GE Healthcare Membrane chromatography using ReadyToProcess™ Adsorber Selection guide ReadyToProcess Adsorber is a range of chromatography membranes primarily used for polishing of monoclonal antibodies (MAbs) and other biomolecules. For convenient and reliable scale-up, the ReadyToProcess Adsorber product line is available from 96-well screening formats for highthroughput process development (HTPD), all the way to sizes for large-scale production. This document provides an overview of which chromatography system is suitable for operating a certain ReadyToProcess Adsorber capsule. Recommended systems Other systems and pumps System choice considerations ReadyToProcess Adsorber is primarily recommended to be operated by ÄKTA™ chromatography systems to enable scalability from process design to large-scale manufacturing. The ÄKTA platform provides process control and data logging for batch documentation. It is also fully scalable and covers all major chromatographic and cross flow filtration techniques. Inline Conditioning systems ReadyToProcess Adsorber membrane capsules can be operated by Inline Conditioning systems—automated liquid handling systems built for large-scale biopharmaceutical manufacturing. Inline Conditioning systems act as a buffer preparation unit and enable automatic inline buffer formulation using concentrated stock solutions. For increased flexibility, the Inline Conditioning system can have integrated chromatography functionality. Flow capability vs required flow rate When selecting a system for running membrane chromatography, the first aspect to consider is the flow capability of the system versus the required flow rate for running the membrane. Recommended flow rates are 30 and 5 membrane volumes (MV)/min for ReadyToProcess Adsorber membranes with 4 and 8 mm bed height, respectively. However, the chromatographic performance of membranes is often maintained even at lower flow rates and a system with a lower flow rate than the recommended can therefore be used. ÄKTA lab-scale systems ÄKTA start, ÄKTA pure, and ÄKTA avant systems are recommended for operating small-scale ReadyToProcess Adsorber membrane capsules. ÄKTA pilot and production systems ÄKTA ready, ÄKTApilot™, and ÄKTAprocess™ systems are recommended for manufacturing purposes. They offer high process control, extensive batch documentation, and more. Peristaltic pumps ReadyToProcess Adsorber membrane capsules can also be operated by simple peristaltic pumps, like the Watson-Marlow™ 520 series. However, peristaltic pumps do not provide the same process control and data logging functionality as the ÄKTA systems. Possible flow rates span between 1 and 30 MV/min for membranes with 4 mm bed height. For membranes with 8 mm bed height flow rates between 1 and 5 MV/min can be used. The possibility to run the membranes at lower flow rates greatly simplifies the system selection. Dilution effect considerations Dilution effects should always be considered when selecting a system to run ReadyToProcess Adsorber membranes. The dilution effect is usually minor for flow-through (FT) applications, but more significant for for bind-elute (B/E) operation, especially when preparing scale-up. Chromatography membranes can be run at high flow rates and large systems can therefore be used to run a wide variety of membrane sizes. A larger system and void volume will, however, result in an increased dilution effect. For further assistance, please contact a GE Healthcare chromatography application specialist. Bed height (mm) Adsorber Q Jumbo 8 mm Adsorber S Jumbo 8 mm Adsorber Phen Jumbo 8 mm Adsorber Q 1.2 8 mm Adsorber S 1.2 8 mm Adsorber Phen 1.2 L 8 mm Adsorber Q 800 8 mm Adsorber S 800 8 mm Adsorber Phen 800 8 mm Adsorber Q 400 8 mm Adsorber S 400 8 mm Adsorber Phen 400 8 mm Adsorber Q 150 8 mm Adsorber S 150 8 mm Adsorber Phen 150 8 mm Bind-elute 4 (recommended flow rate 30 MV/min) 8 (recommended flow rate 5 MV/min) 0.08 mL 1 mL 75 mL 200 mL 400 mL 600 mL 2.5 L 0.08 mL 3 mL 150 mL 400 mL 800 mL 1.2 L 5L Recommended flow rate (mL/min) 2.4 30 2250 6000 12 000 18 000 60 000 2.4 15 750 2000 4000 6000 25 000 Recommended flow rate (L/h) 0.14 1.8 135 360 720 1080 3600 0.14 0.9 45 120 240 360 1500 Volume Maximum pressure (bar*) 4 System Flow rate Detectors ÄKTA start 0.5–5 mL/min Flow, pressure, UV, conductivity ÄKTA pure 25 0.001–25 mL/min Flow, pressure, UV, conductivity, pH ÄKTA pure 150 0.01–150 mL/min Flow, pressure, UV, conductivity, pH ÄKTA avant 25 0.001–25 mL/min Flow, pressure, UV, conductivity, pH ÄKTA avant 150 0.01–150 mL/min Flow, pressure, UV, conductivity, pH ÄKTApilot 4–800 mL/min Flow, pressure, UV, conductivity, pH ÄKTA ready, with Low Flow Kit 3–175 L/h Flow, pressure, UV, conductivity, pH ÄKTA ready, with High Flow Kit 7.5–510 L/h Flow, pressure, UV, conductivity, pH 4–180 L/h Flow, pressure, UV, conductivity, pH electrode (optional) ÄKTAprocess, 10 mm polypropylene or 1/2 in stainless steel Adsorber Q Nano 8 mm Adsorber S Nano 8 mm Adsorber Phen Nano 8 mm Flow-through Recommended application ÄKTAprocess, 6 mm polypropylene or 3/8 in stainless steel Adsorber Phen Pico 4 mm Adsorber Q 2.5 L 4 mm Adsorber Q 600 4 mm Adsorber S 600 4 mm Adsorber Q 400 4 mm Adsorber S 400 4 mm Adsorber Q 200 4 mm Adsorber S 200 4 mm Adsorber Q 75 4 mm Adsorber S 75 4 mm Adsorber Q Nano 4 mm Adsorber S Nano 4 mm Adsorber Q Pico 4 mm Adsorber S Pico 4 mm ReadyToProcess membrane 15–600 L/h Flow, pressure, UV, conductivity, pH electrode (optional) ÄKTAprocess, 1 in polypropylene or stainless steel 45–1800 L/h Flow, pressure, UV, conductivity, pH electrode (optional) Inline Conditioning, 6 mm polypropylene or 3/8 in stainless steel 4–180 L/h Flow, pressure, UV, conductivity, pH Inline Conditioning, 10 mm polypropylene or 1/2 in stainless steel 15–600 L/h Flow, pressure, UV, conductivity, pH Inline Conditioning, 1 in polypropylene or stainless steel 45–1800 L/h Flow, pressure, UV, conductivity, pH Inline Conditioning, 1 1/2 in stainless steel 500–5000 L/h Flow, pressure, UV, conductivity, pH Inline Conditioning, 2 in stainless steel 1000–10 000 L/h Flow, pressure, UV, conductivity, pH Pressure, conductivity, temperature Watson-Marlow 520 series, pumpscil 3/8 in, 1.6–3500 mL/min with ReadyCircuit assemblies Pressure, conductivity, temperature Watson-Marlow 620 series, pumpscil 3/8 in, 0.003–7.2 L/min with ReadyCircuit assemblies Pressure, conductivity, temperature Watson-Marlow 620 series, pumpscil 1/2 in, 0.004–11 L/min with ReadyCircuit assemblies Pressure, conductivity, temperature Watson-Marlow 720 series, pumpscil 1/2 in, up to 760 L/h with ReadyCircuit assemblies, 2 bar Pressure, conductivity, temperature Watson-Marlow 720 series, pumpscil 3/4 in, up to 1390 L/h with ReadyCircuit assemblies, 1 bar Pressure, conductivity, temperature www.gelifesciences.com/readytoprocess Connector on membrane capsule: Watson-Marlow 520 series, pumpscil 1/4 in, 0.7–1500 mL/min with ReadyCircuit™ assemblies * 1 bar = 14.5 psi = 0.1 MPa Luer female connector 3/4 in sanitary clamp or hose barb 3/4 in sanitary clamp 1 1/2 in sanitary clamp GE and GE monogram are trademarks of General Electric Company. ÄKTA, ÄKTApilot, ÄKTAprocess, ReadyCircuit, and ReadyToProcess are trademarks of General Electric Company or one of its subsidiaries. Watson-Marlow is a trademark of Watson-Marlow Ltd. All other third party trademarks are the property of their respective owner. © 2015 General Electric Company—All rights reserved. First published Jun. 2015 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information. GE Healthcare Bio-Sciences AB, Björkgatan 30, SE-751 84 Uppsala, Sweden. 29156202 AA 06/2015
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