Commercial Manufacturing with Biostat STR® Generation 3 featuring Biobrain® Automation

The Biostat STR® Generation 3 single-use bioreactors come with the GMP compliant automation platform Biobrain® and a comprehensive suite of analytical tools.  Ready for process intensification through integrated Repligen XCell ATF® Technology, the Biostat STR® can help enhance productivity, reduce footprint and lower COGs of your facility. The system can be used fully standalone or easily integrates into existing automation infrastructures and consistently delivers outstanding performance, quality, and productivity – supporting manufacturers as they bring safe, effective, and affordable life-changing biopharmaceuticals to market.

Stay flexible and optimize space

The modular design offers adaptability and reduces footprint while Media Control Hub organizes and saves space.

Reduce operating expenses

Single-use saves time and costs with faster turnaround, shorter changeovers, and less cleaning.

Minimize risk

Flexsafe STR® bags are robust, biocompatible, and can be used with the Sartocheck® 4 Plus Bag Tester.

Achieve superior process control

Recipe execution on Biobrain® and advanced process control with BioPAT® sensors ensure precision.

Improve productivity and ease of use

Single-use technology with integrated sensors and easy-to-install Flexsafe STR® bags save setup time.

Configurations & Components

Biostat STR® Generation 3 Configurations

Our Commerical Manufacturing solutions have been predesigned into two configurations with flexible options and easy upgrades. Select the configuration that best fits your current needs and can conveniently adapt to any future requirements.


Feature

Essential

Performance

Integrated Repligen XCell ATF® Technology

o

Media Control Hub for organizing pumps, balances, and feeds

o

Bagholder Surface Ra < 1.2µm, improved over previous model

 

 

pH and DO Sensor Redundancy (up to 4x pH + 4x DO)

o

o


Process Analytical Technologies (PAT) Toolbox 

BioPAT® Trace glucose/lactate sensor

o

BioPAT® Viamass sensor for real-time viable cell density

o


Advanced Process Control

Vessel Level Control

 

 

Gravimetric Feeds

2

Up to 5

Viamass Cell Bleed/Feed Control

o


Automation

Meets GMP standards GAMP 5, ISA 88 and OPC UA

 

 

Local Data Archive, Historical Trending & Batch Reporting

 

 

User Management & Audit Trail

 

 


Safety

IP Rating: IP65/NEMA 4x (Tower); IP54/NEMA 12 (Bagholder)

 

 

BioPAT® Foam single-use sensor with High Foam Alarm

o

Bag Lifting & Installation Device for 500 L, 1,000 L, and 2,000 L

o

o

Sartocheck® bag tester

o

o

 

Notes:   - Always Included, o - Option

Explore the Platform Components

The Biostat STR® Generation 3 Release 2 expands on the original Generation 3 STR with the addition of fully integrated XCell ATF® Technology, Media Control Hub, and Biobrain® software features for GMP and recipe execution.

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Adaptability for Diverse Processes

The stainless-steel bag holders host the single-use Flexsafe STR® bags across all sizes from 50L to 2,000L.

The bag holders are fully interchangeable with the control tower to flexibly adapt to changing process requirements by switching bag holder size

  • Full jacket for optimal temperature control
  • Integrated load cells and gas supply
  • Improved Surface Finish (< 1.2 µm for improved cleanability in CM applications
  • Bag lifting device available for simplified 500 L, 1,000 L and 2,000 L Flexsafe STR® bag installation

Superior Process Control

The control tower runs on Biobrain®, our automation platform to manage all process steps.

The control tower’s intuitive user interface Biobrain® enables advanced process control and automation while making bioreactor operation more streamlined.

  • The control tower can be used interchangeably with any bag holder size.
  • Easy configuration changes to meet changing process needs without additional hardware modifications
  • GMP compliant with audit trail, user management, batch reporting and more

Improving Productivity & Minimizing Risk

Flexsafe STR® single-use cell culture bags deliver increased cell viability and higher cell density.

Flexsafe STR® bags are fully configurable to fit your process needs with multiple options for impeller, sparger and BioPAT® sensor technologies.

  • Integrated single-use sensors for optical DO and pH, electrochemical pH as well as BioPAT® Viamass
  • Multiple sparger and impeller options on a magnetically coupled center-line shaft
  • Full control of the supply chain from raw material to bag assembly ensures superior quality and consistency

Excellent Organization & Connectivity

The Media Control Hub simplifies the set-up of complex feed strategies by providing storage and connectivity for pumps and balances.

It has a footprint of only 0.8 m2 but offers up to 3.2 m2 storage area. Pumps and balances can be connected directly to the Hub and controlled through Biobrain® at the control tower. Various accessories for organization of tubes and cable help maintain an organized workspace.

  • Adjustable shelves and versatile cable and tubing management.
  • Data and power connection for pumps and balances directly on the hub
  • One data connection cable to the STR control tower & one electrical power connection to the mains supply

Simplified Perfusion Processes

The Biostat STR is available with fully integrated XCell ATF® Technology (ATF control hardware & software) for intensified processes.

This integration simplifies perfusion processes and ensures process intensification is faster, easier and more efficient. Installation, qualification, training and operation are more streamlined.

  • All required hardware for control of XCell ATF® device fully integrated in the bag holder
  • Operation of the XCell ATF® Device is done through the Biobrain® interface, no need for a separate control unit
  • Easy and flexible set-up of intensified processes.

Focus On Enhanced Capabilities

Adapt to Every Process

The Biostat STR® Generation 3 system is fully configurable to meet even the most demanding process needs. The modular design makes upgrades easy with simple software and hardware changes, giving biomanufacturers maximum flexibility.  

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Increase Facility Throughput

The Biostat STR® Generation 3 is ready for process intensification, increasing your facility’s potential. Full integration of Repligen XCell ATF® Technology eliminates the need for additional control hardware and simplifies perfusion process setup and control.  

  • Simplify with fully integrated XCell ATF® Device – meaning control seamlessly embedded into the Biobrain® automation platform
  • Automate cell bleed and glucose feed control with BioPAT® Viamass and BioPAT® Trace
  • Connect cell retention devices and advanced sensors to highly configurable Flexsafe STR® bags

Maintain Real-Time Monitoring

From viable cell mass to off-gas analysis, enhance process understanding and control through BioPAT® sensor technologies. BioPAT® sensors enable sophisticated process monitoring for the Biostat STR® online and in real time.

  • Analyze viable cell mass and gain advanced feed and bleed control with BioPAT® Viamass
  • Measure glucose and lactate concentration and automate nutrient feeds with BioPAT® Trace
  • Analyze oxygen and carbon dioxide concentrations with BioPAT® Xgas for precise understanding of culture metabolism
  • Monitor foam level in the bioreactor with BioPAT® Foam, knowing alarms will notify of potential filter blockage

Keep the Workspace Clean

The Media Control Hub organizes feeds, pumps and balances to automate complex processes while maintaining a clean and efficient workspace.  

  • Tap into power and data connectivity for pumps and balances at the Media Control Hub
  • Monitor pump control and balance read-out through the Biobrain® interface at the control tower
  • Organize accessories such as cable guides and tube holders for a clean process setup
  • Optimize space through small footprint

Biobrain® Automation Platform

Control and Automate Every Process

The Biostat STR® 3 runs on Biobrain®, a GMP-compliant automation platform enabling advanced process monitoring and control.  

  • Comply with industry standards GAMP 5, ISA 88 and OPC UA
  • Be GMP-ready with one year of data storage, archiving, audit trail and batch reporting
  • Execute automated processes with local recipe control based on ANSI-88 compliant process automation
  • Benefit from native connectivity to BioPAT® MFCS4 for enhanced process automation and control
  • Interface with your data historian, external SCADA, or DCS systems  
  • Enjoy ease-of-use with the modern, intuitive Biobrain® HMI


Consult Our Experts

Supportive Software

Data Driven Software Applications to Improve Productivity

Biostat STR® is available with a comprehensive suite of advanced analytical tools and data-driven software, including BioPAT® MFCS software for enhanced process automation and SIMCA® for advanced multivariate data analysis. The recently launched BioPAT® Process Insights software offers simplified, predictive bioreactor scale-up and scale-down to reduce risk and development timelines.

Monitor Your Process Data

BioPAT® MFCS4 is the SCADA software for reliable data acquisition, monitoring, and control in bioprocess applications. It provides flexible plug-and-play connectivity with Biostat STR® 3 and offers calculations, sample logging, trend monitoring, and advanced recipe control.

Explore BioPAT® MFCS4

Discover Trends in Your Process Data

SIMCA® Multivariate Data Analysis software is the benchmark data analytics tool for scientists, engineers, product developers, and others striving to gain information from massive quantities of complex data. SIMCA®-online monitors production processes in real-time to give early warning of process anomalies that could affect the final product.

Explore SIMCA® MVDA Software

De-Risk Parameter Transfer Workflow

BioPAT® Process Insights software provides biomanufacturers with predictive scaling capabilities to help mitigate risk and shorten timelines. Powerful modelling of process parameters is supported by extensive bioreactor characterization data from Ambr® 250 to Biostat STR® 2,000 L.

Explore BioPAT® Process Insights

Learn More About Biostat STR® Gen 3

Featured Assets

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The Concept of Upstream Scaling: From Theory to Practice

Join our technical product experts in reviewing real-world case studies of successful scale-up, using novel single-use technologies

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Webinar: BioPAT® Process Insights Software Product Launch

Learn about a new standalone software application that can simplify and de-risk scaling

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Related Assets

Brochure

Biostat STR® Generation 3 and Biobrain® Automation Platform for Process Development

PDF | 687.7 KB
Poster

A Rapid, Low-risk Approach for Process Transfer of Biologics from Development to Manufacturing Scale

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Consult Our Experts

Consult Our Experts