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Biotech Industry Overview - History of Industry

LMSB-04-0207-019

"This document is not an official pronouncement of the law or the position of the Service and cannot be used, or cited, or relied upon as such."

2. History of Industry

The history of biotechnology begins when primitive humans became domesticated enough to breed plants and animals; gather and process herbs for medicine; make bread and wine and beer; create many fermented food products including yogurt, cheese, and various soy products; create septic systems to deal with their digestive and excretory waste products, and to create vaccines to immunize themselves against diseases. Archeologists keep discovering earlier examples of each of the uses of organisms by humans, but examples of most of these processes go back to between 5,000 and 10,000 BC.

It is evident that biotechnology in the past concentrated on the production of food and medicine and solving environmental problems.

Modern biotechnology, based on recombinant DNA technology, finds a similar distribution in the use of recombinant organisms to serve in the production of food, and medicines and solving environmental problems. Introducing genes into organisms, breeding organisms to form new variants, or treating organisms with specific compounds may accomplish this. Biomedicine is medicine based upon the principles of biology and biochemistry.

Biotechnology-derived products have the potential to positively change our society, from improving health care and increasing agricultural products to producing a cleaner environment.

Though a quarter of a century old, the industry remains relatively small compared to the traditional pharmaceutical industry, which bases its approach to drug development more on chemistry than on genetics.  Most biotechnology companies are still in the start-up mode, which means they are not yet profitable and instead are consuming investors' capital on research and development in order to develop new products, such as human therapeutics.

Time line of Biotechnology –

B.C. 8000 - Humans domesticate crops and livestock.  Potatoes first cultivated for food.

4000-2000 - Biotechnology first used to leaven bread and ferment beer, using yeast (Egypt).  Production of cheese and fermentation of wine (Samar, China and Egypt).
Babylonians control date palm breeding by selectively pollinating female trees with pollen from certain male trees.

500 - First antibiotic:  moldy soybean curds used to treat boils (China).

A.D. 100 - First insecticide:  powdered chrysanthemums (China).

1322 - An Arab chieftain first uses artificial insemination to produce superior horses.

1590 - Janssen invents the microscope.

1663 - Hooke discovers existence of the cell.

1675 - Leeuwenhoek discovers bacteria.

1761 - Koelreuter reports successful crossbreeding of crop plants in different species.

1797 - Jenner inoculates a child with a viral vaccine to protect him from smallpox.

1830-1833

1830 – Proteins discovered.

1833 – First enzyme discovered and isolated.

1835-1855 - Schleiden and Schwann propose that all organisms are composed of cells, and Virchow declares, "Every cell arises from a cell."

1857 - Pasteur proposes microbes cause fermentation.

1859 - Charles Darwin publishes the theory of evolution by natural selection. The concept of carefully selecting parents and culling the variable progeny greatly influences plant and animal breeders in the late 1800s despite their ignorance of genetics.

1865 - Science of genetics begins: Austrian monk Gregor Mendel studies garden peas and discovers that genetic traits are passed from parents to offspring in a predictable way-the laws of heredity.

1870-1890 - Using Darwin's theory, plant breeders crossbreed cotton, developing hundreds of varieties with superior qualities.

Farmers first inoculate fields with nitrogen-fixing bacteria to improve yields.

William James Beal produces first experimental corn hybrid in the laboratory.

1877 – A technique for staining and identifying bacteria is developed by Koch.

1878 – The first centrifuge is developed by Laval.

1879 – Fleming discovers chromatin, the rod-like structures inside the cell nucleus that later came to be called chromosomes.

1900 - Drosophila (fruit flies) used in early studies of genes.

1902 - The term immunology first appears.

1906 - The term genetics is introduced.

1911 - The first cancer-causing virus is discovered by Rous.

1914 - Bacteria are used to treat sewage for the first time in Manchester, England.

1915 - Phages, or bacterial viruses, are discovered.

1919 - First use of the word biotechnology in print.

1920 - Evans and Long discover the human growth hormone.

1928 - Penicillin discovered as an antibiotic: Alexander Fleming.
A small-scale test of formulated Bacillus thuringiensis (Bt) for corn borer control begins in Europe. Commercial production of this biopesticide begins in France in 1938.
Karpechenko crosses radishes and cabbages, creating fertile offspring between plants in different genera.
Laibach first uses embryo rescue to obtain hybrids from wide crosses in crop plants-known today as hybridization.

1930 - U.S. Congress passes the Plant Patent Act, enabling the products of plant breeding to be patented.

1933 - Hybrid corn, developed by Henry Wallace in the 1920s, is commercialized. Growing hybrid corn eliminates the option of saving seeds. The remarkable yields outweigh the increased costs of annual seed purchases, and by 1945, hybrid corn accounts for 78 percent of U.S.-grown corn.

1938 - The term molecular biology is coined.

1941 - The term genetic engineering is first used by Danish microbiologist A. Jost in a lecture on reproduction in yeast at the technical institute in Lwow, Poland.

1942 - The electron microscope is used to identify and characterize a bacteriophage-a virus that infects bacteria.
Penicillin mass-produced in microbes.

1944 - DNA is proven to carry genetic information – Avery et al.
Waksman isolates streptomycin, an effective antibiotic for tuberculosis.

1946 - Discovery that genetic material from different viruses can be combined to form a new type of virus, an example of genetic recombination.
Recognizing the threat posed by loss of genetic diversity, the U.S. Congress provides funds for systematic and extensive plant collection, preservation and introduction.

1947 - McClintock discovers transposable elements, or "jumping genes," in corn.

1949 - Pauling shows that sickle cell anemia is a "molecular disease" resulting from a mutation in the protein molecule hemoglobin.

1951 - Artificial insemination of livestock using frozen semen is successfully accomplished.

1953 - The scientific journal Nature publishes James Watson and Francis Crick's manuscript describing the double helical structure of DNA, which marks the beginning of the modern era of genetics.

1955 - An enzyme involved in the synthesis of a nucleic acid is isolated for the first time.

1956 - Kornberg discovers the enzyme DNA polymerase I, leading to an understanding of how DNA is replicated.

1958 - Sickle cell anemia is shown to occur due to a change of a single amino acid.
DNA is made in a test tube for the first time.

1959 - Systemic fungicides are developed. The steps in protein biosynthesis are delineated.

Also in the 1950s - Discovery of interferons.
First synthetic antibiotic.

1960 - Exploiting base pairing, hybrid DNA-RNA molecules are created.
Messenger RNA is discovered.

1961 - USDA registers first biopesticide: Bacillus thuringiensis, or Bt.

1963 -New wheat varieties developed by Norman Borlaug increase yields by 70 percent.

1964 - The International Rice Research Institute in the Philippines starts the Green Revolution with new strains of rice that double the yield of previous strains if given sufficient fertilizer.

1965 - Harris and Watkins successfully fuse mouse and human cells.

1966 - The genetic code is cracked, demonstrating that a sequence of three nucleotide bases (a codon) determines each of 20 amino acids.

1967 - The first automatic protein sequencer is perfected.

1969 - An enzyme is synthesized in vitro for the first time.

1970 - Norman Borlaug receives the Nobel Peace Prize (see 1963).
Discovery of restriction enzymes that cut and splice genetic material, opening the way for gene cloning.

1971 - First complete synthesis of a gene.

1972 - The DNA composition of humans is discovered to be 99 percent similar to that of chimpanzees and gorillas.
Initial work with embryo transfer.

1973 - Stanley Cohen and Herbert Boyer perfect techniques to cut and paste DNA (using restriction enzymes and ligases) and reproduce the new DNA in bacteria.

1974 - The National Institutes of Health forms a Recombinant DNA Advisory Committee to oversee recombinant genetic research.

1975 - Government first urged to develop guidelines for regulating experiments in recombinant DNA:  Asilomar Conference, California.
The first monoclonal antibodies are produced.

1976 - The tools of recombinant DNA are first applied to a human inherited disorder.
Molecular hybridization is used for the prenatal diagnosis of alpha thalassemia.
Yeast genes are expressed in E. coli bacteria.
First time the sequence of base pairs for a specific gene is determined (A, C, T, G).
First guidelines for recombinant DNA experiments released: National Institutes of Health-Recombinant DNA Advisory Committee.

1977 - First expression of human gene in bacteria.
Procedures developed for rapidly sequencing long sections of DNA using electrophoresis.

1978 - High-level structure of virus first identified.
Recombinant human insulin first produced. 
North Carolina scientists show it is possible to introduce specific mutations at specific sites in a DNA molecule.

1979 - Human growth hormone first synthesized.

Also in the 1970s - First commercial company founded to develop genetically engineered products.
Discovery of polymerases.
Techniques for rapid sequencing of nucleotides perfected.
Gene targeting.
RNA splicing.

1980 - The U.S. Supreme Court, in the landmark case Diamond v. Chakrabarty, approves the principle of patenting recombinant life forms, which allows the Exxon oil company to patent an oil-eating microorganism.
The U.S. patent for gene cloning is awarded to Cohen and Boyer.
The first gene-synthesizing machines are developed.
Researchers successfully introduce a human gene-one that codes for the protein interferon-into a bacterium.
Nobel Prize in Chemistry awarded for creation of the first recombinant molecule: Berg, Gilbert, Sanger.

1981 - Scientists at Ohio University produce the first transgenic animals by transferring genes from other animals into mice.
Chinese scientist becomes the first to clone a fish-a golden carp.

1982 - Applied Biosystems, Inc., introduces the first commercial gas phase protein sequencer, dramatically reducing the amount of protein sample needed for sequencing.
First recombinant DNA vaccine for livestock developed.
First biotech drug approved by FDA: human insulin produced in genetically modified bacteria.
First genetic transformation of a plant cell:  petunia.

1983 - The polymerase chain reaction (PCR) technique is conceived. PCR, which uses heat and enzymes to make unlimited copies of genes and gene fragments, later becomes a major tool in biotech research and product development worldwide.
The first genetic transformation of plant cells by TI plasmids is performed.
The first artificial chromosome is synthesized.
The first genetic markers for specific inherited diseases are found.
First whole plant grown from biotechnology: petunia.
First proof that modified plants pass their new traits to offspring: petunia.

1984 - The DNA fingerprinting technique is developed.
The entire genome of the human immunodeficiency virus is cloned and sequenced.

1985 - Genetic markers found for kidney disease and cystic fibrosis.
Genetic fingerprinting entered as evidence in a courtroom.
Transgenic plants resistant to insects, viruses and bacteria are field-tested for the first time.
The NIH approves guidelines for performing gene-therapy experiments in humans.

1986 - First recombinant vaccine for humans: hepatitis B.
First anti-cancer drug produced through biotech: interferon.
The U.S. government publishes the Coordinated Framework for Regulation of Biotechnology, establishing more stringent regulations for rDNA organisms than for those produced with traditional genetic modification techniques.
A University of California-Berkeley chemist describes how to combine antibodies and enzymes (abzymes) to create pharmaceuticals.
The first field tests of transgenic plants (tobacco) are conducted.
The Environmental Protection Agency approves the release of the first transgenic crop-gene-altered tobacco plants.
The OECD Group of National Experts on Safety in Biotechnology states: "Genetic changes from rDNA techniques will often have inherently greater predictability compared to traditional techniques" and "risks associated with rDNA organisms may be assessed in generally the same way as those associated with non-rDNA organisms."

1987 - First approval for field test of modified food plants: virus-resistant tomatoes.
Frostban, a genetically altered bacterium that inhibits frost formation on crop plants, is field-tested on strawberry and potato plants in California, the first authorized outdoor tests of a recombinant bacterium.

1988 - Harvard molecular geneticists are awarded the first U.S. patent for a genetically altered animal-a transgenic mouse.
A patent for a process to make bleach-resistant protease enzymes to use in detergents is awarded.
Congress funds the Human Genome Project, a massive effort to map and sequence the human genetic code as well as the genomes of other species.

1989 - First approval for field test of modified cotton: insect-protected (Bt) cotton.
Plant Genome Project begins.

Also in the 1980s - Studies of DNA used to determine evolutionary history.
Recombinant DNA animal vaccine approved for use in Europe.
Use of microbes in oil spill cleanup: bioremediation technology.
Ribozymes and retinoblastomas identified.

1990 - Chy-Max™, an artificially produced form of the chymosin enzyme for cheese-making, is introduced.  It is the first product of recombinant DNA technology in the U.S. food supply.
The Human Genome Project – an international effort to map all the genes in the human body-is launched.
The first experimental gene therapy treatment is performed successfully on a 4-year-old girl suffering from an immune disorder.
The first transgenic dairy cow-used to produce human milk proteins for infant formula-is created.
First insect-protected corn:  Bt corn.
First food product of biotechnology approved in U.K.:  modified yeast.
First field test of a genetically modified vertebrate:  trout.

1992 - American and British scientists unveil a technique for testing embryos in vitro for genetic abnormalities such as cystic fibrosis and hemophilia.
The FDA declares that transgenic foods are "not inherently dangerous" and do not require special regulation.

1993 - Merging two smaller trade associations creates the Biotechnology Industry Organization (BIO).
FDA approves bovine somatotropin (BST) for increased milk production in dairy cows.

1994 - First FDA approval for a whole food produced through biotechnology: FLAVRSAVR™ tomato.
The first breast cancer gene is discovered.
Approval of recombinant version of human DNase, which breaks down protein accumulation in the lungs of CF patients.
BST commercialized as POSILAC bovine somatotropin.

1995 - The first baboon-to-human bone marrow transplant is performed on an AIDS patient.
The first full gene sequence of a living organism other than a virus is completed, for the bacterium Hemophilus influenzae.
Gene therapy, immune system modulation and recombinantly produced antibodies enter the clinic in the war against cancer.

1996 - The discovery of a gene associated with Parkinson's disease provides an important new avenue of research into the cause and potential treatment of the debilitating neurological ailment.

1997 - First animal cloned from an adult cell: a sheep named Dolly in Scotland.
First weed- and insect-resistant biotech crops commercialized: Roundup Ready® soybeans and Bollgard® insect-protected cotton.
Biotech crops grown commercially on nearly 5 million acres worldwide:  Argentina, Australia, Canada, China, Mexico and the United States.
A group of Oregon researchers claims to have cloned two Rhesus monkeys.
A new DNA technique combines PCR, DNA chips and a computer program to create a new tool in the search for disease-causing genes.

1998 -  University of Hawaii scientists clone three generations of mice from nuclei of adult ovarian cumulus cells.
Human embryonic stem cell lines are established.
Scientists at Japan's Kinki University clone eight identical calves using cells taken from a single adult cow.
The first complete animal genome, for the C. elegans worm, is sequenced.
A rough draft of the human genome map is produced, showing the locations of more than 30,000 genes.
Five Southeast Asian countries form a consortium to develop disease-resistant papayas.

Also in the 1990s - First conviction using genetic fingerprinting in the U.K.
Isolation of gene that clearly participates in the normal process of regulating weight.
Discovery that hereditary colon cancer is caused by defective DNA repair gene.
Recombinant rabies vaccine tested in raccoons.
Biotechnology based biopesticide approved for sale in the United States.
Patents issued for mice with specific transplanted genes.
First European patent on a transgenic animal issued for transgenic mouse sensitive to carcinogens.
Breast cancer susceptibility genes cloned.

2000 - First complete map of a plant genome developed:  Arabidopsis thaliana.
108.9 million acres of biotech crops grown in 13 countries.
"Golden Rice" announcement allows the technology to be available to developing countries in hopes of improving the health of undernourished people and preventing some forms of blindness.
First biotech crop field-tested in Kenya:  virus-resistant sweet potato.
Rough draft of the human genome sequence is announced.

2001 - First complete map of the genome of a food plant completed:  rice.
Scientific journals publish complete human genome sequence.
Researchers in Australia report developing a technique using "hairpin RNA" that vaccinates crop plants against viruses like Barley Yellow Dwarf Virus.
Chinese National Hybrid researchers report developing a "super rice" that could produce double the yield of normal rice.
The European Commission issues rules requiring the labeling of all foods and animal feed derived from GMOs.
Complete DNA sequencing of the agriculturally important bacterium Sinorhizobium meliloti.
A single gene from Arabidopsis inserted into tomato plants to create the first crop able to grow in salty water and soil.
Genome sequence for Agrobacterium tumefaciens, important in agriculture, released.
Researchers grow thale cress that lights up when it is damaged or stressed-a step toward developing hardier, stress-resistant crops.
First comprehensive molecular map completed of the peanut.

Source for the above Timeline:  The Biotech Industry Organizations website Bio.org

Chapter 1 | Table of Contents | Chapter 3

Page Last Reviewed or Updated: 03-Mar-2014