Biotechnology
Biotechnology is generally defined as the management of cells and tissues for human benefit. In modern contexts the term almost always implies genetic engineering or the use of genomics. As biotechnology is a process, not a product, its scope includes a wide range of other areas such as agriculture (e.g., transgenic plants) and industry (e.g., using enzymes to destroy toxins). The Alfred Mann Institutes, however, are focused on biotechnology with biomedical applications such as drug production, pharmacogenomics, gene therapy, and genetic testing.
A number of new drugs being developed today are made using emerging biotechnological methods such as genetically engineered microorganisms that are then able to cost-effectively and safely produce useful biological molecules. The creation of drugs similar to traditional pharmaceuticals is carefully regulated by the same processes as standard pharmaceuticals, under the US FDA. The creation of more complex biologics (enzymes, serums, etc.) are regulated by either the FDA’s Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER), depending on the biologic categorization. Biotechnology as an industry started in the 1970s when Stanley Cohen and Herbert Boyer proved that genes could be transferred into bacterial cells, which would then express those genes. This technique, called recombinant DNA, allows for the production of proteins under controlled conditions.
There are currently more than 200 new therapies, drugs, and vaccines in production as a result of biotechnology, and more than 400 currently in clinical trials. Of the 1400 biotechnology companies in the US, over 300 are publicly held and have a total market capitalization of $410 billion. Because of the small size of many of these companies, a number of them have partnered with pharmaceutical firms or other biotechnology companies to leverage each others’ resources.
Though biotechnology spans many treatments and uses, from producing insulin to diagnosing the blood supply for the AIDS virus, following are several applications of the technology:
Pharmacogenomics is the study of how genomics affects drug responses. Using the knowledge of how genes are associated with various diseases can lead to improvements in drug development, choosing which drugs to administer, and even dosages to most effectively treat patients. As this is a relatively new field, the FDA is still actively working on establishing appropriate regulations.
Gene therapy is an experimental technique that uses genes to treat or prevent disease. This technology is still in its infancy, and to date the FDA has not approved any gene therapy product for sale.
Genetic testing is the analysis of DNA samples for mutated sequences. If the components of a test kit are bundled and sold to a laboratory, they are classified as in vitro diagnostic devices, which are used in the diagnosis of disease or other conditions, in order to cure, mitigate, treat, or prevent disease or its sequel. These saleable test kits are subject to the same regulations as medical devices. If a lab develops a test in-house and does not market it, it is not subject to FDA regulations.
US Biotech Industry Statistics: 1994–2005 (amounts are US dollars in billions).