Currently, there is data on the development and patenting of more than 700 biomedical cell products (BMСP) for the treatment and prevention of various diseases. Of course, each of them should be an effective and high-quality product. According to the definition of FZ 180 “On Biomedical Cell Products” Quality of biomedical cell product is the correspondence of biomedical cell product to the requirements of normative documentation for biomedical cell product. What quality indicators should include normative documentation so that the product can be considered of high-quality?

The answer to this question is not an easy task, because the composition of BMCP varies depending on the application, method of preparation and other parameters. However, there are a number of common quality indicators that characterize all types of BMCP.

1. Identification

Product identification is a set of characteristic, specific indicators that distinguish this product from others. These indicators can be divided into three groups: Genetic, biochemical and morphological.

2. Specific activity

The confirmation of this group of quality indicators depends on a number of factors including:

– method of preparation

– composition

– Application of BMCP

For example, the specific activity of BMCP, intended to restore the ischemic area of the tissue, will be determined by the output of the substances required for this recovery.

3. The absence of all types of microorganisms in BMCP.

This indicator is confirmed on special selective media in anaerobic and aerobic growth conditions at temperatures 30 and 37 ˚ with incubation duration from 24 hours to 3 days.

4. Cell viability

The confirmation of this indicator is carried out by colouring of cells by trypan blue with subsequent counting of painted and unpainted cells. Living cells are not painted. The BMCP is considered to be of proper quality if it contains 70-90% of living cells.

5. Stability

Compliance with this indicator is determined by many criteria depending on the indication of BMCP. Stability can be determined by the average size of cells, their grain, viability, etc.

Thus, despite all the diversity of prospective BMCPs, it is possible to highlight overall quality indicators for all product groups. While individual characteristics will exist within each group of indicators and methods of their definition, manufacturers and developers are given a vector to prepare the necessary documentation for registration purposes.

References:

1. FZ #180
2. Супотницкий М.В., Елапов А.А., Борисевич И.В., Климов В.И., Лебединская Е.В., Миронов А.Н., Меркулов В.А. ПЕРСПЕКТИВНЫЕ МЕТОДИЧЕСКИЕ ПОДХОДЫ К ДОКЛИНИЧЕСКОМУ ИССЛЕДОВАНИЮ БИОМЕДИЦИНСКИХ КЛЕТОЧНЫХ ПРОДУКТОВ И ВОЗМОЖНЫЕ ПОКАЗАТЕЛИ ИХ КАЧЕСТВА // БИОпрепараты. Профилактика, диагностика, лечение. 2015. №1  – in Russian методические подходы к ДКИ(53).