RECOMBINANT THERAPEUTIC PROTEINS: SPECIALTY OF OBTAINING, SAFETY AND EFFECTIVENESS STUDY (review)

  • Ya. O. Nechaeva National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”
  • S. N. Grabchuk National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”
  • Yu. V. Gorshunov National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”
  • V. V. Motronenko National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”
  • A. Yu. Galkin National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”
Keywords: recombinant proteins, classification, therapy, biotechnology, safety, efficacy

Abstract

Recombinant proteins are extremely important for the therapy and diagnosis of many human and animal diseases. Medicines based on recombinant proteins have a number of features associated with the technology of obtaining, safety and effectiveness studies. In the review article, possible approaches to the classification of medical preparations based on therapeutic recombinant proteins were analyzed. First of all it was viewed biological (biotechnological) preparations within the framework of the international anatomical-therapeutic-chemical (ATC) classifier. According to the authors ATC classification is not always suitable for analysis of the market of biotech drugs as well as formation of prospects of biopharmaceutics. Alternative approach based on functions and medical application of biotech drugs (Group I: therapeutic proteins with enzymatic or regulatory activity; Group II: therapeutic proteins with special targeting activity; Group III: therapeutic proteins as vaccines; Group IV: therapeutic proteins as diagnostics).

A comparative analysis of different systems of expression of recombinant proteins was made (according to the following criteria: producer, vector, regulatory sequence, marker gene, technological and biomedical advantages and disadvantages). In particular, expression systems based on prokaryotic (bacterial cells) and eukaryotic organisms (yeast cells, insect cells, mammalian and plant cells) are considered. Expression systems based on bacterial cells are cost-effective and fast way to get many proteins. E. coli is the most detailed studied biological agent compared to others; it characterized by high yields of the target protein. But mostly target protein produced in the form of inclusion bodies in the randomly-expanded form (it requiring additional technological steps. Expression systems based on yeast cells are convenient because proteins are synthesized in secreted form. The target protein is synthesized as a glycosylated form, but the type of glycosylation does not always correspond to human. Expression systems based on insect cells provide a synthesis of secreted form of proteins. Disadvantages are expensive culturing mediums, and significant duration of biosynthesis process. Expression systems based on mammalian cells have following advantages: the target protein is humanized; high level of purity of proteins.

A short marketing characteristic of the world market of biologics was carried out. Particular attention is paid to modern international and domestic requirements for the study of the safety and efficacy of biological (biotechnological) origin products, including recombinant proteins. Quality, safety and efficacy of recombinant products are largely dependent on adequate control of raw materials and production process, as well as active pharmaceutical ingredient and of drug. Validation of cleaning processes for the removal / inactivation of undesirable materials (particularly viral contaminants, proteins and host cell DNA) are very important.

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How to Cite
Nechaeva, Y. O., Grabchuk, S. N., Gorshunov, Y. V., Motronenko, V. V., & Galkin, A. Y. (1). RECOMBINANT THERAPEUTIC PROTEINS: SPECIALTY OF OBTAINING, SAFETY AND EFFECTIVENESS STUDY (review). Bulletin of Zaporizhzhia National University. Biological Sciences, (2), 85-93. Retrieved from http://journalsofznu.zp.ua/index.php/biology/article/view/100