GE17-5474-01

MabSelect SuRe^™ LX

Cytiva 17-5474-01, pack of 25 mL

• Synonyme(s) : Protein purification resin
• Code UNSPSC : 41106500
• Nomenclature NACRES : NA.56

Propriétés

• ligand: alkali-stabilized protein A-derived (E. coli)
• Conditionnement: pack of 25 mL
• Fabricant/nom de marque: Cytiva 17-5474-01
• Conditions de stockage: (20% Ehtanol)
• Matrice: highly cross-linked agarose
• Taille moy. des particules: 85 μm (d₅₀v is the median particle size of the cumulative volume distribution)
• cleaning in place: 2-13.7
• working range: 3-12
• Capacité: ~60 mg binding capacity
• Adéquation: suitable for bioprocess medium
• Température de stockage: 2-8°C

Description

Description générale

MabSelect^™ SuRe^™ LX is a protein A affinity medium with very high dynamic binding capacity at extended residence times and is developed for high titer antibody processes. Alkali tolerance, high capacity and low ligand leakage in combination with the rigid base matric makes MabSelect^™ SuRe^™ LX highly suitable for purification of monoclonal anitbodies for clinical applications.

MabSelect^™ SuRe^™ LX is a member of the MabSelect^™ family of affinity chromatography media for the capture of monoclonal antibodies (MAbs) at process scale. MabSelect^™ SuRe^™ LX shares features and benefits of MabSelect^™ and MabSelect^™ SuRe^™ 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. It also features the same alkali-tolerant rProtein A ligand as MabSelect^™ SuRe. 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. Process economy is also improved by the increased dynamic binding capacity of MabSelect^™ SuRe^™ LX.

Just as for MabSelect^™ SuRe, the novel ligand construct of MabSelect^™ SuRe^™ LX has been proven to have an increased stability towards proteases. Therefore, the level of leakage of the MabSelect^™ SuRe^™ LX ligand during elution is low.

MabSelect^™ SuRe^™ has been demonstrated to give generic elution conditions for different monoclonal antibodies which can be applied also to MabSelect^™ SURe LX since it utilizes the same ligand. This is an advantage when designing generic purification platform processes. The feature is also correlated to the construction of the MabSelect^™ SuRe^™ ligand.

MabSelect^™ SuRe^™ LX 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.

human IgG/ml medium. Determined at 10 % breakthrough by frontal analysis at a mobile phase velocity of 100 cm/h in a column with a bed height of 20 cm, i.e. residence time is 6.0 min.

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.

Caractéristiques et avantages

• 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 performance and reduces overall costs
• High dynamic binding capacity (DBC) for high titer cultures reduces process time and amount of medium used
• Generic elution profile for different monoclonal antibodies enables platform approach to purification
• High-flow agarose matrix allows the processing of large feed volumes

Stockage et stabilité

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.

Remarque sur l'analyse

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

Informations légales

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

MabSelect SuRe is a trademark of Cytiva

SuRe is a trademark of Cytiva

Informations sur la sécurité

• Pictogrammes: GHS02
• Mention d'avertissement: Warning
• Mentions de danger: H226
• Conseils de prudence: P280 - P210 - P241 - P235 - P303 + P361 + P353 - P501
• Code de la classe de stockage: 3 - Flammable liquids