Biological Products

Drugs that are made using natural sources for the prevention or cure of disease are known as biological products. Recently the use of biological products has increased in pharmaceuticals. These can be large or complex molecules and are driven or specifically made using advanced techniques and processes. The use of biological products in pharmaceuticals can be traced back to history when vaccines were developed.

What are Biological Products?

Biological products are nothing but complex molecules that can be immunological products, hormones, steroids, antibodies, antitoxins, or even blood components. Generally, biological products are used in treatment when no other effective treatment for the disease is available.

Types of Biological Products

Following are the different types of biological products which are approved for the use 

• Therapeutic proteins: Insulin is a therapeutic protein which is used in patients who have diabetes.
• Monoclonal antibodies: Antibodies made from a single type of cells and recognise only one particular antigen are called monoclonal antibodies.
• Vaccines: These are weak or dead agents of disease, when administered to a healthy person, provide immunity to the particular disease. Several vaccines have been prepared for diseases like anthrax, rabies, cholera and hepatitis B. 
• Recombinant proteins: OKT-3 is used to prevent acute kidney transplantation rejection.ReoPro Is a recombinant protein which is used for the prevention of blood clots. Tissue Plasminogen activator protein is used for acute myocardial infarction as it dissolves blood clots.
• Gene therapy: The method of replacing a faulty gene with a normal healthy, functional gene is called gene therapy. It was first used to cure adenosine deaminase deficiency.
•  Interferons: Interferons are the chemical substances produced by cells when attacked by viruses. Interferons are also being tested to cure cancer and some viral diseases, including AIDS.
• Platelets: The platelet growth factor is used for healing wounds.
• Enzymes: Cystic fibrosis is cured by the DNase.

These biological products are either made using biotechnology or are simply driven from the body in which they are produced.

Let Us Understand How Several Biological Products are Made

Production of Insulin: Insulin is produced in the pancreas, and the gene responsible for its synthesis is located on chromosome 11. Insulin is produced as a prohormone in the body, and this is further processed and made mature by removing the C peptide to it. Tsan was the first to synthesise human insulin. A pharmaceutical company Eli Lilly prepared DNA sequences corresponding to A and B chains of human insulin and introduced them to plasmids of E.coli to produce insulin chains. Separate chains A and B were made and connected by a disulfide bond.

Gene Therapy: It can be of 2 types

1. In germline gene therapy, the germ cells are modified by adding functional genes into their genomes.
2. Somatic cell gene therapy uses somatic cells. At present only somatic cell gene therapy is allowed. The first clinical gene therapy was used to cure ADA deficiency. The deficiency of this enzyme can cause severe combined immune deficiency. In gene therapy, first, the lymphocytes are extracted from the bone marrow and are grown in a culture medium. A functional ADAc DNA is introduced in these cells and is again re-injected into the patient’s body.

However, a major drawback is that these cells die after a certain period, so this is not a permanent cure.

Vaccines: Edward Jenner gave this term. Vaccines are a great preventive measure against deadly diseases like Hepatitis B etc. Currently, the Coronavirus is also being prevented with the help of vaccines only. Several types of research are made to introduce edible vaccines. 

Monoclonal Antibodies: George Kohler and Cesar Milstein fused normal antibody-producing cells with cancerous cells to obtain monoclonal antibodies.

• First, a mouse is infected with a particular antigen which produces required antibodies. 
• The developed antibody is taken through its spleen, and the B lymphocytes are isolated. 
• On the other hand, cancer-causing cells are taken separately and are mixed with antibody-producing cells leading to hybridomas. 
• These hybridomas are multiplied and tested. The clones which produce the required antibody are taken to large scale production. 
• One of the most effective applications of monoclonal antibodies is immunosuppression for kidney transplantation.

Interferons

These are antiviral glycoproteins secreted by cells that get infected by a virus. Interferons serve as a barrier chemical that prevents other surrounding cells from getting infected by the virus. This property of interferon is highly useful in treating diseases caused by viruses. This chemical is produced in response to a chemical reaction occurring in the body.

1. IFN-a Is a kind of interferon produced when viruses attack leukocytes and lymphocytes.
2.  When fibroblasts, epithelial cells and leukocytes are infected by a virus, Interferon-b is produced.
3. Attack of the virus on  T lymphocytes leads to the production of interferon-g. 
4. Hepatitis b can be cured by using IFN-alpha interferons.

Quality Control of Biological Products 

Biological products like vaccines and antitoxin blood components are manufactured outside and supplied to the desired places with a district quality control environment, including temperature and sterility. A small amount of contamination can destroy the whole batch of products and cause a big loss in terms of money and health. Biological product quality control always ensures human life’s safety and has a positive effect on the company profile.

Conclusion

Biological products play an important role in pharmaceuticals. The production of biological products is different from the production of synthetic drugs. Recent advancements in biotechnology have led to the increasing usage of biological products to cure many diseases. Generally, diseases that are not cured by synthetic drugs are treated using these products. Some biological products can cure a disease permanently, while some treat the disease temporarily. When made in laboratories, biological products undergo a strict quality control check.