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

The Biostat STR® Generation 3 single-use bioreactors and the Biobrain® automation platform with a comprehensive suite of analytical tools, accelerating process development and supporting seamless scaling to commercial manufacturing. The system can be used stand-alone or easily integrates into existing automation infrastructures and consistently delivers on speed, process control, and productivity. Additionally, BioPAT® Process Insights software simplifies Sartorius bioreactor scaling to reduce risk and development timelines.

Improve productivity and ease of use

Reduce time spent on process transfer with SU technology, integrated sensors and Flexsafe STR® bags.

Stay flexible and optimize space

Modular design& interchangeable bag holders offer flexibility while Media Control Hub saves space.

Simplify set-up for process intensification

Repligen XCell ATF®, BioPAT® Viamass & BioPAT® Trace run by Biobrain supports easier intensification.

Increase speed to clinic and market

Simplify tech transfer and ensure consistent results during scale-up from 50 L to 2,000 L.

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

Key New Features

Integrated Repligen XCell ATF® Technology

o

Media Control Hub for organizing pumps, balances, and feeds

o


Process Analytical Technologies (PAT) Toolbox 

BioPAT® Trace glucose/lactate sensor

o

BioPAT® Viamass sensor for real-time viable cell density

o

BioPAT® Xgas sensor for real-time off-gas measurement

o


Advanced Process Control

Vessel Level Control

 

 

Gravimetric Feeds

2

Up to 5

Viamass Cell Bleed/Feed Control

o

Trace Glucose Control

o

Setpoint Profile

 

 


Automation

Local Recipe Execution

 

 

Local Data Archive, Historical Trending & Batch Reporting

 

 

Secure Remote Service Access 

 

 


Safety

BioPAT® Foam single-use sensor with High Foam Alarm

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

Increase Speed to Clinic and Market 

The Biostat STR® system simplifies tech transfer and ensures consistent results during scale-up from 50 L to 2,000 L supported by BioPAT® Process Insights process scaling software, better process understanding through BioPAT® sensors, and the GMP ready Biobrain® automation platform.


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Develop Intensified Processes Faster 

Full integration of XCell ATF® Technology in the Biostat STR® hardware and software eliminates the need for additional control hardware and simplifies perfusion process development, setup, and control.  

  • Accelerate procurement and commissioning with fully integrated XCell ATF® control hardware 
  • Simplify training and operation with XCell™ control software seamlessly embedded within 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 

Transfer with Confidence


The Biostat STR® 3 enables seamless scaling from Ambr® 250 up to 2,000 L based on conserved geometry and supported by BioPAT® Process Insights software.  

  • Benefit from a conventional stirred-tank design with conserved geometry between bioreactor families from 250 mL to 2,000 L
  • Facilitate scaling with BioPAT® Process Insights a multi-parameter software tool for a fast and confident transition from PD to production
  • Ensure a smooth tech transfer to manufacturing with the GMP-compliant Biobrain® automation system

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


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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

PDF | 1.4 MB

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