General information

Can Cellufine be used with organic solvents i.e., hexane, chloroform, ethyl acetate, etc.?

Cellufine is intended for use in water. Since it is cellulose, it may be resistant to certain organic solvents, but it is not guaranteed to be used.

Can I obtain and evaluate samples for drug manufacturing research?

Samples can be provided for screening. Please contact the following email address.
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Do you have any application examples other than biopharmaceuticals?

There are application examples for purification of food additives, polysaccharides, etc.

Can Cellufine be used in a GMP manufacturing facility?

Yes. Cellufine is used by many pharmaceutical manufacturers.

Please tell me how many times Cellufine is used.

Cellufine evaluates 100 times repeated tests to check for deterioration. The stability with respect to cleaning solution depends on the product. The actual number of times of repeated use also depends on the customer's usage conditions.

Where can I buy Cellufine?

Up to 500 mL for IEC resins and SEC resins or 50 mL for affinity resins for lab use can be purchased from our web shopping site. If the quantity is larger than that, we assume that it will be used for manufacturing facility, so we sell it directly from the viewpoint of quality assurance. Please contact us.
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Can Cellufine be used in manufacturing facility?

Yes.

Please tell me how to scale up and down the column.

Remain the column height the same and change the column inner diameter. In order to keep the adsorption capacity constant, it is necessary to keep the operation flow rate constant. If the linear velocity [cm/h] or residence time [min] is constant, the adsorption amount does not change and stable scale-up can be accomplished.

The linear velocity and residence time can be calculated by the following formulas.
1. Linear velocity [cm/h] = flow rate [ml/min] / column sectional area [cm²] x 60
2. Residence time [min] = Column volume [cm³] / Flow rate [ml/min)

Feature of Cellufine products

The ligand of Cellufine Sulfate is negatively charged due to the sulfate group. What is the difference from the strong cation exchange chromatography medias such as Cellufine MAX S and S-500?

Cellufine Sulfate has a sulfate group, so it is charged negatively. Therefore, it has characteristics as an ion exchanger. On the other hand, since the ligand is localized on the surface, unlike the strong cation exchange chromatography medias, the adsorbed virus does not elute even at a high salt concentration such as 0.1M NaCl. Since the protein elutes under these conditions, it has an optimal surface ligand distribution for virus and protein separation. Also, because it is charged negatively, there is no adsorption of DNA or endotoxin. These characteristics are the reason why Cellufine sulfate are used by pharmaceutical manufacturers around the world.

Is it possible to remove endotoxin from monoclonal antibodies using ET Clean, a chromatography media for endotoxin removal?

There is an example of removal of endotoxin from gamma globulin. For details, please refer to the links below.
ET Clean technical data sheet

ET clean has two lineups, ET clean S and ET clean L. Please tell me the difference between each.

The ligands are the same. The difference is the pore size of the base resin.

 1. Cellufine ET Clean S
The pore size is small and the protein does not enter inside.Therefore, there is little non-specific adsorption and excellent recovery rate is shown.

2. Cellufine ET Clean L　
The large pore size allows proteins to enter inside. Therefore, it shows more ion-exchange protein adsorption activity than ET Clean S. Due to the large surface area, more endotoxin can be adsorbed.

There are four lineups of strong cation exchange chromatography resins. What are the differences between Cellufine MAX S-h, Cellufine MAX S-r, Cellufine MAX GS, and Cellufine S-500?

In both cases, the ligand has a sulfone group, but there are differences in the base resin. 1. Cellufine MAX S-h
Cellufine MAX S-h is used a base resin that achieves high flow rate and high adsorption capacity. In experiments that gamma globulin was adsorbed as a model protein, the adsorbed amount reached 200 mg/mL. On the other hand, it has the characteristic that the elution property is lower than that of Cellufine MAX S-r. Especially when purifying protein with different isoelectric points such as gamma globulin, a large amount of eluate solution is required, but when purifying proteins with a single isoelectric point, sharp elution is shown. The "h" at the end stands for high capacity. 2. Cellufine MAX S-r
Cellufine MAX S-h is used a base resin that achieves high flow rate and high adsorption capacity. Adsorption capacity is lower than that of Cellufine MAX S-h, but it shows sharp elution peak. The “r” at the end stands for good resolution. 3. Cellufine MAX GS
Cellufine MAX S-h is used a base resin that achieves high flow rate and high adsorption capacity. Since the ligands are close to each other by graft polymerization, they show excellent separation even under high salt concentration conditions. Especially, when removing dimers or larger aggregates from monoclonal antibodies, it exhibits superior separation performance compared to ordinary strong cation exchange chromatography resins.　 4. Cellufine S-500
Cellufine S-500 is a general type of strong cation exchanger.

Please tell me about alkali resistance of Cellufine with NaOH as a CIP solution.

Alkali resistance of these resins are depend on the ligand of each product. Ion exchange chromatography resins, gel filtration chromatography resins, and a parts of affinity chromatography resins can be used stably with 0.5M NaOH. Please contact us for details.

There are three types of strong anion exchange chromatography resins. What are the differences between Cellufine MAX Q-h, Cellufine MAX Q-r, and Cellufine Q-500?

Features of each Cellufine resins are below.
1. Cellufine MAX Q-h
Cellufine MAX Q-h is used a base resin that achieves high flow rate and high adsorption capacity. When bovine serum albumin is used as a model protein, the adsorption capacity reaches 200 mg/ml. On the other hand, compared to Cellufine MAX Q-r, it has the characteristic of low elution. The "h" at the end stands for high capacity. 2. Cellufine MAX Q-r
Cellufine MAX Q-r is used a base resin that achieves high flow rate and high adsorption capacity. Compared with Cellufine MAX Q-h, the adosorption capacity is low, but it shows sharp elution peak. The “r” at the end stands for good resolution. 3. Cellufine Q-500
Compared to ordinary strong anion exchange chromatography resins, it has a unique ligand structure that provides high adsorption capacity under conditions of high salt concentration.

What is the difference between A-200, A-500 and A-800 as anion exchange chromatography resins?

There are differences of pore size. Therefore, each resin has different characteristics.
1. Cellufine A-200
Proteins tend to adsorb on the surface and show sharp elution properties. 2. Cellufine A-500
Cellufine A-500 is a general type anion exchange chromatography resin. 3. Cellufine A-800
Cellufine A-800 has a large pore size and is excellent in adsorbing large soluble proteins such as thyroglobulin ,molecular weight 660 kDa.

Can Cellufine be used at low temperature conditions?

It can be used. At low temperatures, the viscosity of the mobile phase increases. Also, be careful with salt precipitation from the mobile phase for hydrophobic interaction chromatography used at high salt concentrations.

Column packing

Please tell me the standard number of theoretical plates when Cellufine resins are packed to the column.

The optimum packing condition depends on the manufacturing equipment. According to our in house experiments, theoretical plate number became 3000 N/m to 6000 N/m. The number of theoretical plates varies depending on the product.

Virus and vaccine purification

It seems that Cellufine Sulfate, Cellufine MAX DexS-VirS, and Cellufine MAX DexS-HbP can be used for the purification of viruses and vaccines. What are their characteristics?

Cellufine has three products as chromatography resin that immobilized sulfate ester for virus and vaccine purification as a ligand. The features of each are as follows. 1. Cellufine Sulfate
Cellufine sulfate is a resin in which sulfate ester groups are immobilized on cellulose. Since the pore size is narrow and proteins do not enter the pores, non-specific adsorption can be suppressed. Cellufine Sulfate is used in many pharmaceutical manufacturers for vaccine purification. 2. Cellufine MAX DexS-VirS
Cellufine MAX DexS-VirS is immobilized dextran sulfate as a ligand. The large pore size allows proteins to enter the pore. Since the base resin is highly crosslinked, it has high pressure resistance and liquid permeability. Due to the large particle surface area, the adsorption capacity of virus is higher than that of Cellufine Sulfate. The “VirS” at the end stands for specialized for virus purification. 3. Cellufine MAX DexS-HbP
Cellufine MAX DexS-HbP is immobilized dextran sulfate as a ligand. The large pore size allows proteins to enter the pore. Since the base resin is highly crosslinked, it has high pressure resistance and liquid permeability. The density of modified ligand is different from that of Cellufine MAX DexS-VirS. Therefore, heparin-binding proteins such as serum-derived; anti-thrombin III and factor IX can be adsorbed more favorably than viruses. The “HbP” at the end stands for specialized for heparin binding proteins.

Is it possible to purify baculovirus with Cellufine Sulfate?

Unfortunately, no information is available, but there are reports of purification cases using heparin-immobilized resin. Cellufine Sulfate is a resin that imitates a heparin-immobilized resin by chemical synthesis, so it may be adsorbed.

Can Cellufine Sulfate be purified live and inactivated viruses and split proteins?

There are examples for both live and inactivated viruses. There are examples of purification using virus surface proteins too, but we would like to confirm if you can actually use Cellufine Sulfate.

What viruses can I purify withCellufine Sulfate or Cellufine MAX DexS-VirS?

Viruses which have envelope and heparin-binding virus can be purified by these resins. Adsorption activity to many viruses such as influenza virus, rabies virus, coronavirus, human immunodeficiency virus, lentivirus vector, Japanese encephalitis virus, West Nile virus, dengue virus, herpes simplex virus, hepatitis B virus has been reported. Although it does not have an envelope, it has also been reported to have an adeno-associated virus adsorption activity.

Does Cellufine Sulfate have adsorption activity for the new coronavirus; SARS-CoV-2?

Coronavirus is known to have adsorbing activity to heparin sulfate. Cellufine Sulfate is a chromatography resin that imitates heparin sulfate by chemical synthesis, so it seems to have adsorption activity to SARS-CoV-2.

What are the points to note when purifying viruses prepared by cell culture with Cellufine Sulfate?

In the case of cell culture, DNA derived from host cells may affect adsorption to the resin. Since DNA is negatively charged, it does not adsorb to Cellufine Sulfates that have sulfate ester groups. On the other hand, if the virus adsorbs the host DNA, it may cancel the positive charge. In this case, it may not be adsorbed normally. In this situation, it may be solved by diluting the load sample by adequate buffer.

What is the recommended buffer for Cellufine Sulfate?

As the adsorption buffer of Cellufine Sulfate, 10 mM phosphate buffer containing 0.15 mol/L NaCl pH 7 is often used. Since it can be operated at neutral pH, inactivation of virus can be suppressed.