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Future of Pharma Industry - Biotechnology

Future of Pharma Industry - Biotechnology

Biotechnology can be defined as the use of living systems and organisms to develop or make useful products, or "any technological application that uses biological systems, living organisms or derivatives in order to make or modify products or processes for specific use.  However, contrary to its name biotechnology is not a single technology. Rather it is a group of technologies that share two (common) characteristics; working with living cells and their molecules and having a wide range of practice uses that can improve our lives.

Traditional biotechnology has been practiced since the beginning of records history.  It has been used to enhance the agricultural production, to bake bread, brew alcoholic beverages, and breed food crops or domestic animals. Through early biotechnology, the earliest farmers selected and bred the best suited crops, having the highest yields, to produce enough food to support a growing population.

As crops and fields became increasingly large and difficult to maintain, it was discovered that specific organisms and their by-products could effectively fertilize, restore nitrogen, and control pests. Throughout the history of agriculture, farmers have inadvertently altered the genetics of their crops through introducing them to new environments and breeding them with other plants; it was one of the first forms of biotechnology.

Biotechnology has also led to the development of antibiotics. In 1928, Alexander Fleming discovered the mold Penicillium. His work led to the purification of the antibiotic by Howard Florey, Ernst Boris Chain and Norman Heatley, penicillin. In 1940, penicillin became available for medicinal use to treat bacterial infections in humans.  

The field of modern biotechnology is generally thought of as having been born in 1971 when Paul Berg's (Stanford) experiments in gene splicing had early success. The commercial viability of a biotechnology industry was significantly expanded on June 16, 1980, when the United States Supreme Court ruled that a genetically modified microorganism could be patented in the case of Diamond v. Chakrabarty.

Biotechnology in Pharmaceutical products

Biotechnology is being increasingly used in Drug production where biotechnical methods are now used to produce many proteins for pharmaceutical and other specialized purposes. A harmless strain of Escherichia coli bacteria, given a copy of the gene for human insulin, can make insulin. As these genetically modified (GM) bacterial cells age, they produce human insulin, which can be purified and used to treat diabetes in humans. Microorganisms can also be modified to produce digestive enzymes. In the future, these microorganisms could be colonized in the intestinal tract of persons with digestive enzyme insufficiencies.

Products of modern biotechnology include artificial blood vessels from collagen tubes coated with a layer of the anticoagulant heparin.

Biotechnology is also commonly associated with landmark breakthroughs in new medical therapies to treat hepatitis B, hepatitis C, cancers, arthritis, hemophilia, bone fractures, multiple sclerosis, and cardiovascular disorders. The biotechnology industry has also been instrumental in developing molecular diagnostic devices that can be used to define the target patient population for a given biopharmaceutical. Herceptin, for example, was the first drug approved for use with a matching diagnostic test and is used to treat breast cancer in women whose cancer cells express the protein HER2.

Biotechnology in Pharmacogenomics

Another important field where Biotechnology is being increasingly used is Pharmacogenomics. Pharmacogenomics is the study of how the genetic inheritance of an individual affects his/her body's response to drugs. It is compound derived from the root of the word "pharmacology" plus the word "genomics". It is hence the study of the relationship between pharmaceuticals and genetics. The vision of pharmacogenomics is to be able to design and produce drugs that are adapted to each person's genetic makeup.

Pharmacogenomics results in the development of tailor-made medicines. Using pharmacogenomics, pharmaceutical companies can create drugs based on the proteins, enzymes and RNA molecules that are associated with specific genes and diseases. These tailor-made drugs promise not only to maximize therapeutic effects but also to decrease damage to nearby healthy cells.

Through Pharmacogenomics more accurate methods of determining appropriate drug dosages is possible. Knowing a patient's genetics will enable doctors to determine how well his/ her body can process and metabolize a medicine. This will maximize the value of the medicine and decrease the likelihood of overdose.

Use of Pharmacogenomics has led to improvements in the drug discovery and approval process. The discovery of potential therapies will be made easier using genome targets. Genes have been associated with numerous diseases and disorders. With modern biotechnology, these genes can be used as targets for the development of effective new therapies, which could significantly shorten the drug discovery process.

Better vaccines and safer vaccines can be designed and produced by organisms transformed by means of genetic engineering. These vaccines will elicit the immune response without the attendant risks of infection. They will be inexpensive, stable, easy to store, and capable of being engineered to carry several strains of pathogen at once.

Biotechnology in Genetic testing

Genetic testing involves the direct examination of the DNA molecule itself. A scientist scans a patient's DNA sample for mutated sequences. Genetic testing is now used for:

  • Carrier screening, or the identification of unaffected individuals who carry one copy of a gene for a disease that requires two copies for the disease to manifest;
  • Confirmational diagnosis of symptomatic individuals;
  • Determining sex;
  • Forensic/identity testing;
  • Newborn screening;
  • Prenatal diagnostic screening;
  • Presymptomatic testing for estimating the risk of developing adult-onset cancers;
  • Presymptomatic testing for predicting adult-onset disorder.

Gene Therapy

Gene therapy involves the genetic engineering of a patient’s genetic code to remove or replace a mutant gene that is causing disease. There are two broad types of gene therapy that are possible. Germline, or stem-cell, gene therapy involves altering patients' DNA in their stem (reproductive) cells. The modification to their genetic “blueprint” is permanent, and hereditary. This type of gene therapy is complex, and is considered too risky to undertake until the underlying biology is better understood. It also raises many ethical concerns, for example, over the potential misuse of the therapy to create “designer” babies. At the moment, germ-line gene therapy is banned in many countries. The second type of therapy is somatic gene therapy. This involves engineering cells on a “localized” basis, without affecting the patient’s basic genetic blueprint.

INDIA as a HUB for Biotechnology

Following the phenomenal success of its information technology industry, India is fast emerging as an important player in the biotechnology sector in the Asia–Pacific Region. The large pool of scientific talent available at a reasonable cost, a wealth of R & D institutions, a rich and varied bio-diversity, a flourishing pharmaceutical industry, strong IT skills and an  English speaking population have all placed India favourably in the global market. Biotechnology is the new sunrise sector in India and is poised to take the country into the next big league of internal and international investment.

India is ranked among the top-12 biotech destinations in the world and is the third biggest in the Asia-Pacific region in terms of the number of biotech companies according to a report by the Confederation of Indian Industry (CII) and the consultancy firm KPMG.

India is becoming one of the most favoured destinations for collaborative R&D, bioinformatics, contract research and manufacturing and clinical research as a result of growing compliance with internationally harmonised standards such as Good Laboratory Practices (GLP), current Good Manufacturing Practice (cGMP) and Good Clinical Practices (GCP). A well-defined regulatory framework, along with an emerging stringent IPR regime is also contributing to this trend.

Top 25 Biotechnology companies in India

  • Serum Institute of India
  • Biocon
  • Panacea Biotech
  • Nuziveedu seeds
  • Rasi Seeds
  • Novo Nordisk
  • Novozymes South Asia
  • Indian Immunologicals
  • Mahyco
  • Syngene International
  • Jubilant
  • Shantha Biotech
  • Bharat Serum
  • Eli Lilly
  • Bharat Biotech
  • Themis Medicare
  • Aventis
  • Haffkine BioPharma
  • Rossari Biotech GSK
  • Ankur Seeds
  • Advanced Enzymes
  • Ocimum Biosolutions
  • Nath Seeds
  • Concord Biotech

 

Top 20 Pharmaceutical companies in India

 

 

  • Ranbaxy Laboratories Ltd
  • Astra Zeneca
  • Dr Reddy’s Laboratories
  • Cipla Ltd
  • Nicholas Piramal India Limited
  • Aurobindo Pharma Limited
  • GlaxoSmithKline Pharmaceuticals Ltd
  • Lupin Ltd
  • Sun Pharmaceuticals
  • Cadila Pharmaceuticals Ltd

 

  • Orchid Chemicals and Pharmaceuticals
  • Wockhardt Ltd
  • Nestor Pharma
  • Natco Pharma Limited
  • MSD Pharmaceuticals Pvt Ltd
  • Aventis Pharma Limited
  • Glenmark Pharmaceuticals Ltd
  • Pfizer Ltd
  • Torrent Pharmaceuticals Ltd
  • Nycomed Pharma Pvt. Ltd

 

Building awareness for Biotechnology

 

Some of the applications of biotechnology described earlier have potentially serious implications for socio-economic welfare, and ethical and moral well-being. If biotechnology is to be used to provide benefits to a country’s population, then political support, as well as public awareness and acceptance of new technologies are essential. There is a wide range of potential applications, and decisions have to be made concerning the choice of technologies, according to national needs.

The public has a constructive role to play in helping to make these choices, but in most countries, including industrialized countries; public awareness and knowledge about biotechnology are insufficient for ordinary people to have an effective and qualified voice in biotechnology development. Building public awareness and disseminating qualified and balanced information about biotechnology is a critical issue in most countries.

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