Question

In case of drugs, the formulation with suitable preservatives has to undergo_________ before its availability for commercial use.

• A. strict clinical trials
• B. accurate separation techniques
• C. heat shock treatment
• D. prolonged restriction digestion

Answer 1

The correct option is A strict clinical trials

Recombinant DNA technology uses techniques to alter the genome of a living organism for obtaining the product of interest. The host cell which is genetically engineered to carry a gene of interest is known as a recombinant cell. The gene of interest is transcribed and translated to produce the recombinant protein.

For commercialisation, large scale production is required which is achieved by culturing the cells in bioreactors. Once the concentration of the desired product in the culture medium reaches an optimal level, it needs to be extracted out.

Strict separation techniques are needed to isolate the gene product from the culture medium. This is followed by its purification to eliminate contaminants. Both are the components of downstream processing.

After the completion of downstream processing, the product is formulated with preservatives to increase the shelf life. If the desired product is a drug, this formulation with preservatives is then subjected to strict clinical trials in order to assess its efficacy, side effects, dosage etc. This is followed by quality control steps.

Heat shock treatment: By exposing cells to a high temperature, or heat shock, a pressure difference between the outside and the inside of the cell is created, that induces the formation of pores, through which plasmid DNA can enter.

Genomic DNA is subjected to restriction digestion (cutting DNA molecules into smaller pieces with special enzymes called restriction enzymes) for obtaining the gene of interest that has to be cloned.