Transgenic manufactured biopharmaceuticals: a new method of drug manufacturing

Abstract

The limit to product yield in biotechnology is reached at 500 - 800 mg/l fermentation broth. However, if large quantities of proteins are required for products which have to be marketed as quickly as possible, biotechnology remains the technology of choice. Challenging biotechnology, transgenic manufacturing processes use animals or plants with a productivity of up to 20 g/l. Whereas animal transgenic technology still risks potential contaminantion with prions, transgenic plants offer a rather safer manufacturing technology. Since glycosylation of the protein is specific to the production organism from the onset of product development, it must be decided whether the therapeutically active protein should be produced by mammalian cell culture, transgenic animal or transgenic plant. This, however, requires a decision on the manufacturing technology, prior to the knowledge of dose and potential market.

• drug safety
• mammalian cell culture
• therapeutically active proteins
• transgenic animals
• transgenic plants