A biotech company or a pharmaceutical company researches, develops, and distribute drugs and medicines. Biotech companies must work under a variety of laws and regulations in order to test, market, and patent a particular drug.
The biotech industry is directly influenced by discoveries and inventions made around the world. Every single development in the medical and health care industries can leave an impression on the biotech companies. Generally, large and multinational biotech companies have the resources to patronize large scale drug discovery and developments along with manufacturing and doing quality control and marketing.
Smaller biotech companies, on the other hand, participate in developing formulations and discovering drug candidates.
Sometimes both the big scale and small scale biotech companies form joint ventures for a particular project.The drug discovery process is that of discovering potential drugs by using the modern biotechnological techniques.
Biotechnology research generally stresses understanding the metabolic pathways that are related to a disease, and then manipulating these pathways in order to find a solution to the problem.
When the suitability of a compound is established, the next stage in the process is the drug development by the biotech companies. In a country like the USA, all the new biotech or pharmaceutical products must be approved by the FDA.
The process of getting a certification from FDA involves the biotech company submitting the new drug by filing for Investigational New Drug (IND) with available pre-clinical data and then proceeding with human trials. After the IND certification, three phases of human clinical trials are conducted. In the first phase the toxicity of the medicine using healthy human volunteer is studied. Phase 2 includes dosing in patients, and the third phase is a large study of the efficacy in the patient population. To minimize the chances of causing any harmful side effects, the FDA conducts a fourth phase of testing known as post-approval observation. After giving the green light to a particular drug or medicine, the FDA publishes the entire information about the drug on the Orange Book site.
As biotech products directly affect the health of people, biotech companies have to follow certain regulations and rules in order to get a license for doing business. Whenever any pharmaceutical products showed adverse side effects, the concerned companies are in danger of being caught in a lawsuit.
Some of the major global biotech companies are:
Johnson & Johnson (USA)
Merck & Co. (USA)
Baxter International (USA)
Dr. Reddy’s Laboratories Ltd (India)
Last Updated on : 22th July 2013