JOBS IN INDUSTRIAL BIOTECHNOLOGY

Identifying the different types of companies within the biotechnology industry can be difficult. Some companies are created for the purpose of exploring biotechnology, while others use the process of biotechnology to manufacture pharmaceutical, agricultural, environmental and food products.

The types of biotechnology companies can be divided in several ways. The Biotechnology Industry Organization separates the industry into the following areas: therapeutic, human diagnostics, supplier, chemical-environmental, and agricultural. Other industry organizations have added thecategories of energy production, medical devices, biopharmaceutical, veterinary, and various combinations of these categories.

The human therapeutics and diagnostics sectors have, by far, the greatest amount of activity, involving 65 to 70 percent of the biotechnology companies in the United States. About 17 percent of the companies are engaged in producing equipment and supplies for bioscience Research and manufacturing.The following are examples of types of activities taking place in five segments of the biotechnology industry and a brief description of the stages of production for a typical product.Human Diagnostics: Companies are engaged in producing medical devices to test for genetic and infectious diseases.

Genetic diseases, such as Sickle-cell anemia, Cystic Fibrosis, and Alzheimer's disease, are those in which heredity plays a major role. Infectious diseases, like human immunodeficiency virus (HIV), hepatitis B, and influenza, are those which arecaused by person-to-person exposure to bacteria or a virus. Examples of diagnostic products are tests for blood screening for various diseases, materials and equipment used to analyze samples of blood and other bodily fluids, and tools to locate defective genes which cause hereditary diseases. Companies produce materials and pharmaceuticals to treat illnesses.

Therapeutic products include genetically engineered proteins used to lessen the effects of heart attacks and to slow or halt the growth of cancer cells of patients with leukemia. Several companies are developing vaccines to treat AIDS and the diseases that are associated with AIDS.Genetically engineered growth hormones are being used to treat dwarfism, and other genetically engineered materials are commonly used to treat anemia and organ transplant rejection. Other diseases which are being treated or prevented through biotechnology include other forms of cancer, diabetes, and hemophilia.

Animal scientists have developed methods for breeding and raising farm animals so that they can be more efficiently raisedresulting in lower production costs. Products of biotechnology include treatments and tests for farm animal diseases such as those found in cattle, sheep, and pigs. Vaccines have been developed to prevent diseases such as foot-and-mouth disease in cattle, tapeworm in sheep, and dozens of other types of bacterial infections and viruses found in animals throughout the world.

Companies are marketing products developed by scientists which detect food-borne microbes and toxins and test for chemical contamination. Genes have been developed to be added to food crops to provide natural protection against insect pests. Genetically engineered enzymes have been used in producing high fructose corn syrup which is used as a sweetener in a large number of prepared foods and beverages and in producing enzymes for making cheese. Scientists are also working on plants which are drought and frost resistant.Environmental: Bacteria have been developed to clean up oil spills and chemical leaks from storage tanks by rendering the toxic materials or hazardous substances harmless.

Experts have said that this area of biotechnology offers great promise. Bacteria are also used in cleaning waste water of harmful chemicals and in detoxifying or reducing industrial waste at its source.

A company's first steps in producing and marketinga new product involves the process of Research and development (R&D).During R&D, small scale experiments take place as scientists and laboratory staff work together to develop new products which offer promise. At thispoint in time, the number of staff is usually quite small. Typically, an R&Dteam would consist of scientists, Research associates, laboratory assistants and technicians. Because Research is the primary function of the organization, at this point, most lead scientists possess Ph.D.s while other Research associates and technical support staff have bachelor's and master's degrees.

Research and Development is a lengthy process (lasting as long as one year or more). Researchers concentrate on new discoveries, and scientists and technical staff engage in process development and the scaling up of production resources to conduct full-scale manufacturing.R&D uses far fewer workers than manufacturing. Where R&D employs highly educated scientists, engineers, and support personnel, manufacturing does not share the same educational requirements.Actual production begins at the R&D stage when small amounts of the product are needed for testing and various experiments, including human clinical trials. Production, at this point, includes cell culture and fermentation, where the desired cells and cell parts are grown; primary recovery where the product is captured for further processing; and the purification and packaging of the product into bulk form.

A company must then prove to the U.S. Food and Drug Administration (FDA) that its product is safe and effective. After receiving approval from the FDA, it may begin testing the drug in clinical trials. During this phase, production of the product takes place in a pilot plant or in an expanded section of the laboratory. Up to fifty people may be employed to operate this small manufacturing facility and to conduct clinical Research.Before receiving FDA approval for manufacturing and marketing, a company must establish that its product is safe and effective and can be manufactured consistently, and the production processes adheres to FDA and U.S. Environmental Protection Agency (EPA) regulations relating to Good Manufacturing Practices (GMPs).As many as fifteen years may pass from the time a product is first conceived, developed, and tested before it finally receives regulatory approval from the FDA for manufacturing.

Upon receiving permission from the FDA, the manufacturing process is expanded to produce large quantities of product which may include creating a manufacturing facility. Additional staff are hired for the manufacturing process including technicians, operators of production and packaging equipment, quality systems personnel, and workers involved with product distribution.At this stage of operation, the company is hiring more technical personnel with bachelor's and master's degrees and fewer with Ph.D.s. At the time employment opportunities increase for technicians who have associate's degrees from community colleges as well as for support staff with high school diplomas.