Development of a new type of drug by using cell technology; preparation of human interferon-beta from human diploid fibroblast cultures.

Several strains of human fibroblast were identified as good producers of human interferon-beta (HuIFN-beta), among DIP-2 cell was one of the best. We have developed an improved microcarrier culture system for both the mass culture of such cells and the large scale HuIFN-beta production. A routine pilot plant, and successively a large plant, have been accomplished for preparation, purification and preclinical or clinical trials of HuIFN-beta. The purified and lyophilized HuIFN-beta was assayed for its safety for clinical use under the regulation of the National Institute of Health of Japan. Using this HuIFN- preparation, the clinical trials on various viral diseases and malignant tumors were started from the middle of 1979. More recently, the Ministry of Health and Welfare approved this HuIFN-beta as a new drug against melanoma, glioblastoma and chronic active B type hepatitis.