Commercial
Enterprise

Introductory Text:
Biotechnology Is A Commercial Enterprise

An introduction to biotechnology as a commercial enterprise and to
the nature of biotechnology workplaces

What is Biotechnology?

Biotechnology can be defined as a collection of technologies that use living systems, or materials derived from living systems, to make products. By this definition, biotechnology is one of the oldest industries – for thousands of years humans have used organisms to make help make products such as wine, cheese, and bread. However, when people use the term “biotechnology”, they are usually referring not to bread and cheese production, but rather to the more dazzling products of “modern biotechnology”, such as cloned sheep, gene therapies, and DNA fingerprints.

Modern biotechnology is rooted in hundreds of years of basic biological research into the intricacies of living systems. In the early 1970s, Drs. Herbert Boyer and Stanley Cohen published the results of basic scientific research demonstrating that genetic information could be intentionally transferred from one organism to another. In 1976, venture capitalist (click here to learn more about venture capital) Robert A. Swanson and Dr. Boyer founded a company, Genentech Inc., to apply this genetic methodology to the production of commercial products. In 1977, Genentech Inc. reported production of the first human protein manufactured in bacteria, somatostatin, a hormone that has many effects in the body. Genentech is generally considered to be the first “modern” biotechnology company, but many others were quickly founded. There are now hundreds of biotechnology products such as: human growth hormone, used to treat dwarfism; Interferon α-2b, used to treat a variety of viral diseases and cancers; and Hepatitis B vaccine, used to immunize people against the Hepatitis B agent. Gene therapy is a promising application of biotechnology that involves replacing a gene that is missing, or correcting the function of a faulty gene, in order to cure an illness.

The medical/pharmaceutical industry is not the only one impacted by the methods of modern biotechnology. For example, farmers commonly plant crops that are genetically modified to be resistant to herbicides. Genetically modified microorganisms are sometimes used to detoxify contaminated soil or water. Crime investigators use DNA methods to link a suspect to a crime scene. Biotechnology is thus a collection of technologies that have profoundly impacted many human enterprises.

The Organization Of A Biotechnology Company

A. The Research and Development Unit

Biotechnology companies are places where scientific discoveries are transformed into commercial products. This transformation begins in the research and development, R & D, unit. R & D is the organizational unit that finds ideas for products, performs research and testing to see if the ideas are feasible, and develops promising ideas into actual products. Table 1 lists a variety of tasks performed by R&D.

B. The Production Unit

The production unit in a company is responsible for making products. The systems used for production in biotechnology companies are diverse. Manufacturing a product may involve growing bacteria in laboratory flasks and isolating products from the cultures. In other situations, manufacturing involves growing bacteria, or other types of cells, in fermenters that are several stories tall and using industrial-scale equipment to purify products from the cultures. Production may involve growing cells in petri dishes, cultivating crops in a field, maintaining laboratory animals or even farm animals. Thus, the details of production vary greatly from company to company. However, certain functions, Table 2, are generally the responsibility of the production team.

C. The Quality Control/Quality Assurance Unit

The quality control/assurance unit (QC/QA) in a company is responsible for ensuring the quality of the product. We define “quality control”, QC, as a subsection of QA chiefly responsible for monitoring processes and performing laboratory testing. “Quality assurance”, QA, refers to all the activities and people who work to ensure the final quality of products. Although the terminology varies, the goal of the quality team is to assure a quality product. (See for example, “The Case of the q.c. Unit” by Kenneth G. Chapman, Timothy J. Fields and Barbara C. Smith. Pharmaceutical Technology, pp. 74-79, Jan. 1996 for a discussion of terminology.) The responsibilities of the quality unit are summarized in Table 3. (Click here to explore quality in the biotechnology workplace.)

D. The "Life Cycle" Of A Biotechnolgy Company

Small, start-up biotechnology companies that are in the early stages of developing marketable products may be almost entirely devoted to R & D. As products are being developed, a single individual may play multiple roles. For example, the research scientists who develop a product may also initially produce and package it for sale and may also deal with quality assurance and regulatory issues. The same facilities and the same types of equipment may be used to perform research and to make products. Thus the distinction between R&D, production, and QC/QA may be blurred in a start-up company.

A start-up company in its early stages of development must not only create new products, but must also find ways to finance its growth when it has no products to sell. As it does so, a business culture begins to evolve. Assuming the company successfully develops a product(s), more employees are hired, some of them specializing only in production or quality assurance activities. The equipment and facilities used for production typically become larger and distinct from those used for product development. As this maturation of the company occurs, government regulations and standards may play an increasingly important role and the quality assurance unit grows to keep up with these changes

As a company matures, its “feeling” also changes. It is sometimes said that there are three cultures within a mature biotechnology company -- R&D, production, and QC/QA. The R&D people work in an atmosphere of change and unpredictability. They often do not know which ideas will result in a product, which methods will work best, and how much success they will have in their endeavors. Creativity and a willingness to work with uncertainty characterize most investigators in R&D and in academic research laboratories. In production situations, attention to detail is critical and deviations from established procedures must be carefully considered and approved. The production team therefore works in a more predictable environment. The quality team is intent on assuring product integrity. The quality team interacts closely with outside agents, such as auditors, inspectors, and customers, and also works closely with the company’s R&D and production personnel. The quality assurance team must effectively manage problems and be conscious of the ramifications of particular courses of action.

E. Other Functions In A Company

There are other important areas in a biotechnology company including:

• Engineering (or facilities management), which is responsible for ensuring that the systems that control the building environment are operating properly and that large equipment is properly installed and functioning.
• Facility maintenance and housekeeping, which performs critical day to day functions, such as cleaning and certain building repairs.
• Receiving and shipping, which assures that incoming raw materials are properly routed and that products go to the proper destination.
• Dispensing, which puts products that are produced in bulk into individual containers for consumer use.
• Metrology, which ensures that instruments (such as those used in laboratories and those used to monitor production conditions) operate properly.
• Marketing and sales, which is responsible for interacting with customers.

THE Biotechnology Workplace

A. Biotechnology Laboratory Work Places

Let’s consider biotechnology laboratory workplaces in more detail. A laboratory is a place where people produce knowledge, data, or information. While people in laboratories produce tangible products such as photographs, antibodies, purified proteins, and printouts, these materials are produced with the purpose of learning more about a system or a sample, answering a research question, or documenting a discovery.

Small biotechnology companies often produce products in facilities that are also used for research or that are similar to research laboratories. However, we call any facility used for producing a commercial product a production facility, rather than a laboratory.

A research laboratory is one kind of laboratory. It is a space set aside to study the complexities of nature in a controlled manner. Experiments can be performed in a research laboratory in which the researcher controls the factors of interest. Universities house many of the research laboratories in which are made seminal discoveries that drive the biotechnology industry. So, the university biology research laboratory might be considered a biotechnology workplace. The methods used in research and development laboratories associated with biotechnology companies have much in common with university laboratories, but company R&D scientists are more focused on commercial applications of their work than are academic scientists.

A testing laboratory is another sort of laboratory environment. It is a place where analysts test samples. The product of a testing laboratory is a test result. A quality control laboratory is a type of testing laboratory where samples of products and raw materials are tested to see if they are of good quality. Once a biotechnology company begins to manufacture a product, it needs to create a QC laboratory and assign analysts to this important laboratory work.

Testing laboratories play a key role in biotechnology by testing the effects of drugs and other products that are in development. For example, before a drug can be marketed, it is tested in a multitude of ways in cells, in animals, and finally in human volunteers. Sometimes a biotechnology company does this testing in its own facilities. But, very often biotechnology companies do not perform all these tests themselves but rather contract with specialized testing companies to get their product tested. Thus, a testing laboratory is the workplace for many biotechnologists.

B. Biotechnology Workplaces Are Diverse

It is evident that there is not a single biotechnology workplace. For example, the work environment of an operator in a production facility is different than that of a person who works with documents in a quality assurance department or someone who works in the laboratory doing research and development tasks. The work of a production person in a start-up biotechnology company is different from that of an operator in a large production facility. Working in a company whose products are crop plants, is different than working in a company manufacturing drug tablets. Thus, a person entering biotechnology as a career will have many options and can find a place that suits their personality and interests. (Click here to learn about some biotechnologists and their workplaces.)

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