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Injection-grade recombinant human serum albumin

Human serum albumin (HSA) is the earliest blood product extracted from human plasma and has achieved large-scale production and application, with a clinical application history of over 70 years. In each liter of plasma, the concentration of human serum albumin can reach 35-55g, accounting for 60% of total plasma protein. Human serum albumin is synthesized by hepatocytes. Its molecular structure is a single-chain polypeptide containing 585 amino acid residues, with a molecular weight of 66438. The molecule contains 17 disulfide bonds and 1 free sulfhydryl group, and is not glycosylated.

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Propylene glycol quaternary ammonium salt disinfectant

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Human serum albumin (HSA) is the first blood product extracted from human plasma to achieve large-scale production and application, with a clinical application history of over 70 years. In each liter of plasma, the concentration of human serum albumin can reach 35-55g, accounting for 60% of the total plasma protein.

Diagram of Human Serum Albumin Molecular Structure

The main physiological functions of human serum albumin are:

1. Increase blood volume and maintain plasma colloid osmotic pressure. Human serum albumin accounts for 80% of plasma colloid osmotic pressure, mainly regulating the dynamic balance of water between tissues and blood vessels. Due to the high molecular weight of human serum albumin, compared with salts and water, its transmembrane speed is slower, making the colloid osmotic pressure of human serum albumin counterbalance the hydrostatic pressure of capillaries, thereby maintaining normal and constant blood volume;

2. Transport and detoxification. Human serum albumin can reversibly bind various metal ions, hormones, enzymes, drugs, and toxin molecules, and can transport these substances to different tissues and organs according to different physiological needs;

3. Nutritional supply. Tissue proteins and plasma proteins can be interconverted. In case of nitrogen metabolism disorders, human serum albumin can serve as a nitrogen source to provide nutrition for tissues.

In clinical practice, human serum albumin is mainly used for the following indications:

1. Shock caused by hemorrhagic trauma and burns;

2. Maintenance therapy for patients with advanced cancer;

3. Increased intracranial pressure caused by cerebral edema and injury;

4. Edema or ascites caused by cancer, cirrhosis, and nephropathy;

5. Prevention and treatment of hypoproteinemia;

6. Neonatal hyperbilirubinemia;

7. Adjunctive therapy for cardiopulmonary bypass, burns, or hemodialysis, and adult respiratory distress syndrome.

In the field of biomedicine, human serum albumin can not only be used as a drug for direct intravenous injection, but also as an excellent drug carrier to prolong the in-vivo half-life of the drug, achieving long-acting effects. It can also be used as a stabilizer for vaccines and other biological preparations, or as a culture medium for CHO cells and others.

The research and development of human serum albumin began during World War II. To rescue the wounded, Professor Cohn and others from Harvard Medical School successfully purified albumin from human plasma in January 1942 for use in rescuing war casualties. Because the use of human serum albumin does not require blood type matching, clinical application is very convenient, saving a large number of casualties. Currently, pharmaceutical human serum albumin is entirely extracted from human plasma, and there are two main problems:

One is the risk of infection with known or unknown viruses such as hepatitis, AIDS, and coronaviruses. On November 15, 2004, Xinhua News Agency reported that Henan Province conducted the largest "dragnet" survey of 280,476 people who had previously paid for blood donations in 51,187 administrative villages or residential committees, resulting in the detection of 25,036 HIV-infected individuals, with 11,815 current patients. According to Sina.com, in the first 10 months of 2013, more than 60,000 people in Nanjing participated in voluntary blood donation, and 14 people were found to be infected with HIV, with the detection rate increasing year by year. In 2012, researchers from the Guangzhou Blood Center published a paper in the Tropical Medicine Journal (2012, No. 07) pointing out that there is latent hepatitis B virus infection among HBsAg-negative blood donors. In May 2024, British Prime Minister Sunak publicly apologized for the "blood contamination scandal" for the "failures" of successive governments in his country, calling this day a "national day of shame" for Britain. It is clear that the potential risk of viral infection in raw plasma is extremely high.

Second, there is a shortage of raw plasma, often resulting in a blood shortage, making it difficult to obtain injectable albumin. For many years, the global amount of plasma collected has not been able to meet the clinical demand for drugs. Because paid blood donation leads to a much higher risk of viral infection than voluntary blood donation, most countries have gradually abolished the paid blood donation system, leading to a further decrease in the amount of blood collected, even resulting in blood shortages. Albumin is China's most urgently needed large-volume drug. Due to the long-term shortage of plasma in China, more than 60% of the domestic albumin market share has long relied on imports. In 2023, the amount of human serum albumin approved in China was approximately 78.1 million bottles, with a year-on-year increase of 15.4%. Among them, imported albumin accounted for 66.3%, while domestically produced albumin accounted for only 33.7%, and the market share of imported albumin showed a continuous upward trend.

Protgen uses a yeast expression system to produce injectable recombinant human serum albumin, which is not limited by the supply of blood sources and can completely avoid problems such as viral contamination. This can guarantee clinical drug use, meet major social needs, and has broad market prospects. Through the optimization of all process steps in the early stage, an economical, efficient, stable, controllable, and linearly scalable preparation process for recombinant human serum albumin has been established.

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