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Ustekinumab is a monoclonal antibody drug that is used to treat various autoimmune diseases such as Crohn's disease, ulcerative colitis, and psoriasis.
The drug is manufactured by Janssen Biotech, Inc.
, a subsidiary of Johnson & Johnson, and was approved by the U.
S.
Food and Drug Administration (FDA) in 2016.
The synthetic route of ustekinumab involves the use of recombinant DNA technology and protein engineering techniques to produce the monoclonal antibody.
The process involves several steps, including the expression of the heavy and light chains of the antibody in a host cell, purification of the expressed protein, and modification of the protein to enhance its stability and efficacy.
The first step in the synthetic route of ustekinumab is the construction of the gene that encodes the monoclonal antibody.
This is done through the use of recombinant DNA technology, which involves the manipulation of genetic material to produce a specific genetic sequence.
The gene is then inserted into a host cell, such as a Chinese hamster ovary (CHO) cell, where it is expressed as a protein.
The next step is the expression of the heavy and light chains of the antibody in the host cell.
This is done by transfecting the host cell with the gene and then culturing the cell in a nutrient medium that contains the necessary components for the cell to express the protein.
The host cell is then harvested and the expressed protein is purified from the cell culture supernatant.
The purified protein is then modified to enhance its stability and efficacy.
This is done through the use of protein engineering techniques, such as the addition of specific modifications to the protein structure, such as the use of flexible linkers to enhance the stability of the protein.
The final step in the synthetic route of ustekinumab is the formulation of the drug.
This involves the mixing of the purified, modified protein with other components, such as a buffer and a preservative, to produce a final form of the drug that is ready for use.
Ustekinumab is synthesized using advanced technologies and techniques that enable the production of a highly pure and effective drug.
The drug's synthetic route is a testament to the power of recombinant DNA technology and protein engineering in the development of new drugs and treatments for a variety of diseases.
In conclusion, the synthetic route of ustekinumab involves the use of recombinant DNA technology and protein engineering techniques to produce a highly effective and purified monoclonal antibody drug.
The drug represents an important treatment option for patients suffering from autoimmune diseases, and its synthetic route highlights the advancements in biotechnology that are driving the development of new drugs and treatments for a variety of diseases.
The synthetic route of ustekinumab is an important milestone in the fight against autoimmune diseases and is a testament to the power of biotechnology in improving human health.