Detail of basic steps involved in synthesis of a recombinant drug product. Justify by manufacturing protocol of recombinant insulin.

Human Anatomy & Physiology (11th Edition)
11th Edition
ISBN:9780134580999
Author:Elaine N. Marieb, Katja N. Hoehn
Publisher:Elaine N. Marieb, Katja N. Hoehn
Chapter1: The Human Body: An Orientation
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Detail of basic steps involved in synthesis of a recombinant drug product.
Justify by manufacturing protocol of recombinant insulin.

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Step 1

The basic steps involved in the synthesis of a recombinant drug product are as follows: -

  1. Isolation of the genetic material (DNA must be free from other macromolecules like proteins, RNA or enzymes etc)
  2. Cutting of DNA at a specific location by restriction  enzymes
  3. Obtaining the required DNA fragment (agarose gel electrophoresis)
  4. Amplification of gene of interest by using Polymerase chain reaction (PCR)
  5. Ligation of DNA fragment into a vector requires a vector DNA, host DNA and a gene of interest
  6. Recombinant DNA is inserted into the host cell.
  7. obtaining or culturing the foreign product or recombinant products
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