Dynamic Process Oversight

We’ve seamlessly integrated the CTech™ FlowVPX® in-line spectrophotometer into our KrosFlo® FS-15 TFF System, enhancing our RPM™ Series that supports a PAT-enabled approach to manage processes in real time. By incorporating the FlowVPX instrument into UF/DF operations, we ensure continuous tracking of target concentrations, enabling precise feedback control.
The FS-15 RPM System autonomously manages the UF/DF process using real-time data. This removes the dependency on concentration factors, mass inputs or manual, off-line UV-Vis analysis. With the combined capabilities of the FS-15 Automated TFF System and insights from the CTech FlowVPX System, you achieve unparalleled control over your process using direct concentration measurement.

  • Enhance process control: the PAT-controlled TFF system enables precise manipulation and monitoring of process parameters, ensuring consistent and reproducible outcomes. 
  • Boost process efficiency: automated inline concentration monitoring allows for real-time adjustments to the UF/DF process, minimizing cycle times and enhancing throughput. 
  • Reduce process risk: by continuously tracking concentration measurement, the automated system prevents deviations from desired process conditions, thereby reducing the risk of product degradation or non-compliance with quality standards. 

The RPM™ Difference

Introducing our RPM™ (Real-time Process Management) Series of TFF Systems, designed to transform process control in bioprocessing. By seamlessly integrating the CTech™ FlowVPX® in-line spectrophotometer into our KrosFlo® TFF Systems, the RPM™ Series provides unparalleled real-time insights and control over UF/DF processes. This innovative approach empowers users to optimize efficiency, quality, and productivity in biomanufacturing. Discover how our RPM™ Series sets a new standard for real-time process control.

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Real-time Concentration Insights

 

CTech™ FlowVPX® System

With capabilities for real-time decision-making, the FlowVPX® System ensures improved product uniformity and quality. Employing Variable Pathlength Spectroscopy, it optimizes process efficiency, eliminating the need for labor-intensive dilution and background correction steps, conserving critical time and resources. Through in-line measurements providing immediate feedback, the UF/DF process can proceed uninterrupted, avoiding errors associated with off-line analysis. Consequently, your UF/DF process operates efficiently, ensuring superior quality outcomes.

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KrosFlo® RPM™ Software
The integrated software merges the FS-15 automation with real-time insights from the FlowVPX System, delivering the data and control you need.

  • Automation control of TFF based on in-line concentration measurements.
  • Real-time overview at each stage of the filtration process.
  • Automatic graphing of data and trends for critical inputs and outputs.
  • Versatile plug-and-play technology catering to custom requirements.
     

Enhanced Insights for Improved Outcomes
 

The FS-15 RPM System directly informs and controls the process, guaranteeing desired outcomes. By utilizing this in-line concentration data, you can evaluate measurements without prior calculations or overcompensating for variability. Providing crucial process insights allows for a deeper understanding of your process—reducing cycling time and minimizing batch risk. Focus on achieving the end goal by eliminating common sources of error seen with concentration factor (intermediate characteristic). Using in-line concentration data as the key control factor for the UF/DF run enables the process to achieve target final concentration regardless of starting volume, crossflow rate, TMP, or retentate hold-up volume

One Analytical Platform for Maximum Alignment

Variable Pathlength Technology (VPT) promotes alignment across different steps and functions. To complement the FlowVPX System’s in-line analysis and all RPM™ Systems, the CTech™ SoloVPE® System offers the same level of accuracy using at-line or off-line measurements, ensuring reliable quality control at additional stages of the process.

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Application Services

Your success is our success

Repligen is committed to our customers’ success. We’ve designed our CTech™ Service offerings to supplement our standard support options and provide you with increased access to our highly knowledgeable and experienced professionals. We offer implementation, development, and educational guidance to maximize the benefits of your variable pathlength solutions and the Slope Spectroscopy® technique.

Application Services

  • 21 CFR Part 11 Guidance
  • Annex 11 Guidance
  • Validation Support
  • Qualification Service
  • Method Transfer Service

Development

  • Method Design & Development
  • Comparability
  • On-Site Support
  • Custom Standards
  • Process Auditing

 

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Education

  • SOP Document Review
  • Advanced Slope Spectroscopy Training
  • Data Analysis
  • Maintenance & Troubleshooting