Interleukin-2 (IL-2) is well known in the role of a cytokine involved in the treatment of cancers, especially the two epithelial kidney and skin cancers (melanoma). The main purpose of this research is to build up the standard technological process to produce human recombinant IL-2 in the Good-Manufacturing-Production (GMP) condition in Vietnam. To conduct this work, these methods had been used such as gene expression in Bioflo-110-NBS-USA fermenter system, recombinant protein extraction, recombinant protein purification using Bio wide pore C5 column (Supelco) on the Shimadzu HPLC system. All these works were conducted at the Factory of Vaccines and Biologicals production Company No.1 - VABIOTECH, Ministry of Health. Results: The recombinant IL2 was successfully produced in scale of 5 liters fermenter at the yield of 0.5 g/I. The crude recombinant IL-2 was extracted and further purified using HPLC system. The results showed that the purified recombinant IL-2 was yielded at the concentration of 0.5 mg/ml with more than 98 percent of purity. The biological activity of IL-2 product was approximately 300,000 IU/dose. Moreover, the concentration of residual pyrogen was less than 10 EU/ml which met the standards set. Conclusion: Success in the building up the standard recombinant IL-2 production process in the Good - Manufacturing - Production (GMP) condition in Vietnam.
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