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Download Protein A CIP Resin
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Add Value to Your Antibody Drug Production Cell culture Centrifuge Protein A Cation-exchange chromatography Anion-exchange chromatography Virus filter UF/DF Protein A CIP Resin Robust Dynamic Binding Capacity and High Recovery Rate Protein A CIP Resin A highly reliable and alkali-stable Protein A media for capture of monoclonal antibodies at Process Scale Protein A based affinity chromatography is the process scale capture step for antibodies due to the excellent selectivity and suitability for platform separations. There are a few factors of concern when using protein A resins for process scale antibody purification, with the major issue being the high cost of resin followed by protein A ligand leakage, resin lifetime and performance, especially resin stability after extensive Clean-in-Place (CIP) procedures. Genscript’s Protein A CIP Resin (Cat. No. L00433) is made of novel recombinant protein A as ligand, which not only keeps the specific binding capacity to Fc region of immunoglobulin molecules, but also enhances chemical stability greatly Cleaning-in-place (CIP) conditions. The average dynamic binding capacity (DBC) is over 50 g human IgG/ L settled resin, with no significant decrease of binding capacity after purification/CIP for 200 cycles. The Protein A CIP Resin has an extremely low leakage of ligand (<10 ng/mg IgG) over a number of purification/ CIP cycles. Key Features: Protein A CIP Resin provides more CIP stability and higher dynamic binding capacity than other suppliers • Robus IgG binding capacity Binding capacity of >50 mg human IgG/ml of settled resin (5’ RT, 300 cm/ h linear speed) • Enhanced alkali stability No significant decrease of binding capacity after CIP with 0.1 M NaOH for 200 cycles; The resin retains 80% of its initial binding capacity after CIP with 0.5 M NaOH for 100 cycles 60 50 40 30 Protein A CIP Resin-0.1M NaOH Protein A CIP Resin-0.5M NaOH Mabselect SuRe-0.1M NaOH Mabselect SuRe-0.5M NaOH 20 10 0 • Good pressure resistance Made with rigid base matrix, can withstand pressure up to 0.3 MPa • Industry leading ligand leakage The leakage is less than 10 ng ligand (protein A)/ mg purified human IgG • Package/ Size Available in customized size, 1 ml and 5 ml prepacked column 0 20 40 60 80 100 150 200 Changes of the dynamic binding capacity of Protein A CIP Resin during 200 Cleaning-in-place cycles with 0.1 M or 0.5 M NaOH. Cleaning-in-place is to remove very tightly bound, precipitated or denatured substances from the purification system. The accumulation of such contaminants may affect the chromatographic properties of the column, the capacity of the column and, potentially, the quality of purified antibody in subsequent purifications. Genescript Protein A CIP Resin guarantees no significant decrease of binding capacity after CIP with 0.1 M NaOH for 200 cycles. Mabselect SuRe is a trade mark of GE Healthcare. Low ligand leakage under purification/ CIP cycles Lower non-specific binding, and higher antibody purity Leakage (ng/mg of IgG) 40.00 30.00 20.00 10.00 0.00 1 20 40 60 80 100 150 200 Cycle No. Protein A ligand leakage analysis Fractions collected from the purification were analyzed by sandwich ELISA (L00430, Protein A ELISA Kit, GenScript), in triplicate, from four batches. With enhanced alkaline stability, the Protein A CIP Resin has a low leakage of ligand (<10 ng ligand/ mg IgG) over a number of purification/ CIP cycles. The efficiency of downstream purification steps would be significantly improved for further purification steps to eliminate protein A ligand contamination will not even be needed to meet FDA’s residue ligand standard when the concentration of ligand is only 1 to 3 ppm. Lane M: Protein Standard Lane 1, 3: Purified antibody under reducing conditions Lane 2, 4: Purified antibody under non-reducing conditions Like GenScript’s other recombinant Protein A affinity purification resin, the Protein A CIP Resin uses the same highly-crosslinked 4% beaded agarose as the base matrix. The hydrophilic nature of the agarose ensures low levels of non-specific binding, resulting in significantly reduced levels of contamination from lipids, DNA or other proteins. In addition, the bacteria derived recombinant Protein A ligand eliminates any contamination from animal serum, making the Protein A CIP Resin to meet the requirement of antibody drug production. DBC at 10% Breakthrough (mg/ml) Good dynamic binding capacity performance under different resident time Product Characteristics: 70.0 40.0 20.0 0.0 2.4 4 6 8 12 Product Format Available in multiple package sizes with 50% slurry Composition Highly cross-linked 4% agarose 1 mg/ml Average Particle Size ~90 μm 2 mg/ml Ligand Alkali-tolerant recombinant protein A (E. coli) 3 mg/ml Dynamic Binding 50 mg human lgG/ ml 4 mg/ml Capacity (DBC) (4 min RT with sample hIgG concentration at 5 mg/ml) 5 mg/ml Ligand Leakage <10 ng/mg Pressure/Flow Specification 0.3 MPa/ ~1200 cm/h Recommended Flow Rate 50 to 300 cm/h Chemical Stability Stable in all commonly used buffers pH Working Range 3-12 CIP Stability 0.1-0.5 M NaOH Storage 20% ethanol, 2-8℃ 24 Residence Time (min) Excellent stability and reproducibility of the Protein A CIP Resin performance under different resident time (Column: C16/ 20 packed with 40 ml of Resin) Cost Efficient Solution of Bioprocess Cat. No. Product Name Size L00433-11 Protein A CIP Resin Prepacked Column 1 ml L00433-15 Protein A CIP Resin Prepacked Column 5 × 1 ml L00433-51 Protein A CIP Resin Prepacked Column 5 ml L00433-55 Protein A CIP Resin Prepacked Column 5 × 5 ml L00433-25 Protein A CIP Resin 25 ml L00433-200 Protein A CIP Resin 200 ml L00433-1 Protein A CIP Resin 1L L00433-5 Protein A CIP Resin 5L L00433-10 Protein A CIP Resin 10 L L00433-c Protein A CIP Resin Custom Related products * Bulk order available Cat. No. Product Name Size L00430 Protein A ELISA Kit 1 Kit L00210 Protein A Resin 5 ml* L00400 Ultra Protein A Resin 5 ml* L00209 Protein G Resin 5 ml* L00239 Protein L Resin 2.5 ml* L00350 ToxinSensor Chromogenic LAL Endotoxin Assay Kit 1 Kit L00351 ToxinSensorTM Gel Clot Endotoxin Assay Kit 1 Kit TM www.genscript.com 860 Centennial Ave., Piscataway, NJ 08854, USA | Toll-Free: 1-877-436-7274 | Tel: 1-732-885-9188 | Fax: 1-732-210-0262 | Email: [email protected] All Rights Reserved. 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