Identification control for BMCP
Identification is one indicator of the quality of biomedical cell products. Product identification is a set of characteristics, specific indicators that distinguish a given product from others. (Read more about other quality measures in our article https://beawire.com/ru/2018/07/26/biomedical-cell-products-quality-indicators/). In the Russian Federation today there is no experience in carrying out an examination of the quality of BMCP, but the world experience in assessing the identification of cell lines included in cell therapy drugs (analogues of BMCP), is presented quite broadly.
It is worth starting with the fact that for every BMCP successfully passed preclinical study, the developer or manufacturer of BMCP, a specification is drawn up which is document containing information on the BMCP type (autologous, allogenic, combined), qualitative and quantitative composition, biological and other characteristics of the cell line (cell lines) and BMCP.
Identification is a qualitative indicator of the cell line.
According to E.V. Melnikova and co-authors one of the trends of determination of identification (identification of belonging of a particular cell line to a specific person) of cell lines that have spread in most recently, is the use of DNA fingerprinting technology, such as short tandem repeat analysis (STR).
According to the recommendations of the American Type Culture Collection Standards Development Organization Workgroup ASN-0002 (2010), American National Standardization Institute (2012), the STR technique is a benchmark of identification analysis of the cell line along with karyotype research. The world’s leading collections in specifications for the human cell line indicate karyotype characterization and STR-profile.
In general, a set of tests in determining the identity (authenticity) of BMCP shall provide a characterization of the cell line (s) in accordance with the requirements of pp. 11.1, 11.2. Specifications at BMCP, approved by the order of the Ministry of Health of Russia № 14n of January 19, 2017, namely, to define:
- Morphological characteristics of cell line (cell lines) (shape, size, degree of heterogeneity, features of cell growth, etc.);
- Expression of specific markers (surface markers: CD+, CD—);
- Expression of specific genes (in genetic modification or differentiation; for example, for genetically modified cells the used genetic constructions, features of their composition, methods of estimation of stability, description of the target gene responsible for therapeutic effect);
- Expression of specific proteins – own specific proteins or target proteins whose expression is due to modification associated with the therapeutic action of BMCP.
- Markers of cell line stability (karyotype formula, presence of structural and numerical chromosomal abnormalities; “DNA fingerprint”)
Thus, the determination of the “Identification” index of the cell component depends on the origin of the cell line and the presence of modification, with the phenotypic and genotypic cell profile.
- Melnikova E.V., Rachinskaya O.A., Trusov G.A., Khorolsky M.D., Semenova I.S., Tereshkina N.V., Merkulov V.A. Justification of Methodological Approaches to Identification Testing of Biomedical Cell Products. BIOpreparations. Prevention, Diagnosis, Treatment. 2019;19(1):28-38. (In Russ.)
- Order of the Ministry of Health of the Russian Federation of 08.08.2018 N 512n “On Approval of the Rules of Good Practice on Work with Biomedical Cell Products”
- Order of the Ministry of Health of the Russian Federation of 19.01.2017 N 14n (ed. 30.01.2019) “On approval of the specification form for biomedical cell product”