Recombinant DNA Technology

Abstract

Recombinant DNA or rDNA technology refers to the creation of a hybrid or chimeric DNA by inserting a foreign sequence into the DNA of another species. It starts with extracting the gene of interest by using an appropriate restriction endonuclease enzyme and incorporating this gene into a suitable self-replicating vector such as a plasmid. This is made possible by cleaving the vector’s DNA using the same restriction endonuclease and sealing it back using DNA ligase. Finally, the vector is inserted into the host such as E. coli or Saccharomyces cerevisiae. Now the plasmid will multiply and the translation machinery of the E. coli will synthesize proteins from this plasmid. rDNA technology has been used to synthesize hormones, vaccines, drugs like alpha-interferon, and genetically modified food, and in gene therapy. Two similarly manufactured recombinant DNA technology products are termed biosimilars as opposed to generic drugs. In 2012, the draft guidelines were launched on “Similar Biologics: Regulatory Requirements for Marketing Authorization in India.”