MAB Unit 1 Notes PDF

1.1 What is Biotechnology & What Does it Mean To You? Biotechnology: Using living organisms, or products of living organisms to benefit humans in making a product or solving a problem *MEMORIZE DEFINITION* - Using living things (e.g. plants, bacteria, fungi) to make things beneficial for humans...

1.1 What is Biotechnology & What Does it Mean To You? Biotechnology: Using living organisms, or products of living organisms to benefit humans in making a product or solving a problem *MEMORIZE DEFINITION* - Using living things (e.g. plants, bacteria, fungi) to make things beneficial for humans - Fermentation (microbes to break things down and change the products - e.g. sour cream) - Benefits: making money, more nutritional value, enzymes to modify blue jeans - Vaccines with antibodies are also examples of biotechnology History of Biotechnology: 2000 B.C. (general time-line, record of occurrence) Using things in the environment - didn’t know it was yeast - but mix flour & water Yeast to make bread, alcohol, yogurt, & cheese Fermentation (lactic acid fermentation, exercise, and burn in muscles) Egyptians, Babylonians, Romans, Greeks, Chinese Sourdough - make your yeast Sacromices in the environment allow bread to rise, sugars in flour to be broken down into CO2, and air bubbles in bread Selective Breeding & Animal Domestication ○ Selective breeding: choosing desirable traits and combining them ○ E.g. corn bred to be larger and contain more kernels (bigger and juicer) ○ E.g. turkeys bred to have larger and more tender turkey breasts ○ Selective breeding is still common today! Dogs selectively breed, as well. Model Organisms ○ Casper fish ○ Can see blood vessels, spine, bones, etc. ○ Created by the Children’s Hospital (Boston) ○ Selectively breed by mating fish that lacked reflective pigment x lacked black pigment (doesn’t reflect light nor have dark pigment) ○ Can learn how cells can migrate in the body ○ Can observe how cancer cells can metastasize and spread throughout the body ○ Zebrafish 1928 ○ Alexander Fleming discovered Penicillium mold contains an antibiotic now known as penicillin, a contaminant on plate ○ Area around the plate where bacteria doesn’t grow (around the contaminant) ○ When penicillium landed, produced penicillin (an antibiotic that kills bacteria) 1940’s  ○ Penicillin treats S. aureus and has become widely available 1960’s ○ Batch processes from many different bacterial strains ○ Large bioreactors vats of bacteria in agar that create bacteria for us ○ Mass-produced ○ Different types of antibiotics for different types of bacteria MRSA: bacterial strain resistant to antibiotics 1960’s -> Today Gene cloning (copy of a gene) Modify other organisms to make GMOs ○ Products that are useful to us a.k.a. biotechnology Genetic engineering ○ A portion of the gene inserted into another organism rDNA technology ○ Observe pieces of DNA similar to each other ○ Also monitor pieces of RNA ○ DNA -> RNA -> protein how it is genetically modified ○ E.g. golden rice (higher Vitamin A content for vision - beta carotene) 1990-2003 Human Genome Project ○ Combo of scientists from different fields ○ Sequencing tech available but not advanced enough to rapidly generate and synthesize data ○ Group together many pieces of data from the human genome (they used karyotypes) ○ Areas that didn’t get sequenced (repeated letters) ○ Actually completed the Human Genome Project rn ○ Zoom in chromosomes to get a gene map ○ Genes work in connection with each other (e.g. multiple genes work together to cause breast cancer) HGP -> Genomics ○ Study of all genes in an organism Synthetic Genomes ○ Can create a genome for an organism that is entirely pieces of DNA combined by humans - instead of reproduction and the formation of offspring CRISPR-Casg ○ Jennifer Goudna  ○ Bacteria have an immune system ○ Detect a foreign piece of DNA and cut it in specific areas ○ Molecular scissors and allows insertion of new DNA in that spot ○ 2016 scientist changed ppl’s DNA ○ False DNA could be passed from gen to gen DIY Biotechnology Open Insulin Project ○ Create affordable, open-source insulin ○ A more efficient model for production Genspace, Brooklyn NY ○ Lab space you can rent and do experiments in Products of Modern Biotech Genetech - Insulin ○ Produced by the pancreas when eating things high in carbohydrates/sugar ○ People with diabetes don’t have enough insulin, high blood sugar ○ Insulin is produced w/ bacteria instead of naturally Cancer Drugs ○ Not only chemotherapy ○ Drugs target cancer cells Gene Therapy ○ Product of a gene that someone is deficient in ○ E.g. sickle cell amenia (cell has comma shape) Mutation in one letter of the gene Enzymes ○ Amylase & Cellulase ○ End with -ase ○ Responsible for breaking things down (metabolism) Creation of Humulin (Human Insulin) A genetically engineered version of insulin = Humulin ○ Identify the gene of interest (gene for insulin) ○ Introduce this gene to bacterial or mammalian cells ○ Cells grown on culture plates (choose the cells in the gene of interest and grow them in a fermentor) ○ Allow cells to produce the protein of interest that comes from the gene (a.k.a. insulin) ○ DNA -> RNA -> protein (central dogma) ○ Recombinant protein: derived from DNA from 2 or more sources Isolate protein and distribute it to individuals Blue squiggles are insulin (the protein) Ethics Cloning ○ E.g. Dolly the sheep ○ She had a mother but looked the same as her mother ○ Died prematurely - successful in cloning, but not successful in quality and lifespan Gene Editing ○ Where do you draw the line between treatment or personal desires 1.1 (Textbook Notes) What is Biotechnology & What Does It Mean to You? A non bruising apple/potato Treated w a monoclonal antibody Corn chip, sour cream, yogurt, cheese Flu shot Antibiotic Biotechnology: The science of using living organisms, or the products of living organisms, for human benefit (or to benefit human surroundings)- to make a product or solve a problem. - New discipline that involves ancient practices - Old & new approaches to biotech make the field rapidly changing A Brief History of Biotechnology: DNA cloning, the genetic manipulation of organisms, and even cloning entire organisms require modern-day techniques Many applications represent old practices w/ new methodologies Humans have been using other biological organisms for their benefit for many years E.g. Chinese, Greeks, Romans, Babylonians, and Egyptians, involved w/ biotech since 2000 B.C. Biotech does not equal hunting and gathering animals for consumption Domestication is an example of biotech Early ancestors relied on microorganisms and fermentation to make breads, cheeses, yogurts, and alcoholic beverages, like beer and wine Fermentation: some strains of yeast decompose sugars to obtain energy - Ethanol = waste product - In bread dough formation, yeast like Saccharomyces cerevisiae (baker’s yeast) is added to make the dough rise - This occurs, as fermentation yeast release carbon dioxide, causing the dough to rise and forming holes in the bread - Alcohol produced by the yeast evaporates when the bread is cooked Selective breeding: Organisms w/ desirable features are purposely mated to produce offspring with the same desirable characteristics - Humans have used selective breeding as a biotech application - E.g. cross-breeding plants to produce the best corn and for farmers to maximize their land (to make the most desirable crops) - Farm animals (including turkeys - breed birds producing the largest & most tender breast meat, cows, chickens, and pigs - Wild species of plants (e.g. lettuces, strawberries, cabbages, and bananas) may be bred over many gens and cultivated for human consumption - No expensive labs and high-tech equipment required for the manipulation of genes ❌ Zebrafish are experimental model organisms - Scientists at the Children’s Hospital of Boston produced a transparent zebrafish (Casper) - Created by mating a zebrafish that lacked reflective pigment with a zebrafish that lacked black pigment - Casper has also been important for drug testing and in vivo (the living organism) studies of stem cells and cancer - E.g. how cancer cells metastasize (spread) - Scientists injected fluorescent tumor cells into the fish’s abdominal cavity to track the migration of cells to specific locations in the body Antibiotics: Substances produced by microorganisms, inhibiting the growth of other microorganisms - Penicillin became widely available for medicinal use to treat bacterial infections - Advances in biotech and and cell bio allowed large amounts of antibiotics to be purified from many different strains of bacteria - Batch (large-scale) processes: scientists can grow bacteria & other cells in large amounts and harvest useful products in large batches - Isolated the commercially important molecules from microorganisms Gene cloning: The ability to identify & reproduce a gene of interest, and genetic engineering, manipulating the DNA of an organism - Scientists can combine DNA from different sources through genetic engineering - Recombinant DNA (rDNA) tech: produces hundreds of recombinant proteins of medical importance, such as insulin, human growth hormone, and blood-clotting factors - rDNA has many applications, such as the development of disease-resistant plants, food crops that produce greater yields, crops engineered to be more nutritious, and genetically engineered bacteria that can degrade environmental pollutants - Combines DNA from different sources The Human Genome Project was initiated in 1990, serving as the ultimate cloning project  - Was an international research effort w/ goals to identify & sequence all genes in the DNA of human cells (the genome) and to map gene locations to each of the 24 human chromosomes (1 to 22 and the X and Y chromosomes) - Revealed the chromosomal location and sequence of every human gene - Readily available in public databases and free - Significantly advanced the development of new diagnostic tools for detecting genetic diseases - A new era of research known as genomics (study of the genomes) including DNA sequencing. - Can sequence the genomes of virtually any species & have resulted in the ability to sequence individual human genomes, from analyzing genetic ancestry to genetic testing and disease diagnosis Artificial/synthetic genomes too! Genome editing based on CRISPR-Cas, to correctly identify diseases and allow novel genetic modification DIY (do-it-yourself) biotechnology: moves biotech & related applications away from traditional research environments - DIY participants = “biohackers” - Apple cofounders Steve Jobs and Steve Wozniak built when building first circuit boards at home - Inexpensive instruments for amplifying DNA and detecting malaria have resulted from DIY biotech - Baskic gene-cloning experiments in the kitchen - 4 years ago, a group of undergraduate students in a genome course at JHU announced a synthetic ver of yeast chromosome 3 w/ only essential elements of the genome - Crowdsource funding via online fundraising campaigns, etc. - DIY scientists sometimes work in unregulated ways - German authorities discovered pathogenic (causing disease) antibiotic-resistant bacteria in a CRISPR kit sent from California - Kit had common gut microbes - Declared the environmental risk of modifying these drug-resistant bacteria as insignificant but banned all such imports from the company Odin except to certified high-safety laboratories that have some governmental oversight - Ppl can do anything w/DIY biotech, as long as they work in a don’t work in an unregulated environment the work is not illegal Biotechnology: A Science of Many Disciplines Biotech is an expansive, interdisciplinary field The roots are formed from the basic scientists - research into fundamental processes of living organisms at the biochemical, molecular, and genetic levels  Biotech applications create products/processes to help humans or our living environment Bioinformatics: using comp sci in sophisticated ways to study the sequence of a gene & analyze the structure of the protein produced by the gene Products of Modern Biotech: - More than 65% of biotech companies in the US are involved in producing medicines for the treatment of human health conditions - Many of these medicine are recombinant proteins, as they are produced through gene cloning/recombinant DNA techniques - 1982, the Cali biotech company Genentech, the world’s first biotech company, received approval for recombinant insulin, for the treatment of diabetes - There are now many drugs, vaccines, and diagnostics on the market, w/ over 350 biotech medicines in development, targeting over 200 diseases Drug Development by the biotech industry is focused on combating major diseases that affect humans & over half of the new drugs in the development are designed to treat cancer 2017 - a banner year for new biotech drug approvals w/ 46 novel drugs approved in the US 2nd only to 1996 when 53 biotech drugs were approved Cancer drugs have the most approvals Diagnosis and/or treatment of a variety of human diseases and disorders (e.g. immunodeficiency syndrome AIDS, stroke, diabetes, and cancer) make up the bulk of biotech products in the market Gene therapy approaches treat & cure human disease conditions ○ Involves delivering genes to treat/cure a genetic disorder ○ Genes and tissue engineering can foster the growth of organs for transplants that are rarely rejected ○ Can be used to treat cancers, strokes, and arthritis Ethics and Biotechnology: Powerful applications and promise of biotech, such as DIY experiments, raise many ethical concerns Foster discussion among scientists, clergy, politicians, lawyers, and the general public Cloning in mammals like sheep, cows, and monkeys led some to suggest that human cloning should be permitted Creating a baby thru cloning? Potential for genome editing to create embryos w/ desired gene characteristics has raised many ethically challenging questions 1.2 Types of Biotechnology Microbial Biotechnology:  First Uses: yeast to make bread and wine Current Uses: ○ Making vaccines ○ Produce batch amounts of insulin and growth hormone, along with other medically valuable proteins ○ Also used to make foods Agricultural Biotechnology: Predicted 9.1 billion people by 2050 ○ Need to increase food production Genetically manipulate plants: ○ Cold tolerant ○ Drought resistance Resistance to herbicides that kill plants Has nutritional value ○ Greater food yield Concern is possibly creation of “super weeds” by gene transfer E.g. Goldern rice ○ Using gene transfer in order for some of the genes could be taken up by neighboring plants ○ Allow farmers to produce more crops per acre (the process of manipulating and producing a pharmaceutical product) - Molecular farming (we do this w/ tobacco right now) Animal Biotechnology: Animals can produce medically valuable proteins (antibodies) ○ Antibodies are protective proteins that recognize and help the body destroy foreign materials ○ Improve their immunity or to people that have immune system disorder Transgenic female animals produce proteins in milk Model organisms ○ Mice and rats are similar to humans ○ Transgenic animals are created from another source E.g. transgenic animals that produce clotting factors which are present in our blood to treat people that have hemophilia 1997, taking a nucleus from one of your body cells and putting it into an egg, dolly later developed complications and was euthanized in 2003. New kidney, lung, or organ, animals can be used Very controversial field Knocking out genes, has been performed in mice and rats Forensic Biotechnology: Used for DNA fingerprinting - a collection of methods for detecting an organism’s unique DNA pattern ○ Used in: Law enforcement Endangered species Track and confirm organisms that spread disease Used to convict a rapist Bioremediation: Using biotechnology to process and degrade a variety of natural and human-made substances, specifically the ones that pollute the environment ○ Exxon Valdez ○ 1998 large oil spill occurred off the coast of Alaska ○ Spilled about 10 million gallons of oil ○ Oil-degrading bacteria present in the soil, are deployed to degrade more of the oil that’s present Aquatic Biotechnology: Aquaculture: Raising fish or shellfish, in controlled conditions, for food ○ Ex: trout, salmon, catfish Bioprospecting efforts identify and discover organisms with properties that may be exploited for commercialization Withstand extreme conditions (e.g. extreme heat or extreme pressure) Medical Biotechnology: Produce recombinant therapies Gene therapy: approaches in which genetic diseases can be treated by inserting a normal gene into a patient ○ Will be more common in the future ○ Recombinant proteins and inject them into individuals Stem cells: immature cells that have not yet been specialized Biotech Regulations: Biotech products must be carefully examined before use One of the most heavily regulated industries Two important aspects of the regulatory process include: ○ Quality assurance (QA): regulates the final quality of the product ○ Quantity control (QC): ensure consistent product standards 1.3 Human Genome Project: Numerous problems and challenges have the potential to be solved by biotechnology Landmark was the creation of a rough draft of the human genome, which revealed humans have roughly 3 billion base pairs Updates put estimates likely between 20,000-25,000 genes Telomeres at the end of repeated segments of DNA Not adequate tech to sequence DNA Can detect diseases pre-birth, treat individuals more effectively Template of one person’s DNA, using it to determine others Future of Biotech: This discovery leads to enormous potential, including: ○ Greater understanding of genetics & evolution ○ Do studies on organisms that are not humans and compare ○ Transform practical medicine Someone’s genetic material responds well Better understanding of disease helps decipher the proteome (collection of proteins in an organism) Lots of DNA that doesn’t form proteins (DNA -> mRNA -> protein) ○ Only if DNA is expressed, it form proteins ○ Can help treat & diagnose patients Future: Identifying genes involved in disease provides valuable resources. This can be helpful in a variety of ways: ○ Not all patients respond to routinely prescribed medicines ○ Early detections possible (to foster healthier lifestyles) ○ New, safer, and more effective treatment strategies to cure disease SNPs: (single nucleotide polymorphisms) Are point mutations ○ One letter changed into a different letter ○ Permanent changes in DNA sequences that vary from one individual to another The diagnosis of genetic diseases are epxected to be furthered through this Represent one of the most common examples of genetic variation SNP Info: May influence our responses to stress & disease May cause disease (e.g. Sickle cell anemia or disease)  Will help identify genes involved in arthritis, stroke, cancer, heart disease, and emotional illnesses, along with many others Changing one letter causes different protein 3 nucleotides form codons that form proteins Identify genes involved with other types of diseases ○ E.g. Stroke risk SNPs in Biotech: Another goal of HGP is to identify SNPs and create SNP maps of the human genome Where in DNA are the SNPs are located Again, testing a person’s DNA for different SNPs will identify disease genes that a person may have ○ This can be accomplished using a DNA microarray (gene chip) ○ With 100s of DNA sequences (single-stranded pieces) ○ Run gel (run DNA through the gel) ○ DNA will bind to the complementary pieces, already in the well ○ Single-stranded pieces where they bind, color change that computer can detect complementary piece being bonded ○ No color change -> no pieces of DNA binding ○ Polymorphism: Many pieces of DNA can be in one spot A Brave New Field: Discovery of SNPs is partially responsible for pharmacogenomics (customized medicine based on a patient’s genome) SNP analysis identifies genes involved with a disease (example = arthritis, which may be caused by many genes), so physician can design a drug treatment strategy (specific & most effective more patient. Pharmacogenomics: Scientists can group people into haplotypes for SNP analysis. The word haplotype is a contraction of “haploid genotype.” At a basic level, people with the same SNP’s in a designated region are placed into the same haplotype group. Same ideas of pharmacogenomics can be applied for cancers, especially since a main strategy involves chemotherapy (drugs that have a toxic effect on diseased cells) Can we design chemotherapy drugs that will not affect normal cells? Metabolomics (biochemical snapshot of small molecules produced by cellular metabolism) May be used to monitor drug effects on disease states ○ E.g. insulin & cholestrol & ATP Treating & Curing Genetic Disease: The latest advancements in biotech lead us closer to strategies that will help to treat and cure genetic diseases. Many strategies that are currently on the horizon include: Nanotechnology (extremely small particles/devices) Gene therapy (replacing/augmenting defective genes) Small interfering RNA (gene silencing) ○ Stops translation from happening ○ RNA cannot become protein Stem cell tech Stem Cells: Have the ability to grow & divide into a variety of tissues They differentiate (specialize) when given certain cues/signals Embryonic (ES cells) = obtained from embryos Adult-derived (ASCs) = isolated from adult tissues Induced pluripotent stem cells (iPSCs) = acquired without the use of embryo Regenerative medicine describes approach (using stem cells to replace/regrow damaged tissue) 1.3 (Textbook) A Scenario in the Future: How Might We Benefit from the Human Genome Project: 2001 was a landmark in the biotech timeline Best molecular biologists gathered to announce the rough draft of the human genome The DNA sequence read as the letters A, C, G, and T of human chromosomes was almost complete Having the chromosomal location and sequencing of all genes in the human genome has increased our understanding of the complexity of human genetics The human genome doesn’t directly solve all our medical problems! We require an understanding of the structures and functions of proteins ○ Proteome: The collection of proteins responsible for human cells Some drugs only work for some patients and in others, have little to no effect We need to understand genome information to result in the rapid, sensitive, and early detection and diagnosis of genetic disease conditions in humans of all ages In arthritis, we know that there are different forms and that they have similar symptoms Sequencing entire individual genomes, or personal genomics, and at relatively low cost is being implemented These applications use SNP’s (single nucleotide polymorphism) to determine DNA sequences that vary from individual to individual E.g. sickle cell anemia, testing or sequencing one’s DNA for different SNPs allows the identification of specific disease genes that a person might be carrying  ○ The discovery of SNPs is responsible for personalized/precision medicine/past referred to as pharmacogenomics ○ This is a customized medicine, involving tailor-designing drug therapy and treatment strategies based on the specific genetic profile of a patient ○ The most specific and effective treatment approach ○ Some genes passed down thru familial inheritance, while others thru additional factors/nongenetic ones like lack of exercise ○ Thus, a simple blood test can be used to prepare DNA for genetic analysis involve in the specific form of a disease a person has ○ Massive databases can be studied, but diagnostic tools are required for precision-guided therapies ○ Nanotechnology, or tech requiring extremely small devices, has rapidly emerged ○ Small particles can deliver drugs to cells, along with RNA, antibodies, or even immune cells ○ Gene therapy tech has been used to replace/augment defect genes w/ normal copies ○ Stem cell tech is also rapidly emerging, allowing the formation of almost any tissue of engineering, depending on how they are treated ○ Can also study drug interactions, before they are administered to patients ○ Regenerative medicine: scientists can collect stem cells, genetically manipulate them via gene therapy, and inject them Gel Electrophoresis: Electro = flow of electricity -phoresis = to carry across A gel is a colloid, a suspension of tiny particles in a medium, occurring in a solid form (like gelatin). Gel electrophoresis refers to the separati Why do gel electrophoresis? When DNA is cut by restriction enzymes*, the result is a mix of DNA pieces of different lengths It is useful to be able to separate the pieces of DNA (for recovering particular pieces of DNA, for forensic work or for sequencing) Not sequence entirety of genome, only specific sequence How does it work? DNA is an organic acid, and is negatively charged When the DNA is exposed to an electrical field, the particles migrate toward the positive electrode Dyes in the middle because some are negatively charged, others positively charged Separates the dyes  Smaller pieces of DNA can travel further in a given time than large pieces What is needed? Agarose is a polysaccharide made from seaweed ○ Polysaccharide: many sugars connected together ○ It is dissolved in buffer and heated, then cools to a gelatinous solid with a network of crosslinked molecules ○ Some gels are made with acrylamide if sharper bands are required (protein separation) E.g. PAGE gel Different gels: Most agarose gels are made between 0.8% and 2% ○ A 0.8% gel will show good resolution (separation) of large DNA fragments (5-10kb) or kilobases ○ A 2% gel will show good resolution for small fragments (0.2-1 kb) or kilobases ○ More agarose, close together (smaller pores) -> good for smaller DNA fragments ○ Low-percentage gels are weak and may break ○ High-percentage gels are brittle What is needed? Buffer - either TBE or TAE ○ The buffer provides ions in solution to ensure electrical conductivity ○ Not only is the agarose dissolved in buffer, but the gel slab is submerged (submarine gel) in buffer after solidifying ○ DNA fragments move from negative to positive because of current Also needed are a power supply and a gel chamber ○ Safety mechanisms Visualizing DNA: Most of the time Ethidium bromide (EtBr) is used ○ A fluorescent dye visualized when excited by UV light ○ Intercalated into the DNA molecule, staining it Gel is soaked in a solution of EtBR and the DNA bands take up thedye Then the gel is placed under UV light and visualized and/or photographed However… Ethidium Bromide is a mutagen So we will use EtBR staining cards, which only carry trace amounts and minmize student exposure to the compound We will use SyberSafe  ○ UV light produces green hue DNA ladders: Frequently, one of the wells in your gel will contain a DNA ladder This is used as a marker to compare the sample DNA fragments and estimate their size ○ Compare the original samples in the DNA sample to the one you made Helpful Hints: When placing the gel in the electrophoresis chamber: Make sure that the wells are closest to the negative (black) electrode (since DNA is negative) When adding the buffer to the chamber: Gently flood the gel from the end opposite the wells to minimize sample diffusion Before loading the wells: Orient the entire chamber close to the power supply so it is in place when the samples are ready to run Helpful Hints: When loading samples in the wells of the gel: Use proper micropipette techniques Make a written record of which sample you will load in each well of the gel (LABEL) Be careful not to puncture the bottoms of the wells as you load the samples If you make a mistake, do NOT take more than the allotted sample; there are limited amounts 1.4 The Biotechnology Workforce Biotech Company Revenue: Biotech companies continue to grow, and many companies like Pfizer saw record revenue stats due to the COVID-19 vaccine. Top Revenue Producers in 2023: 1) J & J - $85.16 billion 2) Roche - $65.32 billion 3) Merck - $60.1 billion  4) Pfizer - $58.5 billion 5) AbbVie - $54.3 billion How to Start a Biotech Company: General “start-ups” that are created due to venture capitalists (companies, endowments, foundations) and angel investors (individual private donor) Angel investors typically get ownership It can take 10+ years to get product to market Successful start-ups usually purchased by larger companies Careers in Biotech: Biotech scientists must be comfortable with DNA sequence data, gene expression data, computer modeling, DNA/protein structure analysis, & chemical data There are over 1,500 biotech companies in the U.S. Many career opportunities exist within the following 4 areas: 1) Research & development (R & D) 2) Operations (Product Development, Manufacturing & Production) 3) Quality assurance & quality control (QA & QC) a) Meeting all safety regulations 4) Clinical Research a) Human trials b) Before Drugs and biotech products get approval, test within a small group of humans c) Pre-clinical trials - testing in bacteria & mice and seeing how a drug/product works 5) Finance & Administration a) Lots of revenue, so need people enforcing policy Research & Development: These careers are involved in discovering & developing new products. They consume close to 50% of the operating budget. Positions include: ○ Laboratory technician, Research Assistant, Principal/senior, scientists, & Bioinformatics among many others Bioinformatics: The crossroads of biotech & comp sci where programs are designed to analyze biological data These jobs include organizing, analyzing, & sharing DNA/protein sequence information Manufacturing & Production: These careers are responsible for developing and maintaining the tech & innovative equipment that drives industry research.  Involves scale-up processes (products made on a large scale) Positions include: Material handlers, manufacturing assistants, manufacturing associates, and Engineering positions (chemical, electrical, environmental, industrial) Quality Assurance & Quality Control: Involve meeting stringent regulations, maintaining documentation, along with addressing customer inquiries & complaints. Positions include: Validation technician, document clerk, QC inspector, Customer relation specialist Clinical Research: Once a product has successfully navigated the pre-clinical process it can get approved for human trials (clinical trials) Strict regulatory standards Positions include: Clinical research manager, regulatory affairs, clinical data manager Finance & Admin: Finance positions involve deriving more funds from investors Sales and Marketing promote the company product Legal specialists maintain legal standards for copyright, obtaining patients, and naming rights Positions include: Finance, Business Development, Administration, Legal, Information Systems, Facilities, Sales Representatives, Marketing Specialists 1.4 Textbook 1976, Genentech a small company near San Francisco, Cali, was founded - Part of the Roche group since 2009, is recognized as the first biotech company! - Revenue of the U.S. biotech companies have grown by more than 10% annually over the past decade - Biotherapeutic drugs contribute greatly to the revenue (excess of $225 billion worldwide) and doubling every 5 years - Many biotech companies are working on cures for cancer - Nearly 40% of Americans receive a diagnosis of cancer in their lifetimes Top Regions for Biotech Jobs in the US 95% of biotech companies are encompassed in North America, Europe, Japan, but biotech companies found in over 54 countries Countries without a traditional history in R & D (research and development) are turning to biotech for high-tech innovations (e.g. India and China) Over 700 public biotech companies in the U.S.  Various trade publications, such as Genetic Engineering & Biotechnology News, evaluate employment data West coast: San Francisc, San Diego, and Los Angeles Northwest: Seattle East Coast: Boston & Cambridge, along with NY PA, bc of unis South: MD and northern VA Contract Research Organizations (CROS) provide specific services for biotech companies What is a Biotech company? Pharmaceutical companies: involved in drug development by chemical synthesizing for purifying compounds Don’t use living organisms to grow or produce a product But over the past few decades, lots of pharmaceutical companies involved w/biotech company research Biotech companies begin as start-ups, formed by a small team of scientists who believe that they might have a promising product Seek investors to fund their company ○ But at least 40% of biotech companies close w/out providing any return to their investors ○ Rely on financial investments, or capital Venture capital, money provided bc they see potential! Angel investors provide capital and funds VC investments are the essential pipeline of funds that supports biotech copanies 2007-2008, 46% decrease in VC investments bc only enough cashflow for 12 months or less It takes around 10 years, many companies are bought by larger ones Initial Public offering: available for the public to purchase shares of company stock Jobs in Biotech: Employs over 200,000 ppl R & D: directly involved in the process of developing ideas and running experiments thru recombinant proteins Lots of trial and error! R & D budget is close to 50% of the operating budget! R & D positions require a bachelor’s/associate’s degree in bio, chem, or biotchem Laboratory technicians: are involved w/ duties like cleaning and maintaining equipment ○ Require B.A.  Research assistant/associate carry out experiments under direct supervision of established//experienced scientists ○ Involved w/ design, reviewing of literature, etc. Principle/senior scientists: usually have a PhD and considerable practical experience ○ Plan and execute research projects ○ Given to the top financial managers of a company Bioinformatics: The use of computers to analyze & store DNA and protein data, requires understanding of computer programming and stats ○ Self-trained in comp sci, database analysis, math ○ Take classes in biotech and 4 year colleges train ppl to become bioinformaticists Data scientists and analysts are needed to observe data Operations, biomanufacturing, and production: Divisions in product development Includes scale-up processes, when things are grown on a large scale Biomanufacturing and production units maintain and monitor the large-scale and large-volume equipment Supervisory & management require master/bachelor degree in bio/chem/several years of experience in manufacturing Involves engineering training ○ B.A. degree or M.S. degree in bio/area of engineering Quality assurance & Quality Control: Quality assurance: ensures final quality of product is guaranteed Quality control: designed to ensure the products meet stringent regulations by federal agencies Also monitor equipment, facilities, personnel, etc. Jobs usually require at least a B.S. degree Costumer relation specialist/product complaint specialists work in the QA divisions to follow up w/consumers Clinical research & regulatory affairs: Requires volunteer subjects The clinical trial process is regulated by agencies Biotech companies involved w/clinical research have large divisions w/science and neuroscience personnel who conduct and oversee clinical trials Marketing, sales, finance, and legal divisions: Most people employed in biotech marketing have a B.S. degree Sales reps work with medical doctors, hospitals, etc. to promote a company’s product Marketing specialists do advertising campaigns to target customer needs  Financial divisions: run by VPs or chief financial officers who oversee finance and are involved in raising funds from partners of venture capitalists Legal specialists: work on legal issues, like copyrights ○ Staff will also address legal circumstances that may arise if there are problems with a product/litigation from a user of a product Salaries in Biotech: Ppl are always making groundbreaking discoveries Biotech has only been around for about 40 years, so is new Salaries for life scientists in the commercial sector is higher then those paid to academia Biotech company salary>professional sciences salary More than 400 biotech companies, w no work experience, $55, 750, w senior scientists earning $120,000 56% of the college students entering biotech training have little to no science bg Good positions are available to people w a proper bg in bio and good lab skills, but increasing educational training is becoming a requirement for employment Hiring Trends: Since 1992, the industry has tripled in size Emphasis on unis and biotech hubs and therapeutics has expanded a mainstream population of patients, ppl w/ unique skill combos and good “soft skills” (technical skills) have better opportunities