Biotechnology

the Science, the Products, the Government, the Business

Ronald P. Evens

• Publisher: CRC Press
• Year: 2020
• eBook ISBN: 9780429678677
• Edition: 1
• Topic: Medicine
• Subtopic: Pharmaceutical, Biotechnology & Healthcare Industry

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies.

Features

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• Comprehensive coverage of biotechnology science topics used in development and manufacturing

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• Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline

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• Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

chapter one

Introduction

The scientific revolution in drug discovery, product development, and patient care that occurred near the end of the twentieth century, that is, the advent and full realization of the value and applications of biotechnology in health care, continues unabated and even accelerated into the twenty-first century. The growth and advances in biotechnology have been remarkable in science (multiple novel technologies created and numerous new products approved), in disease management (myriad indications, great extent of disease mitigation, and even manifold cures), and in the business arena (extensive list of varied biotech companies, universal pharma companies’ engagement, billion-dollar investments, and blockbuster sales). In the early era of biotech product approvals, we observed only 15 new products in the 1980s, which improved to 67 in the 1990s, over this 18-year pre-millennial period. After 2000, this discipline of biotechnology has experienced more than a quadrupling of the discovery, development, production, and commercialization of innovative biological products, with about 360 more products by the end of 2019 (a second 18-year period). Moreover, over 375 human disease conditions now are treated with the 442 biotechnology products, many of which continue to be major medical breakthroughs, which are marketed by about 100 biotech and pharma companies.

History of biotechnology

The earliest origins of biotechnology harken back thousands of years, employing the process of fermentation to create new food sources. About 8,000 to 4,000 years ago, beer, wine, cheeses, and breads were created by utilizing the rudimentary tools of grains (sources of carbohydrates and proteins to be manipulated into food stuffs), a yeast (a living organism with biochemical and enzymatic properties), and a container vessel in which the source materials, yeasts, and processes can function. Also, genetic manipulation of animal and plants has been performed over many millennia through crossbreeding to create improved traits in plants and animals as food sources and agricultural products for sale. Moldy soy was used in China to treat boils hundreds of years ago. Inoculation against smallpox was performed using extracts from smallpox lesions in the revolutionary British colonies in North America. Genetics began with the discoveries related to heredity by Charles Darwin and Gregor Mendel in the mid-1800s; the principles were used in breeding animals and plants to enhance desirable traits. The existence of proteins was discovered in the 1800s, and DNA being responsible for carrying genetic information was established in 1940s. The first biotech product, that was genetically created, manufactured, clinically studied, and approved for use, was a peptide hormone, recombinant human insulin, which was created in 1982 by the company Genentech. For medical biotechnology and product development, critical discoveries in the biological sciences especially over the preceding 30 years that led to this first product achievement are identified below in a timeline (Table 1.1).

Table 1.1 Timeline for biologic discoveries leading to biotech product development

1663 – Robert Hooke first described living cells. 1677 – Antonie van Leeuwenhoek discovered bacteria and protozoa. 1798 – Edward Jenner was the first to use a viral vaccine as an inoculation for smallpox. 1838 – Gerardus Mulder and Jons Berzeluis discovered and named proteins. 1862 – Louis Pasteur discovered fermentation from bacterial origin. 1863 – Gregor Mendel determined the laws of inheritance. 1869 – Freidrich Miescher identified DNA in trout sperm. 1878 – Walther Flemming discovered chromatin, which lead to the discovery of chromosomes. 1881 – Louis Pasteur created vaccines against bacterial infections, e.g., anthrax. 1888 – Heinrich von Waldeyer-Hartz discovered chromosomes. 1909 – Genes were first linked with hereditary diseases. 1915 – Phages, bacterial viruses, were discovered. 1919 – The word, “biotechnology,” was first used by a Hungarian agricultural engineer, Karl Ereky. 1953 – Drs. James Watson and Francis Crick developed the three-dimensional configuration of DNA with the paired nucleotides and a double helical shape. 1955 – The enzyme, DNA polymerase, responsible for synthesis of nucleic acid-based molecules, was isolated. 1959 – Gerald Edelman and Rodney Robert Porter independently discovered the structure of antibodies. 1960 – Messenger RNA was discovered to carry the genetic code from the nucleus. 1961 – Dr. Marshall Nirenberg established that genetic information in DNA determines protein structure and is related to most cellular functions.

1961–1965 – Genetic code was delineated, responsible for translating the connection between DNA and proteins: • Genetic code (DNA and RNA) was revealed to be generally universal in all living things. • In the genetic code, the four RNA nucleotides (two purines – adenine and guanine and two pyrimidines – uracil and cytosine) in varied triplet codes (over 60 triplets) had a direct relationship to the 20 amino acids in determining the structure of proteins. • The multifaceted and interrelated roles of several RNA species, that is, messenger RNA, ribosomal RNA, and transfer RNA, were elucidated in the transcription and translation processes, resulting in nuclear DNA codes being transformed into the production of proteins in cell cytoplasm. 1963 – The peptide insulin was synthesized. 1964 – Reverse transcriptase enzyme was discovered for creating in reverse order, DNA from RNA. 1970 – Hamilton Smith discovered restriction enzyme, responsible for cutting DNA into fragments, permitting genetic manipulation. 1971 – The biotech company Cetus was founded. 1972 – DNA ligase was used to recombine DNA fragments, further permitting genetic manipulation. 1972 – Dr. Paul Berg combined genes isolated from different organisms (mammalian or bacteria) into a hybrid DNA molecule. 1973 – Drs. Stanley Cohen (Stanford University) and Herbert Boyer (University of California, Berkley) created the first recombinant DNA experiment, inserting a DNA molecule (fragment) into another cell’s DNA with replication/cloning of DNA. 1974 – The National Institutes of Health (NIH) in the United States formed the Recombinant DNA Advisory Committee for oversight of recombinant genetic research. 1975 – Monoclonal antibody technology was developed by Drs. Georges Kohler, Neils Jerne, and Cesar Milstein through hybridoma cell development, that produce antibodies versus specific antigens and demonstrating hybridomas are immortal. 1976 – The biotech company Genentech was founded. 1977 – DNA sequencing techniques were developed, permitting accurate sequencing of genes, separately by both Dr. Walter Gilbert in the United States and Dr. Frederick Sanger in England. 1977 – The human peptide for growth hormone, somatostatin, was produced in a genetically engineered bacteria, a first for cloning of a human protein or peptide with a human gene inserted in a nonhuman organism’s DNA.

1978 – Dr. Herbert Boyer created the first biologically synthetic version of human insulin, inserting a human insulin gene into the bacterium Escherichia coli, producing the first human peptide. 1978 – Antisense was described by Paul Zamecnik and Mary Stephenson. 1978 – The biotech companies Biogen, Agouron, and Hybritech were founded. 1979 – The biotech company Centocor was founded. 1980 – The U.S. Supreme Court decided that genetically altered life forms can be patented, creating tremendous commercial opportunities for genetic engineering. 1980 – The biotech companies Amgen, Genetics Institute, and Genetic Systems were founded. 1980s – Transgenic animals were first created in various livestock. 1981 – ...

Table of contents

• Cover
• Half Title
• Series Page
• Title Page
• Copyright Page
• Table of Contents
• Preface
• Author
• List of abbreviations
• Chapter 1 Introduction
• Chapter 2 Science of biotechnology – Recombinant DNA technology
• Chapter 3 Science of biotechnology – Monoclonal antibody technology
• Chapter 4 The science of biotechnology: Peptides, vaccines, cell and tissue therapy, liposomes, nanobiotechnology, animal-sourced products
• Chapter 5 The science of biotechnology: Molecular engineering (proteins, monoclonal antibodies, biosimilars)
• Chapter 6 The science of biotechnology: Oligonucleotides and genetics
• Chapter 7 Laws and regulations governing biological product approval and usage
• Chapter 8 Biotechnology products and indications I. Proteins
• Chapter 9 Biotechnology products and indications II
• Chapter 10 Biotechnology industry
• Bibliography
• Index