Biopharmaceuticals current status and future prospects

Many of the initial biopharmaceuticals approved were simple replacement proteins (e.g. blood factors and human insulin). The ability to alter the amino acid sequence of a protein logically coupled to an increased understanding of the relationship between protein structure and function (Chapters 2 and 3) has facilitated the more recent introduction of several engineered therapeutic proteins (Table 1.3). Thus far, the vast majority of approved recombinant proteins have been produced in the bacterium E. coli, the yeast S. cerevisiae or in animal cell lines (most notably Chinese hamster ovary (CHO) cells or baby hamster kidney (BHK) cells. These production systems are discussed in Chapter 5. 

Although most biopharmaceuticals approved to date are intended for human use, a number of products destined for veterinary application have also come on the market. One early such example is that of recombinant bovine GH (Somatotrophin), which was approved in the USA in the early 1990s and used to increase milk yields from dairy cattle. Additional examples of approved veterinary biopharmaceuticals include a range of recombinant vaccines and an interferon-based product (Table 1.7). 

Product (Company) Product description (use) Annual sales value (US, billions) 

Remicade (Johnson Johnson) Monoclonal antibody based (treatment of Crohn s disease) 1.7 

Avonex (Biogen) Interferon-P (IFN-P treatment of multiple sclerosis) 1.2 

Many of the initial biopharmaceuticals approved were simple replacement proteins (e.g. blood factors and human insulin). The ability to logically alter the amino acid sequence of a protein, coupled to an increased understanding of the relationship between protein structure and function has facilitated the more recent introduction of several engineered therapeutic 

Genenteeh was founded in 1976 by scientist Herbert Boyer and the venture capitalist, Robert Swanson. Headquartered in San Francisco, it employs almost 5000 staff worldwide and has 10 protein-based products on the market. These include human growth hormones ( Nutropin , Chapter 8), the antibody-based products Herceptin and Rituxan (Chapter 10) and the thrombolytic agents Activase and TNKase (Chapter 9). The company also has 20 or so products in clinical trials. In 2001, it generated some US 2.2 billion in revenues, 24% of which it reinvested in R D. 

To date (mid-2002) no gene therapy based product has thus far been approved for general medical use (Chapter 11). Although gene therapy trials were initiated as far back as 1990, the 

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