title: Economic aspects of commercial manufacture of biopharmaceuticals.
abstract: Sustained approvals of new biopharmaceuticals supported by a sparkling pipeline are the drivers for the above-market growth of biopharmaceuticals. Due to usually high therapeutic dose of monoclonal antibodies, they are demanding for high capacity needs. This requires significant capital investment and stimulates innovation for process improvement to decrease cost of goods and to save capital investments. Such process improvements are either ongoing along the learning curve or result from significant process changes through regulatory authorities impact. Both approaches require extensive protein analytical guidance to maintain product quality, safety and equivalency. In addition to second generation processes, second generation products have the feature of optimizing the physiological principle of biopharmaceuticals to the therapeutic need and to decrease the therapeutic dose, which goes along with investment savings and lower cost of goods.
authors.affiliation: Boehringer Ingelheim GmbH, Corporate Division Biopharmaceuticals, Binger Strasse 173, 55216 Ingelheim/Rhine, Germany. rolf.werner@bc.boehringer-ingelheim.com
authors.forename: Rolf G
authors.initials: RG
authors.lastname: Werner
mesh_terms: D000595:Amino Acid Sequence; D000818:Animals; D000911:Antibodies, Monoclonal / Q000191:economics*; D001702:Biopharmaceutics / Q000191:economics*; D019149:Bioreactors / Q000191:economics*; D006801:Humans; D008969:Molecular Sequence Data; D011994:Recombinant Proteins / Q000737:chemistry / Q000191:economics; D010959:Tissue Plasminogen Activator / Q000737:chemistry / Q000191:economics
chemical_list: D000911:Antibodies, Monoclonal; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator; C068645:duteplase