Animal cell proteins in human diagnosis and therapy

Animal cell proteins in human diagnosis and therapy 

The first therapeutic antibody approved (Orthoclone OKT-3 or Muromonab CD3, 1986) was indicated not for cancer treatment, but for controlling acute rejection of transplanted organs (kidney, heart, and liver). Nowadays, other clinical indications such as asthma, rheumatoid arthritis, psoriasis, and Crohn s disease are treated with mAbs (see Chapter 17) (Antibody Engineering and Manufacture, 2005 Monoclonal Antibodies and Therapies, 2004 Hot Drugs, 2004 Walsh, 2004). 

Many recombinant proteins that are not antibodies are also on the market for distinct applications (see Chapter 16). Examples are factor VIII for hemophilia A treatment (Bayer, 1993, produced from BHK cells), erythropoietin as an anti-anemic agent (Amgen, 1989, produced from CHO cells) and /1-interferon for the treatment of multiple sclerosis (Biogen and Serono, 1996, produced from CHO cells). 

The value of therapeutic mAbs marketed in 2004 was above US 13 billion. At the same time, the market value for the many presentation forms of erythropoietin exceeded US 8 billion, and the global biopharmaceutical market surpassed US 50 billion. 

It is worth emphasizing that all biopharmaceuticals mentioned here are produced from mammalian cell culture. The protein production system based on insect cells known as BEVS (baculovirus expression vector system) is widely employed for the expression of a wide range of proteins, but, due to regulatory issues, biopharmaceuticals produced by insect cells are not yet in the market. However, some of them are being evaluated, 

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