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GE17-5438-02

MabSelect SuRe

Cytiva, 17-5438-02, pack of 200 mL

  •  NACRES NA.56

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Properties

Related Categories Antibodies, Antibody Purification and Characterization, MabSelect mAb Purification, Protein A, G and L Resins, Supplementary Products More...
shelf life   Please be aware this product may be shipped 90 days before the expiration date. For more information on the batch specific expiration date, please contact technical service.
packaging   pack of 200 mL
mfr. no.   Cytiva, 17-5438-02
matrix   highly cross-linked agarose
avg. part. size   85 μm (d₅₀v is the median particle size of the cumulative volume distribution)
cleaning in place   2 - 13.7 (pH below 3 is sometimes required to elute strongly bound IgG species. However, protein ligands may hydrolyze at very low pH.)
working range   3 - 12 (pH below 3 is sometimes required to elute strongly bound IgG species. However, protein ligands may hydrolyze at very low pH.)
capacity   ≥30 mg binding capacity (humanlgG/ml at 2.4 min residence time)(Determined at 10% breakthrough by frontal analysis at a mobile phase velocity of 500 cm/h in a column with a bed height of 20 cm.)
suitability   suitable for bioprocess medium
storage temp.   2-8°C

Description

General description

MabSelect SuRe is a protein A affinity medium for capturing MAbs at process scale. MabSelect SuRe has an alkali-tolerant rProtein A ligand that allows the use of rigorous and cost-effective CIP and sanitization protocols based on 0.1 to 0.5 M NaOH. Further, the ligand is protease stable leading to lower ligand leakage.

MabSelect SuRe is a member of the MabSelect family of affinity chromatography media for the capture of monoclonal antibodies (MAbs) at process scale. MabSelect SuRe shares features and benefits of MabSelect such as a rigid, high-flow agarose matrix that ensures excellent pressure/flow properties, low non-specific binding that leads to low impurity levels in the eluate pool, and an oriented ligand coupling for optimal binding capacity. In addition, MabSelect SuRe features an alkali-tolerant rProtein A ligand. This ligand provides greater stability than conventional protein A-based media in the alkaline conditions used in cleaning-in-place (CIP) and sanitization protocols. The enhanced alkali stability of MabSelect SuRe improves process economy and product quality; cleaning can be performed with cost-effective reagents such as sodium hydroxide eliminating the need for expensive and hazardous cleaning agents such as Gua-HCl.

The novel ligand construct of MabSelect SuRe has been proven to have an increased stability towards proteases. Therefore, the level of leakage of the MabSelect SuRe ligand during elution is low. MabSelect SuRe has been demonstrated to give generic elution conditions for different monoclonal antibodies, which is an advantage when designing generic purification platform processes. This feature is also correlated to the construction of the MabSelect SuRe ligand.

MabSelect SuRe is available in a range of different bulk pack sizes and convenient pre-packed formats for easy scale-up and process development. As member of the BioProcess media range, MabSelect SuRe meets industrial demands with security of supply and comprehensive technical and regulatory support.

Features and Benefits

• Novel, alkali-tolerant rProtein A ligand withstands rigorous CIP and sanitization procedures with 0.1 to 0.5 M NaOH.
• Reduces the risk of product contamination and carryover
• Improves product quality and reduces overall costs
• Novel ligand design gives enhanced protease resistance resulting in lower ligand leakage
• Generic elution profile for different monoclonal antibodies enables platform approach to purification
• Used in the commercial manufacture of monoclonal antibodies
• High-flow agarose matrix allows the processing of large feed volumes

Analysis Note

To view the Certificate of Analysis for this product, please visit www.gelifesciences.com.

Legal Information

Free MabSelect SuRe Ligand
"MabSelect SuRe Ligand Restricted License" and "Cys-rProtein A Ligand Restricted License" are protected by the following patents and equivalent patents and patent applications in other countries: US 6,399,750 and EP 1123389. A free, non-transferable limited license to use this product for internal analytical purposes only accompanies the purchase of the product from a GE Healthcare company and its licensed distributors. Any other use will require a separate license from a GE Healthcare company.

MabSelect is a trademark of Cytiva

SuRe is a trademark of Cytiva

Safety & Documentation

Safety Information

RIDADR 
NONH for all modes of transport

Documents

Certificate of Analysis (COA)

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Protocols & Articles

Articles

Antibody Basics

Immunoglobulins (Igs) are produced by B lymphocytes and secreted into plasma. The Ig molecule in monomeric form is a glycoprotein with a molecular weight of approximately 150 kDa that is shaped more ...
Keywords: Affinity chromatography, Centrifugation, Chromatography, Digestions, Direct immunofluorescence, Gene expression, High performance liquid chromatography, Immunofluorescence, Ion Exchange, Microscopy, Precipitation, Purification, Rheumatology, Scanning electron microscopy

Column Packing and Preparation for Affinity Chromatography of Antibodies

Appendix 5, Extracted from Affinity Chromatography Vol. 1: Antibodies, GE Healthcare, 2016  
Keywords: Affinity chromatography, Antimicrobials, Chromatography, Detergents, Gene expression, Separation, Solvents

Protocols

A Flexible Antibody Purification Process Based on ReadyToProcess Products with Capto Adhere

In this study, a series of experiments was undertaken to determine whether shorter time-to-clinic and cost savings could be achieved using ReadyToProcess products. The work involved scaling up a two-...
Keywords: Chromatography, Fermentation, Filtration, Ligands, Purification, Reductions

Bind/Elute vs Flowthrough Mode in Multimodal Chromatography

In multimodal chromatography, the choice between bind/elute and flowthrough mode is more complex than when using a single method, such as IEX, because multiple types of interactions are occurring in ...
Keywords: Chromatography, Indicators

Capto Adhere

Capto adhere is a multimodal strong anion exchanger for BioProcess applications. It was originally designed for post-protein A purification of MAbs at process scale in flowthrough mode. However, Capt...
Keywords: Cell culture, Chromatography, Deamidations, Ion Exchange, Ligands, Purification, Reductions, Separation

HTS and Optimization of a Multimodal Polishing Step in a MAb Purification Process Using Capto Adhere

This application describes the use of Capto adhere and MabSelect SuRe chromatography media to significantly reduce the level of IgG antibody aggregates in a sample using an efficient two-step method....
Keywords: Adsorption, Buffers, Centrifugation, Chromatography, Enzyme-linked immunosorbent assay, Filtration, Ion Exchange, Ligands, Mass spectrometry, Purification, Reductions

Maintenance of Multimodal Chromatography Media and Storage Conditions

For best performance of multimodal chromatography media over a long working lifetime, follow the procedures described below.
Keywords: Antimicrobials, Chromatography, Ligands, Purification, Reductions, Solvents

Optimization of Loading Conditions on Capto Adhere Using DoE

This study describes the optimization of loading conditions for a MAb polishing step to obtain the window of operation for Capto adhere. In order to find the optimal conditions, a full factorial DoE ...
Keywords: Chromatography, Mass spectrometry, Purification

Scale-up of a Downstream MAb Purification Process Using HiScreen and AxiChrom Columns with Capto adhere

The main challenge from the MAb purification process described here was the high incidence of aggregation (12%) in the starting sample. This antibody feed stream was successfully scaled up more than ...
Keywords: Chromatography, Fermentation, Filtration, Ligands, Purification, Reductions

Use of Multimodal Chromatography Media for MAb Purification

Typical MAb purification processes consist of capture by protein A followed by one or two polishing steps (Fig A3.1). MabSelect SuRe is based on a protein A derivative with higher alkali stability co...
Keywords: Chromatography, Ion Exchange, Ligands, Purification, Reductions

Viral Clearance Using Capto Adhere

Viral clearance using Capto adhere was tested with two representative model viruses, Minute Virus of Mice (MVM) and Murine Leukemia Virus (MuLV). Monoclonal IgG1 was purified from CHO cell supernatan...
Keywords: Chromatography, Mass spectrometry, Reductions

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