"Biotechnology," or "biotech" for short, refers to the application of biological research techniques to develop products and processes using biological systems, living organisms, or derivatives of organisms. Biotech processes have been used for thousands of years, yet the industry we know today is scarcely more than a quarter century old. Bread, cheese and beer - all products made from microorganisms - have been part of the human diet for 6,000 years. But it was not until the 1970s that scientists began to apply components of these microorganisms at the molecular level to solve human problems in spheres ranging from medicine to agriculture and industry. Due to this breadth of applications, the term "biotechnology" gradually gave way to the more accurate "biotechnologies" or a collection of techniques that apply cellular and molecular characteristics and processes to solve human problems. Such techniques are applied at the molecular level and include genetic manipulation, gene transfer, DNA typing and cloning or microorganisms, plants and animals. Biotech products or "biologics" as they are sometimes called, thus originate from living organisms - bacteria, cells or animals.

History of biotech

The biotechnology industry has experienced phenomenal growth over the last 25 years. But its beginnings can be traced all the way back to 1750 B.C., when the Sumerians used yeast to brew beer. As early as 500 B.C., the Chinese used mold as an antibiotic. In the 1860s, the monk Gregor Mendel worked on gene transmission in plants, initiating the study of genetics.

An agricultural engineer coined the term "biotechnology" in 1919. In 1928, penicillin was discovered. In 1941, George Beadle and Edward Tatum posited the "one gene, one enzyme" theory, which held that genes are coded instructions for building proteins. In 1944, Oswald Avery found that the molecule, DNA or deoxyribonucleic acid, was the molecule that contained genes. In 1953, working at Cambridge University in England, James Watson and Francis Crick discovered the helix-like structure of DNA.

The following two decades - from 1960 to 1980 - saw a rapid acceleration in knowledge. The first synthetic antibiotic was available in 1960. The first mouse-human cells were fused in 1965. In 1967, Marshall Nirenberg and Har Gobind Khorana cracked the genetic code. By the 1970s, methods to cut and paste genes were developed. By 1981, the first transgenic animals were bred.

By 1983, the first artificial chromosome was made followed rapidly by genetically engineered plants in 1985, the use of microbes to clean up environmental pollution (oil spills) in 1986, and the first patent for a genetically altered animal in 1988. In the 1990s, the first non-viral full gene sequence was completed in 1995, followed by the unveiling of the cloned sheep "Dolly" in 1997, and the near completion of mapping of the human genome in 2002.

This dizzying acceleration of knowledge has created a burgeoning industry with an increasing number of commercial products, which, despite the recently past stock market downturn, is poised to undergo significant growth in the remainder of the decade and onward in the 21st Century.

Departments in a biotech company

Biotech companies focused on healthcare applications contain all the major departments of conventional pharmaceutical companies - R&D, operations, quality, clinical research, business development and finance and administration. In fact, the top 10 biotech companies are essentially mid-cap pharmaceutical companies. Each department houses several functional groups, or specific, logically related areas of activity. The three charts below illustrate how departments and functional groups are organized in different size companies.

As you think about a career in the biotech industry, it is useful to identify the general area(s) where your primary interests and aptitudes lie. Let's take a closer look at how functional groups are organized in different departments.

Research and development

The research and development (R&D) department is responsible for discovering promising drug candidates. The three major functions include discovery research, bioinformatics, and animal sciences. The discovery research function is responsible for performing experiments that identify either targets on the cell or potential drug candidates. The animal sciences function provides cell cultures, grows microorganisms and manages the care of animals used in discovery research. The extensive data generated from experiments is analyzed with the assistance of the bioinformatics function, which assists discovery research in identifying the most biologically active compounds.

Operations

The operations department is responsible for making commercial quantities of a candidate drug available. Once a promising drug candidate has been identified, the process/product development function determines how to "scale up" quantities of a product to make enough available for clinical trials, since laboratory-size quantities are usually very small. When a product emerges from clinical trials successfully, the manufacturing and production function creates the final product - complete with packaging and labeling - that we see on pharmacist and drugstore shelves. Also housed under the operations umbrella is the environmental health and safety function, which assesses the environmental impact of a potential product.

Clinical research

Once a drug candidate emerges from R&D, the clinical research department takes over and becomes responsible for shepherding the drug through the FDA approval process. The clinical research function sets up and manages the clinical trials needed to determine a drug's safety and effectiveness or "efficacy." The regulatory affairs function ensures that all FDA reporting requirements are completed and submitted in a timely manner. Finally, the medical affairs/drug information function is responsible for overseeing all the information related to a drug candidate.

Quality

The quality department has groups focusing on quality control, quality assurance, and validation. These groups ensure that products are manufactured along rigorous, consistent standards of quality. This usually entails that well-defined and documented procedures are followed when producing a product either for clinical trials or as an end product.

Finance and administration

The finance and administration department contains these two functional areas as well as information systems and legal. All activities relating to the financial management of the company, its legal relationships to investors, creditors, and employees are housed in this department. The company-wide computer systems - separate from computing specifically directed at analyzing research data - are also managed here.

Business development

The business development group is typically responsible for identifying prospective new alliance partners and managing existing alliances. The marketing function studies markets, identifies target customer bases and sets pricing and promotion strategy. The Sales function actually meets with potential customers in the field - usually specialist physicians in targeted areas of specialization (e.g., cardiologists, endocrinologists, urologists, etc.)