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

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​
  • A level sensor coupled with the filter enables the automation of  air release
  EVERY DROP COUNTS

Over-molded connections reduce shear stress

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

Traditional technology

Traditional solutions utilize  hose barbs, zip ties and individual valves at tubing junctions causing excess shear stress to the product as inner diameter narrows and flow dips into significant dead legs.

Repligen Technology

The consistent ID of overmolded connections coupled with injection molded tubing and valve block hardware at critical junctions eliminate dead-legs, minimize shear stress and protect product integrity.

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
     

コンプライアンス

  • 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

Chromatography Redesigned

Repligenは、現代のクロマトグラフィーの手法に革命をもたらしています。その結果、最も複雑なモダリティでも、前例のない回収率と運用効率を実現しています。

画像のハイライトをクリックすると、設計を新たにしたクロマトグラフィーの主要要素が表示されます。

KRM™ Chromatography Systems

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 

  • Pre-calibrated sensors​
  • 3 connections aseptic/hosebarb​

3. Perform chromatogrpahy on the KRM System

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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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Designed right

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は、ISO 9001品質管理システムに基づいて、バイオ医薬品業界向けの製品を開発・製造しています。高品質で安定した、堅牢な製品をタイムリーに提供し、お客様の事業継続性を保証することを重視しています。

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

Locations

Expert Project Management

お客様第一。

サポートは、Repligenという企業の遺伝子に組み込まれています。弊社の目標は、卓越した顧客体験を提供すること、そしてRepligenの製品やサービスの適用や導入を効率よく成功に導くためにサポートすることです。

  • Field Application Support
  • カスタマーサービス
  • フィールドサービスエンジニア

お問い合わせ

システム仕様

KRM 10KRM 20KRM 30KRM 40
流量1 - 180 L/h6 - 900 L/h25 - 2000 L/h50 - 3600 L/h
Column size8 - 25 cm ID20 - 45 cm ID45 - 80 cm ID60 - 80 cm ID
Pump type2 Quattroflow™ pumps2 Quattroflow™ pumps2 Quattroflow™ pumps2 Quattroflow™ pumps
センサー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
ソフトウェアAB PLC and WonderwareAB PLC and WonderwareAB PLC and WonderwareAB PLC and Wonderware
Multiple flow pathsOne built for purpose flowpath on each system for optimal process efficiency One built for purpose flowpath on each system for optimal process efficiency One built for purpose flowpath on each system for optimal process efficiency One built for purpose flowpath on each system for optimal process efficiency
Tubing ID 1/4 inch 1/2 inch 3/4 inch 1 inch