1988 Volume 13 Issue 4 Pages 296-301
Several strains of human fibroblast were identified as good producers of human interferon-beta (HuIFN-β), amoung 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-β production. A routine pilot plant, and successively a large plant, have been accomplished for preparation, purification and preclinical or clinical trials of HuIFN-β. The purified and lyophilized HuIFN-β 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-β as a new drug against melanoma, glioblastoma and chronic active B type hepatitis.
