CM Weak Ion-Exchange Membrane Chromatography

SP Strong Cation Exchange Membrane Chromatography Product Introduction 

 

2. Product Advantages

Fast and Efficient High binding capacity can be achieved at flow rates up to 40 times faster than traditional resin chromatography. Compared with conventional resin-based chromatography, the process time using membrane chromatography can be reduced by 30–40 times. The typical operating flow rate is around 10 MV/min.

2.2 High Binding Efficiency Membrane chromatography exhibits high binding capacity and high flow rates at low pressure drop, enabling charged biomolecules to be captured in a single pass through the module.

2.3 Scalable and Flexible The full range of membrane chromatography products can meet the diverse needs of biomolecule purification, covering applications from process development to large-scale production. The capsule design allows for single-use operation or can be cleaned and reused after proper cleaning procedures.

2.4 Improved Productivity The compact design minimizes facility footprint. By eliminating operations such as column packing, cleaning, cleaning validation, and column storage, processing can begin after simple equilibration with relatively less buffer. Since there is no need for column packing, cleaning, or storage, labor costs can be reduced by more than 50%.

 

 

3 Technical Parameters

3.1 Structural Materials

	Lab scale	small scale	pilot scale	production scale
membrane volume	0.2ml	5ml	140ml	5L
Membrane Support Structure	Polypropylene
membrane housing	Polypropylene
O ring	Silicone

3.2 Operating Characteristics

	Lab scale	small scale	pilot scale	production scale
membrane volume	0.2ml	5ml	400ml	5L
Recommended flow rate	1-6ml/min	25-150ml/min	2-12L/min	25-150L/min
Maximum operating temperature	35℃
Maximum operating pressure	3bar(25℃)
Maximum pressure differential	3bar(25℃)
Storage conditions	20% ethanol aqueous solution

Comparison shows that the service life of SP membrane chromatography is comparable to that of SP Sepharose 6FF.

Figure 1. Binding Capacity Changes of SP Membrane Chromatography After Multiple Uses Tested with Lysozyme

In addition, we evaluated the membrane chromatography for its efficiency in removing host cell proteins and nucleic acids. The results are as follows:

	DNA				HCP
	IgG Recovery	Content(pg/mg of IgG)by RT PCR		Removal Factor	Content(ng/mg of IgG)by Elisa		Removal Factor
Run	%	Before Q Membrane	After Q Membrane	Log	Before Q Membrane	After Q Membrane	Log
1	96.4	423	3.6	2.07	7	4.3	0.21
2	97.4	438	4.3	2.01	7	4.7	0.17
3	94.1	513	5.8	1.95	6	2.3	0.42
4	96.2	32	0.8	1.60	6	3.2	0.27
5	96.3	45	1.9	1.37	8	3.4	0.37
6	96.7	158	2.4	1.82	8	3.5	0.36
7	96.4	267	2.6	2.01	9	6	0.18
8	96.8	298	3.6	1.92	9	7	0.11
9	97.9	746	9.8	1.88	4	1.5	0.43
10	96.2	39	3.2	1.09	4	1.4	0.46

Table 1. DNA and Host Cell Protein Removal Rates in CHO-Expressed IgG Material Using SP Membrane Chromatography

A series of experiments demonstrated that SP membrane chromatography can effectively remove contaminants while maintaining a high recovery rate of the target IgG.

When comparing Gudiling SP membrane chromatography with imported brands, the binding capacity data are as follows:

Binding capacity (mg/mL)	Sartorius	PALL	Guidling
Lysozyme	25	32	29
Trypsin	22	27	25

Table 2. Binding Capacity Performance of Different Proteins in Our Product and Competing Brands

Overall evaluation shows that our binding capacity is comparable to that of imported products.

Figure 2. Binding Capacity Test of SP Membrane Chromatography Module Using Lysozyme as Standard

Compared with dynamic binding capacity and imported products, it was confirmed that most target proteins can be captured when lysozyme is eluted in 190 mM NaCl.

Through different elution conditions, we found that the elution profiles of membrane chromatography are similar to those of agarose gel, but the purity of proteins varies significantly at different salt concentrations. In actual R&D and production, it is necessary to quantitatively determine optimal elution conditions to obtain high-purity target proteins.

 

4 Typical Application Cases

Removal of DNA, viruses, and host cell proteins

Capture of plasmids, viruses, proteins, and purification of oligonucleotides

Removal of pigments from yeast fermentation broth and high-capacity protein capture

 

5 Usage Procedure

5.1 Equipment Preparation and Assembly:

5.1.1：Install the membrane chromatography module on an ÄKTA chromatography system following procedures similar to resin columns, ensuring the flow direction aligns with the module's arrows and the inlet orientation. Connect the module using either Luer locks or clamp-style fittings for secure integration into the system.

5.1.2 Set the feed flow rate to 5–10 MV/min and degas the module using equilibration buffer, ensuring that the effluent is free of air bubbles. Once degassed, connect the permeate outlet to the chromatography system.

5.2：Pre-Use Treatment:

5.2.1：

Set the feed flow rate to 5–10 MV/min and perform pre-treatment with 0.5 M NaOH for more than 5 MV, ensuring the membrane reaches full equilibrium.

5.2.2： At the same flow rate, perform pre-treatment with 1 M NaCl for more than 5 MV to ensure the membrane reaches full equilibrium.

5.3 Chromatography Process

5.3.1 Set the feed flow rate to 5–10 MV/min and equilibrate the membrane with equilibration buffer for more than 5 MV, until the membrane reaches full equilibrium.

5.3.2 After 0.22 μm pre-filtration, load the sample onto the membrane until the sample loading is complete or the chromatographic binding capacity is reached.

5.3.3 Wash with equilibration buffer for more than 10 MV until the UV signal returns to the baseline.

5.3.4 Apply gradient elution or stepwise elution according to the process design, and collect fractions as required.

5.4 CIP Post-Use Treatment – Membrane Chromatography Device CIP (Cleaning in Place)

5.4.1 Set the feed flow rate to 5–10 MV/min and perform cleaning with 1 M NaOH for more than 10 MV, until the UV signal decreases to below the baseline.

5.4.2 After circulating for 30 minutes, switch to water washing until the pH reaches 7–8, then continue cleaning with 20% ethanol until the conductivity becomes nearly constant.

5.5 Membrane Chromatography Storage

After use and completion of CIP, the membrane module can be removed and stored by soaking in 20% ethanol, or it can be stored in-line at room temperature in a solution containing 20% ethanol. The 20% ethanol solution should be inspected and replaced periodically.

 

6. Ordering information

Q Strong Anion Exchange Membrane Chromatography Capsule Filter

	Lab scale	small scale	pilot scale	production scale
Product Model	IEXQ0002ES	IEXQ0050ES	IEXQ0400ES	IEXQ5000ES
Membrane Volume	0.2ml	5ml	400ml	5L

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