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Sartobind® - 10 Pages

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Membrane Adsorber capsules, 4 mm bed height turning science into solutions

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Sartobind Capsules for Economic Production of Therapeutic Proteins High speed polishing Sartobind SingleSep® capsules are designed to remove charged contaminants from therapeutic proteins at accelerated flow rates by ion exchange membrane chromatography. The high throughput is a direct result of negligible mass transfer effects and is made possible by the >3 µm macroporous membrane with 4 mm bed height. Approved technology In 2001 Campath®* received FDA approval. This monoclonal antibody is polished by application of Sartobind ion exchange Q modules in flow through mode (DNA|...

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Application Area In a generic downstream process for the production of a monoclonal antibody, the main capturing steps are followed by the polishing step(s). The later the anion exchanger is applied in the process, the less contaminants have to be removed. Sartobind usage in monoclonal antibody production: Cell removal |Clarification Affinity Chromatography Cation Exchange Chromatography Anion Exchange Adsorber Polishing Step (flowthrough): Removal of DNA, HCP, Endotoxins Virus Clearance Ultra-|Diafiltration The positively + charged ligand of the _ Q adsorbers binds negatively charged _...

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Virus clearance This study5 also demonstrates excellent virus log reduction values with Sartobind Q. This enables membrane adsorber technology to replace a Q column without compromising critical viral clearance capabilities. Minute Virus of Mice (MVM) 50 ml virus spiked protein sample 500 ml virus spiked protein| buffer solution Fig. 5: No size exclusion effects for viruses Murine Leukemia Virus (MuLV) 5 . Zhang (Abgenix Inc.) et al, Viral Clearance Feasibility Study with Sartobind Q Membrane Adsorber for Human R Antibody Purification, BioProduction 2004, Munich Germany 26–27 October 2004....

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Technical data Fig. 7: Sartobind pico 0.08 ml for process development and virus studies Fig. 8: Sartobind Q SingleSep nano 1 ml Base material Membrane thickness Pore size (nominal Capsule materials Outer cage, inner core, end caps, capsule housing, Stabilized reinforced cellulose strong anion Q (quaternary ammonium) strong cation S (sulfonic acid) R-CH2-S03~ anion exchanger (primary amine) -NH2 * only with 10", 20", 30" and mega capsules 121 °C for 30 minutes for one cycle only Maximum operating pressure Connector Luer Lock Luer Lock Sanitary 3A" Sanitary 1V2" Sanitary IV2" Sanitary V2"...

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Ordering Information Order no. Chemistry Description Quantity Bed Bed Nominal Frontal Protein Recom- Approx. adapter inlet volume height membrane surface* binding mended Capsule and outlet [ml] [mm] area area capacity** flow rate weight Sartobind pico Sartobind nano Sartobind mini Sartobind mega * Frontal surface area = average cylinder surface ** Typical dynamic binding capacity at 10% breakthrough was measured with BSA for Q | PA and lysozyme for S chemistry. For Sartobind STIC PA 150 mM NaCI was added to the buffer.

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Sartobind STIC capsules Order no. Chemistry Description Quantity Bed Bed Nominal Frontal Protein Recom- Approx. adapter inlet volume height membrane surface* binding mended Capsule and outlet [ml] [mm] area area capacity** flow rate weight Sartobind pico Sartobind nano Sartobind mega Sartobind pico Sartobind nano Sartobind mini * Frontal surface area = average cylinder surface "Typical dynamic binding capacity at 10% breakthrough was measured with BSA for Q | PA and lysozyme for S chemistry. For Sartobind STIC PA 150 mM NaCI was added to the buffer.

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5ZGI--0001 Stainless steel holder for one 10, 20 or 30 inch capsule, 3 legs 5ZGLG-0004 Stainless steel holder for three 10, 20 or 30 inch capsules, 3 legs 5ZALB-0002 Stainless steel distribution adapter for three 10, 20 or 30 inch capsules 9ZAIAM0001 Stainless steel legs for mega, 3 items Adapter Sanitary 25 mm 1–3“ to UNF10–32 to connect mini to LC systems, 2 items Adapter Luer male to UNF – 10–32 female, PEEK, 1 item Fig. 9: Adapter to connect mini with sanitary connection to liquid chromatography systems Fig. 10: A Sartobind mega capsule on stainless ste

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Sales and Service Contacts For further contacts, visit www.sartorius-stedim.com Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Italy Sartorius Stedim Italy S.p.A. Via dell’Antella, 76/A 50012 Antella-Bagno a Ripoli (FI) USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY 11716 Sartorius Stedim Systems GmbH Robert-Bosch-Strasse 5 – 7 34302 Guxhagen Netherlands Sartorius Stedim Netherlands B.V. Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone +49.5665.407.0 Fax +49.5665.407.2200 France...

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