The Medsintez Plant has launched the full cycle production of the world's first registered drug of recombinant human albumin

In 2024, the Medsintez Plant in collaboration with Tonghua Anrate Biopharmaceutical Co. launched the production of the substance and finished dosage forms of the world's first registered drug of recombinant human albumin. The drug was obtained using Pichia Pastoris cells by the recombinant DNA technology.

Human albumin is the most abundant protein component in human plasma, accounting for 60% of total plasma protein. The main functions of albumin are transport, maintaining constant colloid osmotic pressure and providing cells with amino acids. Albumin binds and dissolves various compounds, such as bilirubin, calcium and fatty acids.

Structural and functional properties of the recombinant albumin are identical to natural human albumin isolated from blood plasma and have the same biological activity. The production of recombinant human albumin is free from the disadvantages characteristic of natural albumin obtained by fractionation of donor blood plasma, namely, there is no risk of contamination with infectious agents such as hepatitis viruses, human immunodeficiency viruses, etc., and no possibility of additional contaminations such as concomitant blood plasma proteins (fractions of α-, β- and γ-globulins). The production of recombinant albumin does not depend on the number of donors and allows the drug to be produced on a large scale. In terms of immunogenicity, recombinant human albumin has shown a low probability of producing antibodies to it.

Albumin is able to quickly restore and maintain circulating blood volume, which is vital for patients suffering from acute blood loss due to injury or surgery. Albumin also stabilizes Colloid Osmotic Pressure: It helps prevent edema and ensures effective perfusion of important organs, maintaining adequate arterial pressure and cardiac function. In addition, albumin can serve as a carrier for various drugs, ensuring their transportation and distribution to tissues and organs.

It is worth noting the convenience of packaging of the drug — a five-layer single-use polyethylene container with one sterile port of 50 and 100 ml. This container ensures the preservation of the properties of the infusion solution during long shelf lives due to better barrier properties of the five-layer polyethylene film. Polymer containers with infusion solution weigh much less and take significantly less volume during storage and transportation compared to traditional glass packaging. The polymer container, unlike the glass bottle, does not break, which eliminates the risk of injury to patients and medical staff. Currently, there are no equivalents of this drug in the world with the possibility of use in the specified volumes.

Thus, high-strength, elastic and lightweight polymer packaging makes it possible and more accessible to use the drug Recombinant Human Albumin in various, sometimes difficult, extreme conditions, when providing emergency medical care, and allows the use of solutions in the field conditions.

High-tech Russian production at the Medsintez Plant ensures a high level of quality and safety of the manufactured drug. The production capacity of the enterprise allows matching 100% of Russia's needs for recombinant human albumin.