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.
Kobayashi
S
S
Biomaterial Research Institute Co., Ltd., Yokohama, Japan.
D001709:Biotechnology; D002478:Cells, Cultured; D004171:Diploidy; D005347:Fibroblasts / Q000378:metabolism; D006801:Humans; D007370:Interferon Type I / Q000096:biosynthesis* / Q000302:isolation & purification / Q000592:standards; D011786:Quality Control
D007370:Interferon Type I