Download Protein A CIP Resin

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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
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