GMP-compliant production of albumin starts in the Lipetsk region

| By | Drug Manufacturing, Russian GMP

On January 26, the head of the region, Oleg Korolev gave the official start to the manufacturing of albumin at the Lipetsk regional blood transfusion station.

Last year, following the overhaul and reconstruction of its premises, and installation of special equipment, Lipetsk regional blood transfusion station received a certificate of compliance with the Russian GMP standard.

The blood service of the Lipetsk region is a dynamically developing health care institution that combines the functions of a health care organization for the procurement, processing, storage and safety of the donor blood and its components and the functions of the enterprise for manufacturing the medicinal products from donor blood (albumin). The medical institution is completely self-sufficient in donor plasma, as it annually collects more than 30 tons of the whole blood, more than 12 tons of fresh frozen plasma, and 6 tons of red blood cell-containing components.

Among 85 subjects of the Russian Federation, Lipetsk region is one of the few that manufacture the albumin. The others include Bryansk, Vologda, Nizhny Novgorod, Ivanovo, Samara, Pervouralsk, Tambov, Tyumen, and Chelyabinsk. At the same time, Lipetsk regional blood transfusion station is the only medical institution with a certificate of compliance to the national GMP standard. Overall, Russia manufactures about 30 tons of albumin a year, including 3 tons produced in Lipetsk.