Sources of biopharmaceuticals

The bulk of biopharmaceuticals currently on the market are produced by genetic engineering using various recombinant expression systems. Although a wide range of potential protein production systems are available (Table 5.1), most of the recombinant proteins that have gained marketing approval to date are produced either in recombinant E. coli or in recombinant mammalian cell lines (Table 5.2). Such recombinant systems are invariably constructed by the introduction of a gene or cDNA coding for the protein of interest into a well-characterized strain of the chosen producer cell (Chapter 3). Examples include E. coli K12 and CHO strain K1 (CHO-K1). Each recombinant production system displays its own unique set of advantages and disadvantages, as described below.

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