Common technological processes used in manufacture of biomedical cell culture products

Developing specific, effective and safe biomedical cell culture products (BCCP) assumes the following standard operating procedures: a) developing cell line with specific cell composition; b) obtaining a sufficient amount of cells of a specific cell line for therapeutic use as a part of BCCP; c) quality control and standardization of the developed cell line. Experts believe mesenchymal stromal cells (MSC) to be the first choice for the purpose of stem cell therapy. The development of a cell line with a specific cellular composition includes five sequential steps: selection of donors, sampling of biological material, cell isolation from donor material, preparation of standardized homogeneous population of cells, characterization of cell line composition of the cell line and its certification. The process of obtaining a sufficient amount of cells of a specific cell line for therapeutic use as a part of BCCP includes the selection of culture medium for cultivation of MSC, in special bioreactors for cultivation and culture control parameters. Quality control and standardization of the developed cell line assumes the elaboration of general requirements for quality parameters, characterizing all cell lines; as well as specific requirements for the assessment of therapeutic preparations in accordance with their proposed indications (for example, for the treatment of diabetes, bone grafting, restoration of blood supply to ischemic myocardium). The article describes typical procedures and identifies possible checkpoints for common technological methods used in BCCP manufacture and their quality assessment. It also outlines the requirements for the content of documents submitted by BCCP developer to an official authority in marketing authorization dossier as well as the expert evaluation procedure.