Cumulative updating approved biopharmaceuticals

This has generated specific strains of many microbial species adapted to protein production, and has allowed the progressive incorporation of yeasts and eukaryotic systems for this purpose.Therefore, many human proteins have an important pharmaceutical value but they are difficult to obtain from their natural sources.Recombinant DNA (r DNA) technologies, developed in the late 70's using the bacterium as a biological framework, offer a very potent set of technical platforms for the controlled and scalable production of polypeptides of interest by relatively inexpensive procedures.The versatility and scaling-up possibilities of the recombinant protein production opened up new commercial opportunities for pharmaceutical companies.Since the approval of recombinant insulin, other recombinant DNA drugs have been marketed in parallel with the development and improvement of several heterologous protein production systems.This fact indicates that despite the diverse bottlenecks and obstacles that microbial systems pose to the efficient production of functional mammalian proteins, namely lack or unconventional post-translational modifications, proteolytic instability, poor solubility and activation of cell stress responses, among others, they represent convenient and powerful tools for recombinant protein production.The entering into the market of a progressively increasing number of protein drugs produced in non-microbial systems has not impaired the development of products obtained in microbial cells, proving the robustness of the microbial set of cellular systems (so far ) developed for protein drug production.Therefore, deficiencies in the production of specific polypeptides or the synthesis of mutant, non-functional versions of biologically relevant protein usually derive in pathologies that can range from mild to severe.

We summarize here the nature, properties and applications of all those pharmaceuticals and the relevant features of the current and potential producing hosts, in a comparative way.Proteins are catalysers of metabolic reactions, structural components of biological assemblies, and responsible for inter and intracellular interactions and cell signalling events that are critical for life.Monoclonal antibodies continue their march on the markets, optimized so-called biobetter versions of existing biologics are also gaining ground, but the rate of biosimilar approvals has seen a dramatic slowdown in recent years.Most of the hosts used to produce the 151 recombinant pharmaceuticals so far approved for human use by the Food and Drug Administration (FDA) and/or by the European Medicines Agency (EMEA) are microbial cells, either bacteria or yeast.This can be done in convenient microbial cells such as bacteria and yeasts, whose cultivation can be accomplished by relatively simple procedures and instrumentation.

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In early 80's, the FDA approved the clinical use of recombinant human insulin from recombinant ], being the first recombinant pharmaceutical to enter the market.

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