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

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

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.

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icon-seed-expansion-biostat-rm-rocking

Switch Between Different Production Scenarios

Simplified process transfer from basic to intensified operation with a change of the Flexsafe® RM bag

Get Ready to Intensify

Seamless Streamlining of Bioprocess Scale-up

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) 


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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.

icon-cell-culture

Regenerative Medicine

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.

icon-vial-syringe

Vaccines

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.

icon-mab-cell

mAbs

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.

FAQs - Biostat® RM & Flexsafe® RM

A rocking mortion 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 waxe 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.

Learn More About Biostat® RM

Related Assets

White Paper

Adopting a Platform Approach to Upstream Processing Increases the Speed to Clinic of New Biopharmaceuticals

PDF | 427.7 KB
Datasheet

Biostat RM Rocking Motion Bioreactor Powered by Biobrain®

PDF | 447.4 KB
Datasheet

Flexsafe® RM Disposable Cultivation Chambers for Rocking Motion Bioreactors

PDF | 927.2 KB

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Patents

CountryPatent number

US

US 6,673,532 B2

US 7,041,493 B2

US 8,304,231 B2

US 6,673,532 B2

US 9,017,997 B2 

Europe

EP 1 309 719 B1

EP 1 778 828 B1

EP 2 268 788 B1

EP 2 945 978 B1

EP 2 945 801 B1

China

CN104995239B

CN104995029B

Japan

JP6362620B2