App Note: Scale to 500L with ≥13% recovery increase​

Repligen, in collaboration with Forge Biologics conducted a case study where  AAV capture purification step was scaled from 1L at PD to 500L at pilot scale. The results  demonstrated an overall recovery increase of ≥13% with no increase in impurities.​

Learn How

every drop counts

Innovative valve block technology eliminates dead legs

Repligen valve blocks support consistent flow dynamics from mixing valve to column.

Traditional valves

Hose barb connections create dead legs and increase hold-up volume across the flow path.

Zero-dead leg valve block technology

Injection molding and overmolded connections  at critical junctions eliminate dead legs and decrease hold-up volume.

  EVERY DROP COUNTS

Low hold-up filter and sensor solution replaces  bubble trap

传统气泡陷阱

Up to 500 ml of hold-up volume can uncontrollably disrupt gradient, causing back mixing and dilution, harming reproducibility and recovery.

Repligen过滤器和液位传感器解决方案​

  • 使用过滤器可最大限度地减少滞留体积,有助于维持梯度控制并促进更高的回收率。​
  • 与过滤器相连的液位传感器实现空气释放的自动化
  EVERY DROP COUNTS

Over-molded connections reduce shear stress

Hose barb connections create dead legs and increase hold-up volume across the flow path.

传统技术

传统解决方案在管路连接处使用软管倒刺接头、扎带和单独的阀门,由于内径变窄,会对产品造成过多的剪切应力,且液流进入显著的死角。

Repligen技术

超模塑连接一致的内径结合注塑成型管路,加上关键连接处的阀组硬件,消除了死角,最大限度地降低了剪切应力,可保护产品的完整性。

ONE DESIGN SCALED PERFECTLY

Innovation and precision engineering at four different sizes

To remove process scale-up challenges, KRM™ Systems are part of one family built off of one design. The goal is to streamline scale-up from 1 L/h to 3600 L/h.

  • One optimized flow path design
  • Consistent hardware, including pumps
  • Identical user experience

  SINGLE-USE AND SIMPLIFIED

Precise buffer control enables maximal product recovery

Precise process control of buffer composition, optimal flow path and hardware design unlock accurate gradient control and improved recovery.

 SINGLE-USE AND SIMPLIFIED

Error-free installation in minutes with pre-assembled flow paths

ProConnex® Flow Paths, pre-assembled and specific to the KRM™ System, are intuitively designed for simple, mistake-free installation. All system sensors are pre-calibrated and assembly is done in minutes with no confusing instructions.

Watch ProConnex® Flow Path  installation on the KRM™ 20 Chromatography System.

 Compliance and Control

Software for modern GMP manufacturing​

The KRM Chromatography Systems utilize an intuitive and recipe-driven software platform to power fully automated processes. Pre-built templates and advanced configurability enable you to unlock the full potential of automation and maximize the output of each run.​

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Explore the User Interface

All operational functions in one user friendly screen increasing operator efficiency and reducing the amount of training required.​

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Discover the Recipe Editor

Your process outcome is only as good as your recipe. Whether its pre-configured templates or the flexibility to build from scratch- this recipe editor will help you succeed​.

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Running a Recipe

Running a fully automated cGMP process has never been easier. From recipe upload to completion, the software is here to make sure you stay on track.​

                                                              

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
     

合规

  • 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

层析“再设计”

Repligen is revolutionizing how modern chromatography is performed. The result? Unprecedented recovery and operational efficiencies even with the most complex modalities.

Click on the image highlights to see key elements of chromatography redesigned.

KRM™ 层析系统

Incorporating transformative Repligen innovations in hardware engineering, fluid management and process control, KRM Chromatography Systems are designed to mitigate risk of leaks and contamination and enable an efficient, user-friendly batch change.

Click on the tabs to explore features of the different  KRM Chromatography Systems and Flow Paths.

KRM™ 10 Chromatography System

1 – 180 L/h     |     1/4“ ID

Click on the links to explore different features.

KRM™ 20 Chromatography System

6 – 900 L/h      |      1/2“ ID

Click on the links to explore different features.

KRM™ 30 Chromatography System

25 - 2000 L/h      |      3/4“ ID

Click on the links to explore different features.

KRM™ 40 Chromatography System

50 - 3600 L/h      |      1“ ID

Click on the links to explore different features.

KRM™ Flow Path

Click on the links to explore components of the Flow Path.

1. Receive 4 gamma irradiated flow path sub-assemblies.

2. Assemble and install the flow path 

  • 预校准的传感器​
  • 3 个无菌/倒刺连接 ​

3. Perform chromatogrpahy on the KRM System

解决方案
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Smooth Ride

No more speed bumps, sudden turns and dead-ends along the flow path. Give your gradient the upgraded ride it deserves and recover more product.

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设计正确

Questionable design prevents you from getting the job done.  Experience higher recovery and faster batch changes with simple and expertly crafted chromatography flow paths and hardware.

Manufacturing Centers of Excellence

Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands,  Germany and Estonia.

地点

Expert Project Management

客户至上。

Repligen DNA 为您提供支持。我们的目标是提供卓越的客户体验,并为所有 Repligen 产品和服务高效成功的采用及实施提供支持。

  • Field Application Support
  • 客户服务
  • 现场服务工程师

还有问题吗?

系统规格

KRM 10KRM 20KRM 30KRM 40
流速1 - 180 L/H6 - 900 L/H25 - 2000 L/H50 - 3600 L/H
层析柱尺寸8 - 25 cm ID20 - 45 cm ID45 - 80 cm ID60 - 80 cm ID
泵类型2 个 Quattroflow™ 泵2 个 Quattroflow™ 泵2 个 Quattroflow™ 泵2 个 Quattroflow™ 泵
传感器2 flow meters​ 4 pressure sensors​ Pre-and post-column pH/Conductivity​ Dual wavelength 254/280 or 280/300 UV 2 flow meters​ 4 pressure sensors​ Pre-and post-column pH/Conductivity​ Dual wavelength 254/280 or 280/300 UV 2 flow meters​ 4 pressure sensors​ Pre-and post-column pH/Conductivity​ Dual wavelength 254/280 or 280/300 UV 2 flow meters​ 4 pressure sensors​ Pre-and post-column pH/Conductivity​ Dual wavelength 254/280 or 280/300 UV
软件AB PLC和WonderwareAB PLC和WonderwareAB PLC和WonderwareAB PLC和Wonderware
多种流路针对每套系统专门构建的流路,实可现最佳的工艺效率 针对每套系统专门构建的流路,实可现最佳的工艺效率 针对每套系统专门构建的流路,实可现最佳的工艺效率 针对每套系统专门构建的流路,实可现最佳的工艺效率
Tubing ID 1/4 inch 1/2 inch 3/4 inch 1 inch