Organization of BMCP Storage

When receiving biomedical cell products (BMCP), there is a problem of preservation of these products during the registration period, as well as ensuring the preservation of their properties during the entire estimated period of storage.

According to the FZ 180 “On biomedical cell products”  biological material, cells for preparation of cell lines, cell lines intended for production of biomedical cell products, biomedical cell products should be stored in conditions of biobanks, ensuring preservation of their biological properties and preventing their infection and pollution.

Biobank is a specialized сryorepository of biological materials. BMCP storage can be carried out by all subjects of BMСP circulation.  One of the most famous biobanks in Russia is the biobank of St. Petersburg State University, which stores about 13 153 samples of biomaterial from 1 824 donors.[3]

What is Cryorepository?

Cryorepository is a type of biorepository where the preservation of biological material is provided by cryoconservation. Cryopreservation (Krios from Greek. – “Frost”) implies preservation of cells at deep freezing (-140°С and below), which can be ensured by liquid nitrogen (-196°С). In such frozen condition an exchange and  biochemical reactions stop and there is no liquid phase in the cells. The cell is in the so-called state of anabiosis. These conditions are optimal for the long-term storage of the biological system and its subsequent return to its original condition when returning to normal temperature. [4]

For example, a allogeneic aortic valve (ALLOGRAFT) is stored that way. It is made from the heart of donor, who died in the accident. It is interesting to note that at the moment the valve has the status of medical devicein Russia and has a valid registration certificate.

It should be said that cryopreservation is able to damage the cells by forming intracellular ice and by dehydration of cells. Intracellular ice leads to an increase in the internal volume of membrane structures, as a result of which cells can “burst”.  The loss of water cell occurs due to freezing of water in the external environment and increasing the concentration of dissolved substances in the external environment, which leads to the removal of moisture from the cell. It’s dehydrated. In this connection it is necessary to add special substances – cryoprotectants.

There is a wide range of cryoprotectants. Their composition is selected individually, depending on the characteristics of the biomaterial. For example, in the process of conservation of ALLOGRAFTA there used a solution of albumin, dimethyl sulfoxide and heparin in the nutrient environment RPMI-1640.

Returning to the issue of biobanks, it should be noted that the general requirements for the Organization and activities of biobanks are regulated by Order 842 N. According to this Order, the safety of BMСP should be ensured by proper:

  • Temperature-humidity regime
  • Sanitary and hygienic regime
  • Light mode

However, this Order gives only general instructions for the organization of storage of BMCP. This is due to the fact that each specific BMCP requires compliance with individual conditions.

Links:

[1] Глотов А.С. БИОБАНК СПБГУ КАК РЕСУРС ДЛЯ ПРОВЕДЕНИЯ ИССЛЕДОВАНИЙ В ОБЛАСТИ ТРАНСЛЯЦИОННОЙ БИОМЕДИЦИНЫ, МОЛЕКУЛЯРНАЯ ДИАГНОСТИКА 2017

сборник трудов IХ Всероссийской научно-практической конференции с международным участием. 2017

[2] Назаренко Л.Н. Некоторые особенности криосохранения биологических объектов ВЕСТНИК МОСКОВСКОГО ГОРОДСКОГО ПЕДАГОГИЧЕСКОГО УНИВЕРСИТЕТА. СЕРИЯ: ЕСТЕСТВЕННЫЕ НАУКИ

[3] Глотов А.С. БИОБАНК СПБГУ КАК РЕСУРС ДЛЯ ПРОВЕДЕНИЯ ИССЛЕДОВАНИЙ В ОБЛАСТИ ТРАНСЛЯЦИОННОЙ БИОМЕДИЦИНЫ, МОЛЕКУЛЯРНАЯ ДИАГНОСТИКА 2017

сборник трудов IХ Всероссийской научно-практической конференции с международным участием. 2017

[4] Назаренко Л.Н. Некоторые особенности криосохранения биологических объектов ВЕСТНИК МОСКОВСКОГО ГОРОДСКОГО ПЕДАГОГИЧЕСКОГО УНИВЕРСИТЕТА. СЕРИЯ: ЕСТЕСТВЕННЫЕ НАУКИ