What is the Role of Ultrafiltration in Biopharmaceutical Applications?

Tangential Flow Filtration (TFF), or ultrafiltration, is a filtration operation that has been widely adopted. Its applications include clarification filtration, product concentration, pyrogen removal, small molecular impurity removal, desalting and buffer exchange, etc. Ultrafiltration has a wide range of applications in biopharmaceuticals, such as clarification filtration, product concentration, desalting and buffer exchange.

Ⅰ. What are the applications of ultrafiltration?

1. Ultrafiltration is used in the separation, purification, concentration, desalination and dealcoholization of biochemical products (thymosin, heparin sodium, cytochrome C, etc.).

2. Ultrafiltration is used in the separation, purification, concentration and desalination of genetically engineered products (interferon, EPO, TPO, G-CSF, etc.).

3. Ultrafiltration is used in the separation, concentration and dealcoholization of plasma proteins (albumin, globulin, coagulation factors, etc.).

4. Ultrafiltration is used in the separation and concentration of cell culture products (viruses, antibodies, etc.).

5. Ultrafiltration is used for buffer exchange before and after chromatography of protein products or before lyophilization.

6. Collection of cells, bacteria and viruses.

7. Ultrafiltration is used in the clarification of fermentation broth or culture broth to remove bacteria and cell debris.

8. Depyrogenation of small molecule products (such as glucose, antibiotics, small peptides, etc.).

Ⅱ. The role of ultrafiltration in biopharmaceutical applications

When the water passes through the ultrafiltration membrane, most of the colloidal silicon contained in the water can be removed, and a large amount of organic matter can be removed at the same time. The ultrafiltration micropore is less than 0.01 micron, which can completely filter out bacteria, rust, colloids and other harmful substances in the water, and retain the original trace elements and minerals in the water.

The ultrafiltration membrane has a small molecular weight cutoff of 500 Daltons, and can be used to separate proteins, enzymes, nucleic acids, polysaccharides, polypeptides, antibiotics, viruses, etc. in biopharmaceuticals. The advantages of ultrafiltration are that there is no phase transfer, no need to add any strong chemical substances, it can be operated at low temperature, the filtration rate is fast, and it is easy to do aseptic processing. All of this simplifies the separation procedure and avoids loss of viability and denaturation of biologically active substances. Therefore, ultrafiltration is often used in the desalination, concentration, fractionation of macromolecular substances and the exchange balance of solvent systems. Ultrafiltration is also widely used in the depyrogenation treatment of biochemical preparations or other preparations. Ultrafiltration technology has become an indispensable powerful tool in the fields of pharmaceutical industry, food industry, electronic industry and environmental protection.