Process For Producing Human Interferon Alpha By Synthetic Gene In E.Coli For Human Use

Abstract: The present invention relates to the synthesis of polypeptide from genetically modified Escherichia coli preferably Escherichia coliG_2bS.n having interferon activity comprising of an amino acid sequence corresponding to the amino acid sequence of human interferon alpha 2b protein, and having an extra amino acid methionine at the N-terminus. The recombinant expression system as inducible production system, comprising of: The recombinant E. coli having at least one or more copies of circular, extra chromosomal, self replicating, recombinant construct, which is self maintaining at more or less constant copy numbers during cell division. The recombinant expression construct has a novel synthetic DNA sequence that codes for such a polypeptide, a synthetic promoter or T7 phage promoter and such a gene or DNA. It further relates to the use of E. coli as a host organism that carries such recombinant expression vector to produce polypeptide in fed batch or batch mode of fermentation process. It also discloses: a novel process where in the peptide is produced intracellularly using an inexpensive inducer preferably sodium chloride, the composition of the unique media and process of fermentation to yield high biomass and the said protein up to 2.0 to 3.0 gram per liter, a novel process for isolation of the said peptide to homogeneity which has 45-50% recovery from the lysed E. coli cells in properly folded state and the stable formulation of this purified product for therapeutic use in human.

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