Production and medical uses of interferon

The first recombinant interferon to become available for clinical studies was IFN-a2a, in 1980. Shortly afterwards the genes coding for additional IFN-as were cloned and expressed, allowing additional clinical studies. The antiviral, anti-tumour and immunomodulatory properties of these interferons assured their approval for a variety of medical uses. rhIFN-as manufactured/marketed by a number of companies (Table 8.8) are generally produced in E. coli. 

Clinical trials have shown the recombinant interferons to be effective in the treatment of various cancer types, with rhIFN-a2a and -a2b both approved for treatment of hairy cell leukaemia. This is a rare B-lymphocyte neoplasm for which few effective treatments were previously available. Administration of the recombinant interferons promotes significant regression of the cancer in up to 90 per cent of patients. 

Upstream processing (fermentation) and downstream processing (purification and formulation) are physically separated, by being undertaken in separate buildings. Fermentation is generally undertaken in specially designed 42 000 1 stainless steel vessels. After recovery of the product from the cells, a number of chromatographic purification steps are undertaken, essentially within 

Hairy cell leukaemia Renal cell carcinoma Basal cell carcinoma Malignant melanoma AIDS-related Kaposi s sarcoma Multiple myeloma Chronic myelogenous leukaemia Non-Hodgkin s lymphoma 

Mycosis fungoidesb Condyloma acuminata0 Chronic hepatitis B Hepatitis C Chronic hepatitis D 

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