Abstract
Recombinant proteins are produced for various applications in laboratory and industrial settings. Among them, therapeutic applications have evolved into a mature field in recent years, affecting the face of contemporary medical treatment. This, in turn, has stimulated an ever-greater need for innovative technologies for the description, expression, and purification of recombinant protein biopharmaceuticals. Therefore, many biopharmaceuticals are synthesized in heterologous systems to obtain satisfactory yields that cannot be provided by natural sources. As more than 35 years has passed since the first recombinant biopharmaceutical (human insulin) successfully completed clinical trials in humans, we provide a brief review of the available prokaryotic and eukaryotic expression systems, listing the advantages and disadvantages of their use. Some examples of therapeutic proteins expressed in heterologous hosts are also provided. Moreover, technologies for the universal extraction of protein molecules are mentioned here, as is the methodology of their purification.
Highlights
Human cells produce an enormous number of proteins, and dysfunction in these may lead to serious diseases and developmental abnormalities
A well-known example of a therapeutic protein produced on an industrial scale in carrot cell cultures (ProCellEx6) is the human recombinant β-glucocerebrosidase enzyme used in the treatment of Gaucher disease [40]
Due to the fact that 2017 marked 35 years since the first recombinant medicine was approved by Food and Drug Administration (FDA), we provided a brief reminder of the available prokaryotic and eukaryotic expression systems and of variations of the “first-to-try,” most established method of purification: chromatography
Summary
Human cells produce an enormous number of proteins, and dysfunction in these may lead to serious diseases and developmental abnormalities To treat these protein deficiencies the missing or dysfunctional molecules are complemented or substituted with therapeutics provided by different biological systems. It is undoubtedly a challenging task to obtain an active protein in a way that is economically feasible, biopharmaceuticals (recombinant proteins, monoclonal antibodies, or vaccines) are the largest group of drugs developed in the pharmaceutical industry [3]. The more detailed characteristics of the expected value growth of particular biologic types in the biopharmaceuticals market (divided into dominating monoclonal antibody, growth and coagulation factor, interferon, vaccine, insulin, erythropoietin, and hormone) are available in the report and on the Allied Market Research website [5]. In the context of this review the term “recombinant protein biopharmaceuticals” includes any pharmaceutical protein drug (e.g., recombinant proteins and peptides, vaccines, and monoclonal antibodies) that was obtained via engineering of biological sources
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