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KRM® Chromatography Systems
KRM Chromatography Systems are an automated single-use chromatography platform for both isocratic and gradient chromatographic batch purification processes. Designed to maximize protein purification and recovery of biomolecules, these systems reduce hold-up volume, eliminate dead legs, and enable consistent performance from process development through pilot and commercial manufacturing.
product features
Every drop counts
Maximize recovery and achieve precise linear gradient control with innovative technologies designed to eliminate dead legs, minimize hold-up, and enhance process control
Scalable Solution
Effortless scale-up with consistent hardware, controls, flow path design, and user experience across all systems
Unparalleled Software Flexibility
Leverage end-to-end automation with flexible recipe editing, secure data storage, and seamless connectivity
Purification Solutions for Today's Most Demanding Biologics
From viral vectors and recombinant proteins to monoclonal antibodies and emerging modalities, KRM Chromatography Systems are designed to help maximize recovery while supporting efficient scale-up from development through manufacturing. Applications include:
Modalities
- AAV and Lentiviral vector purification
- Recombinant protein purification
- Monoclonal antibody purification
- Antibody drug conjugate purification
Purification Workflows
- Capture chromatography
- Intermediate purification
- Polishing chromatography
- Gradient and isocratic chromatography
Manufacturing Lifecycle
- Process development
- Process characterization
- Technology transfer
- Pilot manufacturing
- Commercial manufacturing
Minimize Dead Legs, Boost Product Recovery
Traditional chromatography systems rely on hose barb connections and discrete components that can create dead legs throughout the flow path. These stagnant areas increase hold-up volume, contribute to product loss, and can impact process consistency.
KRM Chromatography Systems utilize injection-molded manifolds and innovative valve block technology to create a streamlined flow path with zero-dead-leg connections at critical junctions. By reducing unnecessary hold-up volume and maintaining consistent flow dynamics from valve to column, KRM helps maximize product recovery while supporting reproducible process performance.
Every milliliter saved from hold-up volume helps maximize yield, efficiency, and the value of every batch.
Preserve Gradient Integrity, Eliminate Bubble Traps
Bubble management is critical to chromatography performance. Air can disrupt gradients, affect sensor accuracy, and potentially compromise column operation. Traditional bubble traps address these challenges but often introduce significant hold-up volume, unwanted mixing effects, and additional opportunities for product retention. The KRM chromatography system takes a different approach. An integrated assembly combines filtration, level sensing, and automated venting into a streamlined, low hold-up volume design. By effectively removing air while minimizing retained volume, the system helps preserve gradient integrity, protect the chromatography column, and keep more product moving through the process.
Traditional bubble trap
Up to 500 ml of hold-up volume can uncontrollably disrupt gradient, causing back mixing and dilution, harming reproducibility and recovery.
Repligen filter and level sensor solution
- Use of a filter minimizes hold up volume helps maintain gradient control and promotes higher recovery
- By combining a level sensor with the filtration assembly, the system automatically detects and removes air through an automated vent valve, minimizing operator intervention
Scalable Single-Use Chromatography Platform
As purification demands grow, hardware or process changes can introduce complexity, risk, and variability. KRM Chromatography Systems are built around a common platform architecture that maintains the same core design principles across four system sizes, helping teams scale with confidence from development through manufacturing.
The consistent system design supports a familiar operating experience while preserving the recovery-focused features including zero-dead-leg valve blocks, low hold-up volume flow paths, and pre-assembled single-use flow kits.
Benefits
- Common platform architecture across four system sizes
- Consistent hardware, software, and process design from development to manufacturing
- Simplified scale-up and technology transfer
Case Study
Proven Linear Scalability for AAV Manufacturing
In collaboration with Forge Biologics, a leading gene therapy CDMO, the KRM 10 Chromatography System successfully scaled an AAV9 capture chromatography process from a 5 mL bench-scale column to a 515 mL manufacturing-scale column while maintaining consistent process performance and product quality. The study demonstrated linear scale-up using the same process parameters, column bed heights, and buffer conditions across scales, resulting in a 13% increase in AAV recovery at manufacturing scale compared to bench-scale operation.
Key Results
- Demonstrated linear scalability from 1 L to 167 L load volumes.
- Manufacturing-scale runs achieved a 13% increase in AAV recovery compared to bench-scale runs
- Successfully scaled 100X from 5 mL to 515 mL OPUS® columns using the same process conditions
Download the Application Note to see how Forge Biologics achieved scalable, reproducible AAV9 purification with the KRM 10 Chromatography System.
Bring Real-Time Process Intelligence to Chromatography with KRM RPM® System
Data is most valuable when it can drive action. KRM RPM® combines the KRM Chromatography System with the integrated PATsmart™ FlowVPX® in-line spectrophotometer, enabling continuous concentration measurement directly within the process stream. The result is real-time visibility into process conditions without relying on periodic sampling or offline analysis.
By transforming concentration data into actionable process insight, KRM RPM® system helps operators gain a deeper understanding of chromatography performance, monitor critical process conditions as they occur, and move toward more automated, data-driven process execution. By leveraging real-time analytical feedback, teams can reduce manual intervention, improve process consistency, support higher yields, and establish a foundation for PAT-driven control and Pharma 4.0 manufacturing strategies.
Standardize Downstream Operations with KlariFi™ Software
Reliable protein purification and successful scale-up require more than consistent hardware. KlariFi™ Software provides a common control environment across all KRM chromatography systems, enabling recipe-based operation, process monitoring, and fully automated execution from development through GMP manufacturing.
Designed to support consistent workflows and reproducible chromatography performance, KlariFi helps simplify technology transfer, reduce operator variability, and provide confidence at every scale.
Software/Recipe Editor
- Intuitive point and click interface
- Extensive pre-configured recipe templates and flexibility to create your own
- Sequential flow charts for recipe visualization
- Windows-integrated access control
- Recipes directly transferable between systems
- Recipes can be paused and adjusted during run while maintaining batch integrity
Control hardware
- Allen Bradley industrial PLC
- HMI with a touch-screen and glass keyboard
Secured connectivity
- Ethernet/IP and OPC/OPCUA
- to external Scada/DCS/MES systems
Compliance
- GAMP5 and 21 CFR Part 11
- SA88 standards
- UL/CE
Reporting and trending
- Secure batch reports
- Customizable data trending
- SQL data base
- Historized tags and calculated values
Alarms and events
- Customizable process alarms
- Secured alarm and event logs
Did you know?
KlariFi™ Software brings clarity to downstream processing with a unified automation platform across multiple unit operations. Use KlariFi™ to run purification workflows on KRM Chromatography Systems as well as ultrafiltration and diafiltration (UF/DF) processes on KrosFlo® RS TFF Systems, helping standardize operation, training, and process execution across downstream operations.
Error-Free Installation in Minutes with ProConnex® Flow Paths
ProConnex® Flow Paths are pre-assembled and purpose-built for KRM Chromatography Systems, eliminating the complexity of manual assembly and reducing the opportunity for installation errors. With pre-calibrated sensors and an intuitive flow path design, operators can move from setup to operation in minutes with confidence.
Why it matters?
Faster setup, reduced operator variability, and more time focused on the process—not assembling the system.
Ready to See What KRM Can Do for Your Process?
Whether you're evaluating chromatography platforms, planning to scale-up, or exploring new approaches to improve recovery and process control, our experts can help you determine if KRM Chromatography Systems are the right fit for your application.
KRM Chromatography System Specifications
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|---|---|---|---|---|
| System | KRM 10 | KRM 20 | KRM 30 | KRM 40 |
| Flow rate range (L/h) | 1 - 180 | 6 - 900 | 25 - 2000 | 50 - 3600 |
| Column ID size (cm) | 5 - 25cm ID | 20 - 45cm ID | 45 - 120cm ID | 60 - 120*cm ID |
| Pump type | 2 diaphragm pumps | 2 diaphragm pumps | 2 diaphragm pumps | 2 diaphragm pumps |
| pH range | 3 - 10 | 3 - 10 | 3 - 10 | 3 - 10 |
| Conductivity (mS/cm) | 0 - 150 | 0 - 150 | 0 - 150 | 0 - 150 |
| Tubing ID (in) | 1/4 | 1/2 | 3/4 | 1 |
| Hold-up volume (L) (with filter and trap) | <0.45 | <1.22 | <4.3 | <7.7 |
*Depending on process requirements, system is capable of utilizing 200 cm ID column
Single-use chromatography systems can help reduce cleaning requirements, simplify changeovers, minimize contamination risk, and accelerate deployment. Pre-assembled flow paths can also reduce setup complexity and support more consistent operation across manufacturing campaigns.
Gradient control directly impacts chromatography performance by influencing separation efficiency, product purity, and process reproducibility. Inaccurate gradients can lead to inconsistent elution profiles, reduced recovery, and variability between runs. In linear gradient studies, KRM Chromatography Systems demonstrated gradient accuracy within 1–2%, highlighting the platform's ability to deliver consistent and predictable gradient performance. This level of control helps support reproducible separations, reliable scale-up, and confidence in chromatography process execution.
KRM Chromatography Systems support a broad range of downstream purification applications across process development, pilot, and commercial manufacturing. Common applications include viral vector purification, recombinant proteins, monoclonal antibodies, capture chromatography, and polishing chromatography.
KRM Chromatography Systems are compatible with a broad range of chromatography columns used in process development, pilot, and manufacturing environments, including OPUS® pre-packed chromatography columns. Column compatibility depends on system configuration, column dimensions, and process requirements.
Yes. KRM Chromatography Systems can support integration into facility-wide automation architectures, including distributed control systems (DCS) used in GMP manufacturing environments. This enables organizations to incorporate chromatography operations into broader digital manufacturing strategies, while maintaining centralized process visibility and control.
KRM RPM® (Real-time process monitoring) combines the KRM Chromatography System with the integrated PATsmart™ FlowVPX® in-line spectrophotometer to provide continuous concentration measurement directly within the process stream.
By delivering real-time concentration data throughout purification, KRM RPM enables deeper process understanding, improved visibility into critical process conditions, and a foundation for PAT-driven process control strategies. The result is more automated control based on live process data.
PATsmart™ FlowVPX® provides continuous in-line concentration measurement without interrupting the process. By eliminating the need for periodic sampling and offline testing, FlowVPX helps operators gain real-time insight into process performance and supports more data-driven process control.
Related Products
OPUS® Pre-packed Chromatography Columns
Accelerate process development and scale-up with consistent performance, reduced operational complexity, and faster deployment from lab to commercial production.
Affinity Resins
The world's leading manufacturer of affinity ligands now makes best-in-class affinity purification resins for antibodies, proteins, viral vectors, IgGs, Fc fragments, and Fc fragments.
Fluid Management
Own your process with ProConnex® — streamlined fluid management solutions that reduces risk, improves consistency, and accelerates your path to production.
Process Analytics
Our process analytics solutions, featuring Variable Pathlength Spectroscopy for at-line and in-line concentration monitoring systems, ensure that products meet required Process Analytical Technology (PAT) standards. These tools provide critical data for optimizing bioprocesses and ensuring compliance with regulatory requirements.
KlariFi™ Software
KlariFi™ is an intuitive, end-to-end recipe-driven automation software for downstream bioprocessing professionals using Repligen systems for filtration or chromatography.
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