About Biotechnology
In 1919, Karl Ereky created the term “biotechnology” to describe the interaction of biology with human technology. Today, the modern use of the term applies to an industry that uses knowledge of organisms and biological systems, and the ability to manipulate these systems at a molecular level, to create, develop and market new techniques and products.
Biotechnology is an industry based on biology – the study of living things. Using what is known about biological systems, we integrate and apply knowledge from other science and math disciplines to create and develop techniques and products. These disciplines include chemistry, biochemistry, physiology, engineering, physics and computer technology. Biotechnology began 30 years ago and since that time has grown into a world-wide industry. Since many pharmaceutical companies now apply the same techniques utilized by biotechnology companies, the term “life science” is used to describe both industries.
Here are a few terms to help guide you through the biotechnology landscape.
Agricultural Biotech Sector: For thousands of years, farmers have used “selective breeding” to enhance preferred traits in animals and plants. Now, genetically modified organisms (GMO’s) are created through the introduction of desired traits via genetic engineering. Desired traits may include increased nutritional value, faster growth, higher yields, and disease and pest resistance. Plants and animals may also be modified to produce human therapeutics.
Biodefense Sector: The creation of biomedical detection systems and countermeasures will enhance our nation’s preparedness to respond to biological, chemical, radiological and nuclear threats.
Biologics: Products derived from living sources as opposed to a chemical process. Biological products include bacterial and viral vaccines, human blood products, skin grown for burn victims, and gene therapy.
Bioinformatics: The storage and analysis of the vast amounts of information generated by the industry.
Biosensors: Devices that translate biological variables such as movement, chemical concentrations, etc. into electrical signals. These devices could be miniaturized and used to internally monitor biological systems. Also used in biodefense as detection systems
Combinations: These consist of two or more regulated components: drug/device, drug/biologic, biologic/device, or drug/biologic/device. Each is produced as a single product. Combinations include surgical mesh with antibiotic coating, a spinal fusion device with a genetically engineered human protein, dermal collagen implants, intranasal mist delivery system for vaccines, and a glucose monitor/insulin pump combination.
Devices: include pacemakers, cochlear implants, catheters, contact lenses, prostheses, hearing aids, and more.
Diagnostics: The use of testing equipment and techniques including micro arrays and test kits (HIV, pregnancy, drugs and genetic). Genetic testing aids in the early diagnosis of disease and possible prevention.
Discovery and Testing Process: In the United States, the development and production of drugs, biologics, devices and combinations are regulated by the FDA. Regulations are stringent and will vary based on the product. Below is a general overview of the steps for approval of a drug. Devices and combination products follow a similar process.
Drug Development: The process of drug research and development (R&D) is conducted in a laboratory. It begins with an idea and a search for candidates. These are molecules (chemicals or biologics) that are potential drugs. After a series of tests and data analysis, a lead candidate is selected and a patent application is filed. Preclinical trials test the lead candidate for toxicity and effectiveness on cells and animals. Prior to beginning clinical trials in humans, an IND (Investigational New Drug) application is filed with the FDA. With approval and specific guidelines, clinical trials begin. Once through clinical trials I, II and III, an NDA (New Drug Application) or BLA (Biologic License Application) is submitted. After favorable review of the data by the FDA, the drug is granted approval. Production of the drug takes place in a manufacturing facility according to FDA guidelines. Marketing and sale of the product proceeds until the patent expires. Patents protect products for 20 years from the date that the patent was filed.
Forensics: Using science to decide questions arising from crime or litigation. DNA fingerprinting can be used to solve crimes, determine paternity, and identify evolutionary relationships.
The Food And Drug Administration: From the FDA website (www.fda.gov): “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public receive the accurate, science-based information they need to use medicines and foods to improve their health.”
Industrial & Environmental Biotech Sector: This sector uses living organisms to manufacture a variety of products that result in the reduction of pollution, resource consumption and waste. Silk worms have been engineered to produce human collagen. Products include bioethanol, industrial enzymes, biological fuel cells, enzymes for bioremediation, biodegradable plastics and much more. Wood pulp is the by-product of paper production. Conventional methods of reducing the pulp use heat and chemicals. The use of fungi to break down the wood cellulose could result in an energy savings of 30%, and a cleaner environment.
The International Organization for Standardization (Iso): The ISO is a global, non-governmental agency. Created in 1947, it is a network of national standards institutes of 148 countries. ISO strives to create international, state-of-the-industry standardization for the approval and production of biotech products.
Nanotechnology: The manipulation of individual atoms and molecules to build structures at the nanometer level (10-9 m). R&D analysis, drug delivery, clinical diagnosis and pathogen detection are some of the main areas of focus.
Research Tools: Research tools support discovery and development of technologies used in biotechnology endeavors. Tools that have revolutionized the industry are gel electrophoresis, thermo cyclers, DNA and protein sequencers and microarrays. Research tools may also include the production of media to support cell growth, plasmids for use in genetic engineering, and the synthesis of DNA and protein molecules.
Regulatory Affairs: Clinical trials are developed and conducted by a group of regulatory affairs professionals (raps.org) who are familiar with FDA guidelines but are not employed by the FDA. Larger companies may have these professionals on staff while smaller companies will hire a clinical research organization (CRO) to provide the team. Clinical Research Associates (CRAs) set-up, monitor and complete clinical trials.
Therapeutics: There are currently 1,238 FDA approved vaccines and therapeutics on the market and over 738 in clinical trials from California alone. Pharmaceuticals include prescription, generic and over-the-counter treatments.
Vaccines: Protection against viral and bacterial agents.
This section is provided by BioTech Primer, Inc.
