guide to biotechnology 2008 research & development health bioethics innovate industrial & environmental food & agriculture biodefense Biotechnology Industry Organization 1201 Maryland Avenue, SW imagine Suite 900 Washington, DC 20024 intellectual property 202.962.9200 (phone) 202.488.6301 (fax) bio.org inform bio.org The Guide to Biotechnology is compiled by the Biotechnology Industry Organization (BIO) Editors Roxanna Guilford-Blake Debbie Strickland Contributors BIO Staff table of Contents Biotechnology: A Collection of Technologies 1 Regenerative Medicine ................................................. 36 What Is Biotechnology? .................................................. 1 Vaccines ....................................................................... 37 Cells and Biological Molecules ........................................ 1 Plant-Made Pharmaceuticals ........................................ 37 Therapeutic Development Overview .............................. 38 Biotechnology Industry Facts 2 Market Capitalization, 1994–2006 .................................. 3 Agricultural Production Applications 41 U.S. Biotech Industry Statistics: 1995–2006 ................... 3 Crop Biotechnology ...................................................... 41 U.S. Public Companies by Region, 2006 ........................ 4 Forest Biotechnology .................................................... 44 Total Financing, 1998–2007 (in billions of U.S. dollars) .... 4 Animal Biotechnology ................................................... 45 Biotech Industry Financing .............................................. 5 Aquaculture .................................................................. 51 Global Area of Transgenic Crops, 1995–2007: Industrial Time Line 6 and Developing Countries (million acres) .................. 53 Biotechnology Policy Milestones ................................... 15 Global Area of Transgenic Crops in 2006 and 2007 by Country (million acres)............. 53 Technologies and Tools 18 Bioprocessing Technology ............................................ 18 Agricultural Biotech Products on the Market 54 Recombinant DNA Technology ..................................... 18 Food Biotechnology 60 Monoclonal Antibodies ................................................. 19 Improving the Raw Materials ......................................... 60 Cloning ......................................................................... 20 Food Processing .......................................................... 61 Protein Engineering ....................................................... 20 Food Safety Testing ...................................................... 62 Biosensors ................................................................... 21 Nanobiotechnology ...................................................... 21 Industrial and Environmental Applications 63 Microarrays ................................................................... 22 Industrial Sustainability .................................................. 63 Biocatalysts .................................................................. 64 From Biotechnology to Biology: Using Biotech Biofuel .......................................................................... 64 Tools to Understand Life 23 Research Applications of Biotechnology ....................... 23 Existing and Planned U.S. Cellulosic Ethanol Biorefineries .................................................. 66 Putting the Pieces Together: ‘Omics’ and Related Tools .... 27 Green Plastics .............................................................. 67 The Next Step: Using New Knowledge to Develop Products ................................................ 29 Nanotechnology ........................................................... 67 Environmental Biotechnology ........................................ 68 Health Care Applications 32 Industries That Benefit .................................................. 69 Diagnostics ................................................................... 32 Therapeutics ................................................................. 32 Consumer Goods Made With Industrial Biotech 70 Personalized Medicine .................................................. 35 Examples of Industrial Enzymes 71 Biotechnology Industry Organization i Industrial Biotech–Related Sales in Patenting Organisms .................................................... 79 Chemicals, 2005: $95.5 Billion 72 Patent Licensing ........................................................... 80 Recent Patent Developments ....................................... 80 Preparedness for Pandemics and Biodefense 73 A Strategic Asset .......................................................... 73 Ethics 81 Other Approaches ........................................................ 74 Ethical Issues ................................................................ 82 Other Uses 75 BIO Statement of Ethical Principles 86 DNA Fingerprinting ....................................................... 75 Biotechnology Resources 88 Intellectual Property 77 Periodicals, Headline Services and Web Sites ...........88 What Is a Patent? ......................................................... 77 General Science Journals ............................................. 89 The Purpose of a Patent ............................................... 77 Biotech Education and Careers .................................... 89 Patentable Inventions ...............................................78 Selected Recent Reports on Biotechnology .................. 89 Patent Requirements .................................................... 78 The Patent Application .................................................. 79 Glossary of Biotech-related Terms 93 ii Guide to Biotechnology biotechnology: A Collection of Technologies What Is Biotechnology? person’s body has the same DNA. Most DNA is located in the cell nucleus (where it is called nuclear DNA), but a small amount of At its simplest, biotechnology is technology based on biology. From DNA can also be found in another part of the cell called the mito- that perspective, the use of biological processes is hardly noteworthy. chondria (mitochondrial DNA or mtDNA). We began growing crops and raising animals 10,000 years ago to The information in DNA is stored as a code made up of four chemical provide a stable supply of food and clothing. We have used the biologi- bases: adenine (A), guanine (G), cytosine (C) and thymine (T). Hu- cal processes of microorganisms for 6,000 years to make useful food man DNA consists of about 3 billion bases, and more than 99 percent products, such as bread and cheese, and to preserve dairy products. of those bases are the same in all people. The order, or sequence, of Crops? Cheese? That doesn’t sound very exciting. So why does these bases determines the information available for building and biotechnology receive so much attention? maintaining an organism, similar to the way in which letters of the alphabet appear in a certain order to form words and sentences. No The answer is that in the last 40 years we’ve gone from practicing two people, except for identical twins, share the exact same DNA biotechnology at a macro level—breeding animals and crops, for sequences. example—to working with it at a micro level. It was during the 1960s and ’70s that our understanding of biology reached a point DNA bases pair up with each other, A with T and C with G, to form where we could begin to use the smallest parts of organisms—the units called base pairs. Each base is also attached to a sugar molecule biological molecules of which they are composed—in addition to and a phosphate molecule. Together, a base, sugar, and phosphate using whole organisms. are called a nucleotide. Nucleotides are arranged in two long strands that form a spiral called a double helix. Long, continuous strands of An appropriate modern definition of biotechnology would be DNA are organized into chromosomes. Human cells (except for the “the use of cellular and biomolecular processes to solve prob- sex, or germ, cells) have 46 chromosomes, arranged in 23 pairs. Half lems or make useful products.” come from the mother, half from the father. We can get a better handle on the meaning of the wordbiotechnol - Specific sections of DNA that carry the code for particular proteins are ogy by thinking of it in its plural form, biotechnologies. That’s because called genes. When a particular protein is needed, the DNA base pairs biotechnology is a collection of technologies that capitalize on the split, and RNA (ribonucleic acid) bases attach to the open DNA bases, attributes of cells, such as their manufacturing capabilities, and put forming a strand of mRNA (messenger RNA). The mRNA travels to biological molecules, such as DNA and proteins, to work for us. other parts of the cell where the sequence of the mRNA is “read” by other cell structures that make the protein. Cells and Biological Molecules The NIH provides a well-illustrated primer on DNA and genetics, Help Me Understand Genetics. You can download it at http://ghr. Cells are the basic building blocks of all living things. The simplest nlm.nih.gov/. living things, such as yeast, consist of a single, self-sufficient cell. Com- plex creatures more familiar to us, such as plants, animals and humans, WHY IS DNA THE CORNERSTONE OF BIOTECHNOLOGY? are made of many different cell types, each of which performs very Because virtually all cells speak the same genetic language, DNA from