Add Value to Your Antibody Drug Production
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Cation-exchange chromatography Anion-exchange chromatography Virus filter UF/DF Cell culture Centrifuge Protein A Add Value to Your Antibody Drug Production Protein A CIP Resin Robust Dynamic Binding Capacity and High Recovery Rate
Transcript of Add Value to Your Antibody Drug Production
Cation-exchangechromatography
Anion-exchangechromatography
Virus filter
UF/DF
Cell culture
Centrifuge
Protein A
Add Value to YourAntibody Drug Production
Protein A CIP ResinRobust Dynamic Binding Capacity and High Recovery Rate
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Protein A CIP Resin-0.1M NaOHProtein A CIP Resin-0.5M NaOHMabselect SuRe-0.1M NaOHMabselect SuRe-0.5M NaOH
Protein A CIP ResinA 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.
• 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
• 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
Key Features:
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.
Protein A CIP Resin provides more CIP stability and higher dynamic binding capacity than other suppliers
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of Ig
G)
Product Characteristics:
Low ligand leakage under purification/ CIP cycles
Excellent stability and reproducibility of the Protein A CIP Resin performance under different resident time (Column: C16/ 20 packed with 40 ml of Resin)
Good dynamic binding capacity performance under different resident time
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 StandardLane 1, 3: Purified antibody under reducing conditionsLane 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.
Lower non-specific binding, and higher antibody purity
Product Format
Composition
Average Particle Size
Ligand
Dynamic Binding
Capacity (DBC)
Ligand Leakage
Pressure/Flow Specification
Recommended Flow Rate
Chemical Stability
pH Working Range
CIP Stability
Storage
Available in multiple package sizes with 50% slurry
Highly cross-linked 4% agarose
~90 μm
Alkali-tolerant recombinant protein A (E. coli)
50 mg human lgG/ ml
(4 min RT with sample hIgG concentration at 5 mg/ml)
<10 ng/mg
0.3 MPa/ ~1200 cm/h
50 to 300 cm/h
Stable in all commonly used buffers
3-12
0.1-0.5 M NaOH
20% ethanol, 2-8℃
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reak
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(mg/
ml)
Residence Time (min)
1 mg/ml
2 mg/ml
3 mg/ml
4 mg/ml
5 mg/ml
Cat. No.
L00433-11
L00433-15
L00433-51
L00433-55
L00433-25
L00433-200
L00433-1
L00433-5
L00433-10
L00433-c
Product Name
Protein A CIP Resin Prepacked Column
Protein A CIP Resin Prepacked Column
Protein A CIP Resin Prepacked Column
Protein A CIP Resin Prepacked Column
Protein A CIP Resin
Protein A CIP Resin
Protein A CIP Resin
Protein A CIP Resin
Protein A CIP Resin
Protein A CIP Resin
Size
1 ml
5 × 1 ml
5 ml
5 × 5 ml
25 ml
200 ml
1 L
5 L
10 L
Custom
Related products * Bulk order available
Cat. No.
L00430
L00210
L00400
L00209
L00239
L00350
L00351
Product Name
Protein A ELISA Kit
Protein A Resin
Ultra Protein A Resin
Protein G Resin
Protein L Resin
ToxinSensorTM
Chromogenic LAL Endotoxin Assay Kit
ToxinSensorTM
Gel Clot Endotoxin Assay Kit
Size
1 Kit
5 ml*
5 ml*
5 ml*
2.5 ml*
1 Kit
1 Kit
Cost Efficient Solution of Bioprocess
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. All content described by GenScript is copyright of GenScript Corporation unless specifically identified otherwise. This includes all imagery, text and programmatic computer code.
