![]() ![]() 4 The importance of biopharmaceuticals and other biotechnology-based pharmaceuticals will evidently grow in the future as a significant part of all pharmaceutical candidates currently in clinical trials are developed or discovered by biotechnology companies. 3 In comparison, within the EU about 35% of all human pharmaceuticals approved for marketing since 1995 were biopharmaceuticals. 2 In 2002, biopharmaceuticals (and other biotechnologically manufactured pharmaceuticals) were estimated to represent nearly one quarter of all human pharmaceuticals for sale in the USA. 1 The markets are projected to reach $70 billion by the end of the decade. The global market for biopharmaceuticals (defined as recombinant therapeutic proteins and monoclonal antibody- or nucleic acid-based products used as therapeutics) was in 2004 valued at more than $44 billion. ![]() The use of recombinant proteins by research laboratories is also significant. Applications are, however, also found in, e.g., food, feed, and process industries, as well as in veterinary medicine. Among the different industries utilizing recombinant proteins, the economically most important ones are the pharmaceutical and diagnostics (nontherapeutic) industries. The market for recombinant proteins is growing rapidly. When aiming for industrial production, one has to consider a multitude of additional factors, such as the royalty burden of the host cell and vector, cost of raw materials, regulatory issues related to the host cell and vector (e.g., required containment level), harmful side-products (e.g., endotoxins), reproducibility, up-scalability, and ease of host cell contamination. Practical issues to consider include means of induction, need for posttranslational modifications and secretion signals, as well as protease activity of the host. There is, however, no universal expression host system that would work optimally for all proteins. The Escherichia coli bacterium is usually the starting point for any cloning and expression effort. When choosing an expression host for production of a specific recombinant protein, one can essentially select from a variety of different systems. © 2009 American Institute of Chemical Engineers Biotechnol. pastoris and Drosophila S2 systems were about two and 2.5 times higher than the respective costs of the E. When equal titers and bioreactor working volumes (10 L) were assumed for all three systems, the manufacturing costs of the bioreactor production of the P. pastoris and Drosophila S2 systems were about two and four times higher than the respective costs of the E. ![]() With different titers and production goal of 100 mg of Nef protein, the costs of P. pastoris) of the manufacturing costs, whereas with the Drosophila S2 system the cell line construction and bioreactor production phases were equally significant (46 and 47% of the total costs, respectively). When analyzing the cost impact of the different phases (strain/cell line construction, bioreactor production, and primary purification), we found that with the microbial host systems the strain construction phase was most significant generating 56% ( E. On scale of 100 mg protein, the labor costs corresponded to 52–83% of the manufacturing costs. Three popular expression host systems Escherichia coli, Pichia pastoris and Drosophila S2 were analyzed techno-economically using HIV-1 Nef protein as the model product. ![]()
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