Disposable bioreactors: maturation into pharmaceutical glycoprotein manufacturing.
Modern biopharmaceutical development is characterised by deep understanding of the structure activity relationship of biological drugs. Therefore, the production process has to be tailored more to the product requirements than to the existing equipment in a certain facility. In addition, the major challenges for the industry are to lower the high production costs of biologics and to shorten the overall development time. The flexibility for providing different modes of operation using disposable bioreactors in the same facility can fulfil these demands and support tailor-made processes.Over the last 10 years, a huge and still increasing number of disposable bioreactors have entered the market. Bioreactor volumes of up to 2,000 L can be handled by using disposable bag systems. Each individual technology has been made available for different purposes up to the GMP compliant production of therapeutic drugs, even for market supply. This chapter summarises disposable technology development over the last decade by comparing the different technologies and showing trends and concepts for the future.
Brecht
René
R
ProBioGen AG, Goethestrasse 54, Berlin, Germany. rene.brecht@probiogen.de
D000911:Antibodies, Monoclonal / Q000096:biosynthesis; D001688:Biological Products / Q000378:metabolism / Q000592:standards*; D018070:Biological Specimen Banks / Q000592:standards; D019149:Bioreactors; D004209:Disposable Equipment; D004345:Drug Industry / Q000191:economics / Q000295:instrumentation* / Q000639:trends; D004867:Equipment Design; D004921:Erythropoietin / Q000096:biosynthesis / Q000592:standards; D006023:Glycoproteins / Q000096:biosynthesis / Q000592:standards*; D006801:Humans
D000911:Antibodies, Monoclonal; D001688:Biological Products; D006023:Glycoproteins; D004921:Erythropoietin; C101315:Capromab Pendetide