GE17-5438-02

MabSelect^™ SuRe^™

Cytiva 17-5438-02, pack of 200 mL

• Synonym(s): protein A affinity medium, affinity chromatography media
• UNSPSC Code: 41106500
• NACRES: NA.56

Properties

• ligand: alkali-stabilized protein A-derived (E. coli)
• packaging: pack of 200 mL
• manufacturer/tradename: Cytiva 17-5438-02
• storage condition: (20% Ehtanol)
• 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
• working range: 3-12
• capacity: ≥30 mg binding capacity (humanlgG/ml at 2.4 min residence time)
• suitability: suitable for bioprocess medium
• storage temp.: 2-8°C

Description

General description

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.

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.

pH below 3 is sometimes required to elute strongly bound IgG species. However, protein ligands may hydrolyze at very low pH.

pH below 3 is sometimes required to elute strongly bound IgG species. However, protein ligands may hydrolyze at very low pH.

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

Storage and Stability

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.

Analysis Note

To view the Certificate of Analysis for this product, please visit www.cytiva.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 Cytiva company and its licensed distributors. Any other use will require a separate license from a Cytiva company.

MabSelect is a trademark of Cytiva

SuRe is a trademark of Cytiva

Safety Information

• Pictograms: GHS02
• Signal Word: Warning
• Hazard Statements: H226
• Precautionary Statements: P280 - P210 - P241 - P235 - P303 + P361 + P353 - P501
• Storage Class Code: 3 - Flammable liquids