105-553: Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland , that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV), as well as Ebola and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19 . The COVID-19 vaccine Nuvaxovid
210-491: A herbicide ), reduction of spoilage, or improving the nutrient profile of the crop. Examples in non-food crops include production of pharmaceutical agents , biofuels , and other industrially useful goods, as well as for bioremediation . Farmers have widely adopted GM technology. Between 1996 and 2011, the total surface area of land cultivated with GM crops had increased by a factor of 94, from 17,000 to 1,600,000 square kilometers (4,200,000 to 395,400,000 acres). 10% of
315-475: A phase II study in adults for its respiratory syncytial virus vaccine , which would become ResVax. The ResVax trial was encouraging as it showed significant efficacy against respiratory syncytial virus (RSV) infection, using a nanoparticle-based treatment using a recombinant F lipoprotein or saponin , "extracted from the Quillaja saponaria [or?] Molina bark together with cholesterol and phospholipid ." It
420-474: A plasmid vector inserted into the bacterium Escherichia coli . Insulin, widely used for the treatment of diabetes, was previously extracted from the pancreas of abattoir animals (cattle or pigs). The genetically engineered bacteria are able to produce large quantities of synthetic human insulin at relatively low cost. Biotechnology has also enabled emerging therapeutics like gene therapy . The application of biotechnology to basic science (for example through
525-668: A Unified Database System) database is intended to help companies, interested private users and competent authorities to find precise information on the presence, detection and identification of GMOs used in the European Union . The information is provided in English. In 1988, after prompting from the United States Congress , the National Institute of General Medical Sciences ( National Institutes of Health ) (NIGMS) instituted
630-455: A bacterium (of the genus Pseudomonas ) capable of breaking down crude oil, which he proposed to use in treating oil spills. (Chakrabarty's work did not involve gene manipulation but rather the transfer of entire organelles between strains of the Pseudomonas bacterium). The MOSFET invented at Bell Labs between 1955 and 1960, Two years later, Leland C. Clark and Champ Lyons invented
735-559: A booster dose in adults aged 18 and older. The authorization establishes a foundation for future regulatory approvals and Novavax plans to seek full approval in the United States and other markets while emphasizing the importance of vaccine choice in public health measures. In early October 2023, the FDA amended the EUA to include the reformulated Novavax vaccine "updated to include the spike protein from
840-438: A child's parentage (genetic mother and father) or in general a person's ancestry . In addition to studying chromosomes to the level of individual genes, genetic testing in a broader sense includes biochemical tests for the possible presence of genetic diseases, or mutant forms of genes associated with increased risk of developing genetic disorders. Genetic testing identifies changes in chromosomes , genes, or proteins. Most of
945-413: A consortium could be used as industrial microbes to produce precursors of the chemotherapeutic agent paclitaxel by applying the metabolic engineering in a co-culture approach to exploit the benefits from the two microbes. Another example of synthetic biology applications in industrial biotechnology is the re-engineering of the metabolic pathways of E. coli by CRISPR and CRISPRi systems toward
1050-555: A deal with the South Korean government to manufacture their COVID-19 vaccines. The vaccine is also being co-developed (with the Coalition for Epidemic Preparedness Innovations ) in India under the brand name Covovax . CEPI granted Novavax up to $ 399 million to support the development of the candidate vaccine. On September 6, 2021, Novavax and Takeda Pharmaceutical Company announced that
1155-422: A drug's efficacy or toxicity . The purpose of pharmacogenomics is to develop rational means to optimize drug therapy, with respect to the patients' genotype , to ensure maximum efficacy with minimal adverse effects . Such approaches promise the advent of " personalized medicine "; in which drugs and drug combinations are optimized for each individual's unique genetic makeup. Biotechnology has contributed to
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#17328561406581260-410: A food source into another form. Before the time of Charles Darwin 's work and life, animal and plant scientists had already used selective breeding. Darwin added to that body of work with his scientific observations about the ability of science to change species. These accounts contributed to Darwin's theory of natural selection. For thousands of years, humans have used selective breeding to improve
1365-417: A funding mechanism for biotechnology training. Universities nationwide compete for these funds to establish Biotechnology Training Programs (BTPs). Each successful application is generally funded for five years then must be competitively renewed. Graduate students in turn compete for acceptance into a BTP; if accepted, then stipend, tuition and health insurance support are provided for two or three years during
1470-613: A global health crisis, such as Sars in 2002/03 and Zika in 2015/16", and fund research papers on the costs and process of vaccine development. Town & Country listed it as one of the top-10 newsworthy moments from the 2017 Davos. At launch, Norwegian physician John-Arne Røttingen , who led the steering committee for Ebola vaccine trials, served as interim CEO, and CEPI was based at the Norwegian Institute of Public Health in Oslo. In April 2017, Richard J. Hatchett, former director of
1575-536: A harmful microbe are examples of environmental implications of biotechnology. Many cities have installed CityTrees , which use biotechnology to filter pollutants from urban atmospheres. The regulation of genetic engineering concerns approaches taken by governments to assess and manage the risks associated with the use of genetic engineering technology, and the development and release of genetically modified organisms (GMO), including genetically modified crops and genetically modified fish . There are differences in
1680-505: A health emergency. People do not realise that there's no spare capacity in the world's vaccine production system today". CEPI was formally launched at the 2017 WEF in Davos, with an initial investment of US$ 460 million by a consortium that included the governments of Norway, Japan, and Germany, The Wellcome Trust, and the Gates Foundation ; India joined a short time afterwards. In
1785-564: A launch interview with the Financial Times (FT), Gates said that a key goal was to reduce the time to develop vaccines from 10 years to less than 12 months. The initial targets were the six EID viruses with known potential to cause major epidemics, being: MERS , Lassa fever , Nipah virus , Ebola , Marburg fever and Zika . The FT reported CEPI would "build the scientific and technological infrastructure for developing vaccines quickly against pathogens that emerge from nowhere to cause
1890-415: A notable advance in comparison with the lack of studies published in recent years in scientific journals by those companies. Krimsky, Sheldon (2015). "An Illusory Consensus behind GMO Health Assessment". Science, Technology, & Human Values . 40 (6): 883–914. doi : 10.1177/0162243915598381 . S2CID 40855100 . I began this article with the testimonials from respected scientists that there
1995-513: A number of articles some of which have strongly and negatively influenced the public opinion on GM crops and even provoked political actions, such as GMO embargo, share common flaws in the statistical evaluation of the data. Having accounted for these flaws, we conclude that the data presented in these articles does not provide any substantial evidence of GMO harm. The presented articles suggesting possible harm of GMOs received high public attention. However, despite their claims, they actually weaken
2100-434: A number of ecological benefits, if not used in excess. Insect-resistant crops have proven to lower pesticide usage, therefore reducing the environmental impact of pesticides as a whole. However, opponents have objected to GM crops per se on several grounds, including environmental concerns, whether food produced from GM crops is safe, whether GM crops are needed to address the world's food needs, and economic concerns raised by
2205-546: A promising method to combat malnutrition in India and other countries. Industrial biotechnology (known mainly in Europe as white biotechnology) is the application of biotechnology for industrial purposes, including industrial fermentation . It includes the practice of using cells such as microorganisms , or components of cells like enzymes , to generate industrially useful products in sectors such as chemicals, food and feed, detergents, paper and pulp, textiles and biofuels . In
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#17328561406582310-471: A pure microbiological culture in an industrial process, that of manufacturing corn starch using Clostridium acetobutylicum , to produce acetone , which the United Kingdom desperately needed to manufacture explosives during World War I . Biotechnology has also led to the development of antibiotics. In 1928, Alexander Fleming discovered the mold Penicillium . His work led to the purification of
2415-493: A second time, which resulted in a major downturn in investor confidence and a seventy percent reduction in capital value for the firm. As a secondary result, the company was forced to conduct a reverse stock split in order to maintain Nasdaq minimum qualification, meaning it was in risk of being delisted . NanoFlu is a quadrivalent influenza vaccine , which completed Phase II clinical trials successfully in 2019. In January 2020, it
2520-441: A three-part strategy for 2017: cost reduction through restructuring and the termination of 30% of their workforce; pouring more effort into getting ResVax to market; and beginning clinical trials on a Zika virus vaccine. Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization . In 2019, late-stage clinical testing of ResVax failed for
2625-523: A vaccine candidate, named NVX-CoV2373 , to establish immunity to SARS-CoV-2 . NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus. Novavax's work is in competition for vaccine development among dozens of other companies. In January 2021, the company released phase III trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants. It has applied for emergency use in
2730-624: A vision for the world to be able to respond to a pandemic threat with a new vaccine within 100 days. CEPI was conceived in 2015 and formally launched in 2017 at the World Economic Forum (WEF) in Davos , Switzerland. It was co-founded and co-funded with US$ 460 million from the Bill and Melinda Gates Foundation , the Wellcome Trust , and the governments of India and Norway , and was later joined by
2835-501: A way that preserves trial volunteer privacy (see AllTrials for further information). Pharmaceutical corporations, including Johnson & Johnson , Pfizer , and Takeda , objected to the original policy, and these provisions were removed in December 2018, after the CEPI had obtained significant funding. The policy changes met with strong criticism, led by Médecins Sans Frontières . CEPI
2940-414: A wide range of procedures for modifying living organisms for human purposes, going back to domestication of animals, cultivation of plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization . Modern usage also includes genetic engineering, as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as
3045-521: Is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging infectious diseases (EID). CEPI is focused on the World Health Organization 's (WHO) " blueprint priority diseases ", which include: the Middle East respiratory syndrome-related coronavirus ( MERS-CoV ),
3150-507: Is a rapidly evolving field with significant potential to address pressing global challenges and improve the quality of life for people around the world; however, despite its numerous benefits, it also poses ethical and societal challenges, such as questions around genetic modification and intellectual property rights . As a result, there is ongoing debate and regulation surrounding the use and application of biotechnology in various industries and fields. The concept of biotechnology encompasses
3255-682: Is aimed at stimulating resistance to RSV infection, targeting both adult and infant populations. 2016 saw the company's first phase III trial , the 12,000 adult Resolve trial, for its RSV vaccine, which would come to be known as ResVax, fail in September. This triggered an eighty-five percent dive in the company's stock price. Phase II adult trial results also released in 2016 showed a stimulation of antigenicity, but failure in efficacy. Evaluation of these results suggested that an alternative dosing strategy might lead to success, leading to plans to run new phase II trials. The company's difficulties in 2016 led to
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3360-635: Is based on the basic biological sciences (e.g., molecular biology , biochemistry , cell biology , embryology , genetics , microbiology ) and conversely provides methods to support and perform basic research in biology. Biotechnology is the research and development in the laboratory using bioinformatics for exploration, extraction, exploitation, and production from any living organisms and any source of biomass by means of biochemical engineering where high value-added products could be planned (reproduced by biosynthesis , for example), forecasted, formulated, developed, manufactured, and marketed for
3465-603: Is by far the largest vaccine development initiative ever against viruses that are potential epidemic threats". In 2020, CEPI was identified by several media outlets as a "key player in the race to develop a vaccine" for coronavirus disease 2019 . At its launch in 2017, CEPI announced five-year financial pledges from its founders that amounted to US$ 460 million and came from the sovereign governments of Japan (US$ 125 million), Norway (US$ 120 million), and Germany (US$ 10.6 million in 2017 alone, and which later became US$ 90 million), and from global foundations of
3570-638: Is considered one of the essential cornerstones in industrial biotechnology due to its financial and sustainable contribution to the manufacturing sector. Jointly biotechnology and synthetic biology play a crucial role in generating cost-effective products with nature-friendly features by using bio-based production instead of fossil-based. Synthetic biology can be used to engineer model microorganisms , such as Escherichia coli , by genome editing tools to enhance their ability to produce bio-based products, such as bioproduction of medicines and biofuels . For instance, E. coli and Saccharomyces cerevisiae in
3675-859: Is expected to be good news for the biotechnology sector, with the Department of Energy estimating ethanol usage could reduce U.S. petroleum-derived fuel consumption by up to 30% by 2030. The biotechnology sector has allowed the U.S. farming industry to rapidly increase its supply of corn and soybeans—the main inputs into biofuels—by developing genetically modified seeds that resist pests and drought. By increasing farm productivity, biotechnology boosts biofuel production. Biotechnology has applications in four major industrial areas, including health care (medical), crop production and agriculture, non-food (industrial) uses of crops and other products (e.g., biodegradable plastics , vegetable oil , biofuels ), and environmental uses. For example, one application of biotechnology
3780-565: Is literally no scientific controversy over the health effects of GMOs. My investigation into the scientific literature tells another story. And contrast: Panchin, Alexander Y.; Tuzhikov, Alexander I. (January 14, 2016). "Published GMO studies find no evidence of harm when corrected for multiple comparisons". Critical Reviews in Biotechnology . 37 (2): 213–217. doi : 10.3109/07388551.2015.1130684 . ISSN 0738-8551 . PMID 26767435 . S2CID 11786594 . Here, we show that
3885-477: Is not going to solve this problem because epidemics do not come along very often — and when they do you are not allowed to charge some huge premium price for the tools involved". CEPI's creation was also supported and co-funded by the pharmaceutical industry including GlaxoSmithKline (GSK), with CEO Sir Andrew Witty explaining at the WEF, "It is super-disruptive when the red phone rings in our vaccine division because of
3990-404: Is part of CEPI's effort to enable the world to reduce vaccine development timelines to 100 days. The founding mission of CEPI was "equitable access" in pandemics: selling vaccines to developing nations at affordable prices. Affordable access to existing patented vaccines had long been a concern for the medical community, and concern mounted in the wake of the struggle to get access to vaccine in
4095-673: Is the application of the principles of engineering and natural sciences to tissues, cells, and molecules. This can be considered as the use of knowledge from working with and manipulating biology to achieve a result that can improve functions in plants and animals. Relatedly, biomedical engineering is an overlapping field that often draws upon and applies biotechnology (by various definitions), especially in certain sub-fields of biomedical or chemical engineering such as tissue engineering , biopharmaceutical engineering , and genetic engineering . Although not normally what first comes to mind, many forms of human-derived agriculture clearly fit
4200-708: Is the directed use of microorganisms for the manufacture of organic products (examples include beer and milk products). Another example is using naturally present bacteria by the mining industry in bioleaching . Biotechnology is also used to recycle, treat waste, clean up sites contaminated by industrial activities ( bioremediation ), and also to produce biological weapons . A series of derived terms have been coined to identify several branches of biotechnology, for example: In medicine, modern biotechnology has many applications in areas such as pharmaceutical drug discoveries and production, pharmacogenomics , and genetic testing (or genetic screening ). In 2021, nearly 40% of
4305-498: Is used in Novavax's approved vaccine for COVID-19 ( NVX-CoV2373 ). 39°08′14″N 77°13′36″W / 39.1371°N 77.2267°W / 39.1371; -77.2267 Biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and engineering sciences in order to achieve the application of organisms and parts thereof for products and services. The term biotechnology
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4410-488: Is widely used in biomedical applications, such as the detection of DNA hybridization , biomarker detection from blood , antibody detection, glucose measurement, pH sensing, and genetic technology . By the mid-1980s, other BioFETs had been developed, including the gas sensor FET (GASFET), pressure sensor FET (PRESSFET), chemical field-effect transistor (ChemFET), reference ISFET (REFET), enzyme-modified FET (ENFET) and immunologically modified FET (IMFET). By
4515-427: The 2013–2016 Ebola epidemic . Averting a repetition of this crisis was the motivating factor behind founding CEPI. CEPI's original policy contained specific measures to prevent some of these market problems. All vaccine-manufacturing contracts would need initial approval by a public review board. The policy also stated that vaccine prices would be set at levels affordable to those needing vaccines and sustainable to
4620-419: The Bill and Melinda Gates Foundation to support the development of a vaccine against RSV for infants via maternal immunization. In May 2020, Novavax received US$ 384 million from the Coalition for Epidemic Preparedness Innovations to fund early-stage evaluation in healthy adults of the company's COVID-19 vaccine candidate NVX-CoV2373 and to develop resources in preparation for large-scale manufacturing, if
4725-631: The DNA of which has been modified with genetic engineering techniques. In most cases, the main aim is to introduce a new trait that does not occur naturally in the species. Biotechnology firms can contribute to future food security by improving the nutrition and viability of urban agriculture. Furthermore, the protection of intellectual property rights encourages private sector investment in agrobiotechnology. Examples in food crops include resistance to certain pests, diseases, stressful environmental conditions, resistance to chemical treatments (e.g. resistance to
4830-522: The European Union (2019) and the United Kingdom (2020). CEPI is headquartered in Oslo , Norway. The concept for CEPI was outlined in a July 2015 paper in The New England Journal of Medicine , titled "Establishing a Global Vaccine-Development Fund", co-authored by British medical researcher Jeremy Farrar (a director of Wellcome Trust ), American physician Stanley A. Plotkin (co-discoverer of
4935-477: The Federal Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373 , and on June 7, FDA's panel of outside advisors recommended FDA grant the EUA. In February 2022, Health Canada authorized Nuvaxovid for the prevention of COVID-19 in adults 18 years of age and older. On 13 July 2022, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for
5040-461: The Human Genome Project ) has also dramatically improved our understanding of biology and as our scientific knowledge of normal and disease biology has increased, our ability to develop new medicines to treat previously untreatable diseases has increased as well. Genetic testing allows the genetic diagnosis of vulnerabilities to inherited diseases , and can also be used to determine
5145-692: The International Finance Facility for Immunisation (IFFIm) issued NOK 600 million in vaccine bonds to front-load the commitment by Norway, through Gavi, the Vaccine Alliance , to CEPI. In March 2019, the European Commission granted access to CEPI into the EU's Horizon 2020 programme, and a longer-term financial funding programme. CEPI note presentations that the EU's financial commitment amounts to US$ 200 million, which when added to
5250-579: The National Agency of Drug and Food Control of Indonesia , or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name Covovax. On December 17, 2021, the World Health Organization (WHO) added Novavax's Covovax vaccine, jointly developed with
5355-570: The Rubella vaccine), and American expert in infectious diseases Adel Mahmoud (developer of the HPV vaccine and rotavirus vaccine ). Their concept was further expanded at the 2016 WEF in Davos, where it was discussed as a solution to the problems encountered in developing and distributing a vaccine for the Western African Ebola virus epidemic . Co-founder and funder, Bill Gates said: "The market
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#17328561406585460-672: The Severe acute respiratory syndrome coronavirus 2 ( SARS-CoV-2 ), the Nipah virus , the Lassa fever virus , and the Rift Valley fever virus, as well as the Chikungunya virus and the hypothetical, unknown pathogen " Disease X ". CEPI investment also requires "equitable access" to the vaccines during outbreaks , although subsequent CEPI policy changes may have compromised this criterion. In 2022, CEPI adopted
5565-410: The EU and approval for import and processing. While only a few GMOs have been approved for cultivation in the EU a number of GMOs have been approved for import and processing. The cultivation of GMOs has triggered a debate about the coexistence of GM and non-GM crops. Depending on the coexistence regulations, incentives for the cultivation of GM crops differ. The EUginius (European GMO Initiative for
5670-695: The Gates Foundation (US$ 100 million), and the Wellcome Trust (US$ 100 million); India was finalising their financial commitment, which was made shortly afterward. A funding target of US$ 1 billion was set for the first 5 years of operation (i.e. by January 2022). The journal Nature said of the amount raised that: "It is by far the largest vaccine development initiative ever against viruses that are potential epidemic threats". As part of its funding structure, CEPI has used "vaccine bonds" to "frontload" multi-year sovereign funding pledges. In 2019,
5775-471: The Government of Japan's Ministry of Health, Labour and Welfare will purchase 150 million doses of Novavax's vaccine candidate TAK-019 pending regulatory approval. The Government of Japan's Ministry of Health, Labour and Welfare signed an agreement with Takeda Pharmaceutical Company for Takeda to manufacture and distribute Novavax's TAK-019 upon regulatory approval. On December 22, 2021, Novavax confirmed
5880-498: The Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. In July 2023, Novavax announced that it has received full Marketing Authorization from the European Commission for its COVID-19 vaccine, Nuvaxovid ( NVX-CoV2373 ), allowing its use as a primary series in individuals aged 12 and older and as
5985-700: The SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023–2024 formula)" for age 12 and above. In December 2023, the WHO provided prequalification status to the R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India. Novavax also develops proprietary immune-stimulating saponin -based immunologic adjuvants at a wholly-owned Swedish subsidiary, Novavax AB. One of these, Matrix-M,
6090-550: The Serum Institute of India (SII), to the list of approved coronavirus vaccines for emergency use. The vaccine can then be used in the Covax programme for the supply of vaccines to low and middle income countries. Novavax and SII provide Covax program with 1.1 billion doses of vaccine. On 20 December 2021, the European Medicines Agency recommended Novavax's Nuvaxovid vaccine for conditional marketing authorisation, which
6195-814: The U.S. government's Biomedical Advanced Research and Development Authority (BARDA), became the full-time CEO. Hatchett was also a member of the United States Homeland Security Council under George W. Bush , and the United States National Security Council , under Barack Obama . Also in April 2017, CEPI opened an additional office in London, and in October 2017, a further office was opened in Washington, D.C. Nature later stated, "It
6300-595: The US and UK but will be distributed in the UK first. As of May 2021, the company does not anticipate that it will file for approval in the UK "until July at the earliest". On 14 June 2021, Novavax announced overall 90.4% efficacy in the Phase 3 US and Mexico trial. Of the total 77 cases of COVID-19 among the trial's volunteers, 14 occurred in the vaccine group, while 63 occurred in the placebo group. On May 22, 2021, Novavax and Moderna announced
6405-518: The antibiotic compound formed by the mold by Howard Florey , Ernst Boris Chain and Norman Heatley – to form what we today know as penicillin . In 1940, penicillin became available for medicinal use to treat bacterial infections in humans. The field of modern biotechnology is generally thought of as having been born in 1971 when Paul Berg's (Stanford) experiments in gene splicing had early success. Herbert W. Boyer (Univ. Calif. at San Francisco) and Stanley N. Cohen (Stanford) significantly advanced
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#17328561406586510-502: The application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials and organisms, such as pharmaceuticals, crops, and livestock . As per the European Federation of Biotechnology , biotechnology is the integration of natural science and organisms, cells, parts thereof, and molecular analogues for products and services. Biotechnology
6615-462: The broad definition of "utilizing a biotechnological system to make products". Indeed, the cultivation of plants may be viewed as the earliest biotechnological enterprise. Agriculture has been theorized to have become the dominant way of producing food since the Neolithic Revolution . Through early biotechnology, the earliest farmers selected and bred the best-suited crops (e.g., those with
6720-404: The business realities confronted by vaccine developers". It said that several unnamed vaccine manufacturers had declared that they could not work with the CEPI under the original policy. It said that the policy change did not reflect a change in commitment to access, and CEPI would still retain the right to do research and development using intellectual property it had funded, if the old partner
6825-523: The company that had received the funding and taken ownership of the IP later withdrew from the agreement with CEPI. The original policy also required that funded parties pre-register any trials in a clinical trials registry , publish results within a year of study completion (except with compelling reason and permission of CEPI), publish results in open-access articles, and have mechanisms for securely sharing underlying data and results, including negative results, in
6930-509: The course of their PhD thesis work. Nineteen institutions offer NIGMS supported BTPs. Biotechnology training is also offered at the undergraduate level and in community colleges. But see also: Domingo, José L.; Bordonaba, Jordi Giné (2011). "A literature review on the safety assessment of genetically modified plants" (PDF) . Environment International . 37 (4): 734–742. Bibcode : 2011EnInt..37..734D . doi : 10.1016/j.envint.2011.01.003 . PMID 21296423 . Archived (PDF) from
7035-445: The current decades, significant progress has been done in creating genetically modified organisms (GMOs) that enhance the diversity of applications and economical viability of industrial biotechnology. By using renewable raw materials to produce a variety of chemicals and fuels, industrial biotechnology is actively advancing towards lowering greenhouse gas emissions and moving away from a petrochemical-based economy. Synthetic biology
7140-488: The difference between beneficial biotechnology (e.g., bioremediation is to clean up an oil spill or hazard chemical leak) versus the adverse effects stemming from biotechnological enterprises (e.g., flow of genetic material from transgenic organisms into wild strains) can be seen as applications and implications, respectively. Cleaning up environmental wastes is an example of an application of environmental biotechnology ; whereas loss of biodiversity or loss of containment of
7245-458: The discovery and manufacturing of traditional small molecule pharmaceutical drugs as well as drugs that are the product of biotechnology – biopharmaceutics . Modern biotechnology can be used to manufacture existing medicines relatively easily and cheaply. The first genetically engineered products were medicines designed to treat human diseases. To cite one example, in 1978 Genentech developed synthetic humanized insulin by joining its gene with
7350-402: The early 2000s, BioFETs such as the DNA field-effect transistor (DNAFET), gene-modified FET (GenFET) and cell-potential BioFET (CPFET) had been developed. A factor influencing the biotechnology sector's success is improved intellectual property rights legislation—and enforcement—worldwide, as well as strengthened demand for medical and pharmaceutical products. Rising demand for biofuels
7455-455: The efficacy of two doses of vaccine against the omicron variant of SARS-CoV-2 . The new data suggest that the vaccine provides an immune response against the Omicron variant and other variants of the coronavirus . The response of antibodies against omicron is four times lower than the original variant. A third dose of the vaccine given to adults, six months after the first two doses, increased
7560-448: The evidence for the harm and lack of substantial equivalency of studied GMOs. We emphasize that with over 1783 published articles on GMOs over the last 10 years it is expected that some of them should have reported undesired differences between GMOs and conventional crops even if no such differences exist in reality. and Coalition for Epidemic Preparedness Innovations The Coalition for Epidemic Preparedness Innovations ( CEPI )
7665-607: The fact these organisms are subject to intellectual property law. Biotechnology has several applications in the realm of food security. Crops like Golden rice are engineered to have higher nutritional content, and there is potential for food products with longer shelf lives. Though not a form of agricultural biotechnology, vaccines can help prevent diseases found in animal agriculture. Additionally, agricultural biotechnology can expedite breeding processes in order to yield faster results and provide greater quantities of food. Transgenic biofortification in cereals has been considered as
7770-468: The first biosensor in 1962. Biosensor MOSFETs were later developed, and they have since been widely used to measure physical , chemical , biological and environmental parameters. The first BioFET was the ion-sensitive field-effect transistor (ISFET), invented by Piet Bergveld in 1970. It is a special type of MOSFET, where the metal gate is replaced by an ion -sensitive membrane , electrolyte solution and reference electrode . The ISFET
7875-416: The first forms of biotechnology. These processes also were included in early fermentation of beer . These processes were introduced in early Mesopotamia , Egypt , China and India , and still use the same basic biological methods. In brewing , malted grains (containing enzymes ) convert starch from grains into sugar and then adding specific yeasts to produce beer. In this process, carbohydrates in
7980-416: The grains broke down into alcohols, such as ethanol. Later, other cultures produced the process of lactic acid fermentation , which produced other preserved foods, such as soy sauce . Fermentation was also used in this time period to produce leavened bread . Although the process of fermentation was not fully understood until Louis Pasteur 's work in 1857, it is still the first use of biotechnology to convert
8085-478: The highest yields) to produce enough food to support a growing population. As crops and fields became increasingly large and difficult to maintain, it was discovered that specific organisms and their by-products could effectively fertilize , restore nitrogen , and control pests . Throughout the history of agriculture, farmers have inadvertently altered the genetics of their crops through introducing them to new environments and breeding them with other plants — one of
8190-420: The key techniques used in biotechnology is genetic engineering , which allows scientists to modify the genetic makeup of organisms to achieve desired outcomes. This can involve inserting genes from one organism into another, and consequently, create new traits or modifying existing ones. Other important techniques used in biotechnology include tissue culture, which allows researchers to grow cells and tissues in
8295-511: The lab for research and medical purposes, and fermentation , which is used to produce a wide range of products such as beer, wine, and cheese. The applications of biotechnology are diverse and have led to the development of essential products like life-saving drugs, biofuels , genetically modified crops, and innovative materials. It has also been used to address environmental challenges, such as developing biodegradable plastics and using microorganisms to clean up contaminated sites. Biotechnology
8400-515: The level of neutralizing antibodies against the omicron variant by 73.5 times, making it more effective in preventing omicron from entering human cells . The data shows that the 73.5-fold increase in antibody level following a third dose of Novavax vaccine ( protein subunit vaccine) was higher than the booster doses of Pfizer and Moderna ( mRNA vaccines ), which increased the antibody levels 25-fold and 37-fold, respectively. On November 1, 2021, Novavax and Serum Institute of India announced that
8505-440: The manufacturer. Trade secrets would not be funded by the CEPI. Companies had to share all research data developed with CEPI funds. While CEPI would, controversially, not retain and license the intellectual property developed with CEPI funds (allowing the groups awarded funding to own it), the CEPI retained "step-in" rights: the right to license and use intellectual property developed with CEPI funds for vaccine production, even if
8610-669: The market, but in 2015 the FDA approved the first GM salmon for commercial production and consumption. There is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, but that each GM food needs to be tested on a case-by-case basis before introduction. Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe. The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation. GM crops also provide
8715-810: The methods of genetic engineering . These techniques have allowed for the introduction of new crop traits as well as a far greater control over a food's genetic structure than previously afforded by methods such as selective breeding and mutation breeding . Commercial sale of genetically modified foods began in 1994, when Calgene first marketed its Flavr Savr delayed ripening tomato. To date most genetic modification of foods have primarily focused on cash crops in high demand by farmers such as soybean , corn , canola , and cotton seed oil . These have been engineered for resistance to pathogens and herbicides and better nutrient profiles. GM livestock have also been experimentally developed; in November 2013 none were available on
8820-531: The new technology in 1972 by transferring genetic material into a bacterium, such that the imported material would be reproduced. The commercial viability of a biotechnology industry was significantly expanded on June 16, 1980, when the United States Supreme Court ruled that a genetically modified microorganism could be patented in the case of Diamond v. Chakrabarty . Indian-born Ananda Chakrabarty , working for General Electric , had modified
8925-404: The original on October 9, 2022. In spite of this, the number of studies specifically focused on safety assessment of GM plants is still limited. However, it is important to remark that for the first time, a certain equilibrium in the number of research groups suggesting, on the basis of their studies, that a number of varieties of GM products (mainly maize and soybeans) are as safe and nutritious as
9030-457: The production of a chemical known as 1,4-butanediol , which is used in fiber manufacturing. In order to produce 1,4-butanediol, the authors alter the metabolic regulation of the Escherichia coli by CRISPR to induce point mutation in the glt A gene, knockout of the sad gene, and knock-in six genes ( cat 1, suc D, 4hbd , cat 2, bld , and bdh ). Whereas CRISPRi system used to knockdown
9135-460: The production of crops and livestock to use them for food. In selective breeding, organisms with desirable characteristics are mated to produce offspring with the same characteristics. For example, this technique was used with corn to produce the largest and sweetest crops. In the early twentieth century scientists gained a greater understanding of microbiology and explored ways of manufacturing specific products. In 1917, Chaim Weizmann first used
9240-441: The products). The utilization of biological processes, organisms or systems to produce products that are anticipated to improve human lives is termed biotechnology. By contrast, bioengineering is generally thought of as a related field that more heavily emphasizes higher systems approaches (not necessarily the altering or using of biological materials directly ) for interfacing with and utilizing living things. Bioengineering
9345-422: The purpose of sustainable operations (for the return from bottomless initial investment on R & D) and gaining durable patents rights (for exclusives rights for sales, and prior to this to receive national and international approval from the results on animal experiment and human experiment, especially on the pharmaceutical branch of biotechnology to prevent any undetected side-effects or safety concerns by using
9450-422: The regulation of GMOs between countries, with some of the most marked differences occurring between the US and Europe. Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety. The European Union differentiates between approval for cultivation within
9555-404: The respective conventional non-GM plant, and those raising still serious concerns, was observed. Moreover, it is worth mentioning that most of the studies demonstrating that GM foods are as nutritional and safe as those obtained by conventional breeding, have been performed by biotechnology companies or associates, which are also responsible of commercializing these GM plants. Anyhow, this represents
9660-538: The seed amount (including the full German commitment), came to US$ 740 million. By February 2020, Bloomberg News reported that CEPI had raised a total of US$ 760 million with additional donations from the governments of Australia, Belgium, Canada, and the U.K. Bloomberg said that "CEPI solves what economists call a 'coordination problem'. It can help pair boutique research and development companies with big vaccine manufacturers, work with regulators to streamline approval processes and resolve patent disputes on
9765-551: The spot. Its scientific advisory committee has executives from Pfizer, Johnson & Johnson, and Japan's Takeda Pharmaceutical, among others". In March 2020, the British government pledged £210 million in funding to CEPI to specifically focus on a vaccine for the coronavirus; making Britain CEPI's largest individual donor. In January 2022, The Wellcome Trust and the Bill & Melinda Gates Foundation pledged $ 300 million to CEPI. This
9870-534: The three competing genes ( gab D, ybg C, and tes B) that affect the biosynthesis pathway of 1,4-butanediol. Consequently, the yield of 1,4-butanediol significantly increased from 0.9 to 1.8 g/L. Environmental biotechnology includes various disciplines that play an essential role in reducing environmental waste and providing environmentally safe processes, such as biofiltration and biodegradation . The environment can be affected by biotechnologies, both positively and adversely. Vallero and others have argued that
9975-542: The time, testing is used to find changes that are associated with inherited disorders. The results of a genetic test can confirm or rule out a suspected genetic condition or help determine a person's chance of developing or passing on a genetic disorder . As of 2011 several hundred genetic tests were in use. Since genetic testing may open up ethical or psychological problems, genetic testing is often accompanied by genetic counseling . Genetically modified crops ("GM crops", or "biotech crops") are plants used in agriculture ,
10080-565: The total company value of pharmaceutical biotech companies worldwide were active in Oncology with Neurology and Rare Diseases being the other two big applications. Pharmacogenomics (a combination of pharmacology and genomics ) is the technology that analyses how genetic makeup affects an individual's response to drugs. Researchers in the field investigate the influence of genetic variation on drug responses in patients by correlating gene expression or single-nucleotide polymorphisms with
10185-593: The vaccine proves successful. CEPI had already invested $ 4 million in March. On July 7, 2020, during the Donald Trump administration, the company was awarded a US$ 1.6 billion loan from the United States government from Operation Warp Speed program to cover the testing, commercialization and production of a potential coronavirus vaccine in the United States, with a goal of delivering 100 million doses by January 2021. In January 2020, Novavax announced development of
10290-507: The world's crop lands were planted with GM crops in 2010. As of 2011, 11 different transgenic crops were grown commercially on 395 million acres (160 million hectares) in 29 countries such as the US, Brazil , Argentina , India , Canada, China, Paraguay, Pakistan, South Africa, Uruguay, Bolivia, Australia, Philippines, Myanmar, Burkina Faso, Mexico and Spain. Genetically modified foods are foods produced from organisms that have had specific changes introduced into their DNA with
10395-430: Was also criticized for not following its own policies on transparency, and for removing the requirement that CEPI's board review CEPI's contracts. The CEPI stated that its vaccines would continue to be affordable and available, and published an article discussing the changes, saying that the old policy "while reflective of the idealism that inspired the creation of CEPI, was felt by others not to be pragmatic or reflect
10500-664: Was approved in the European Union at the end of 2021, and in Canada in February 2022, as the fifth vaccine against COVID-19, following Pfizer/BioNTech , Moderna , Janssen and AstraZeneca . In June 2013, Novavax acquired the Matrix-M adjuvant platform with the purchase of Swedish company Isconova AB and renamed its new subsidiary Novavax AB. In March 2015, the company completed a Phase I trial for its Ebola vaccine candidate, as well as
10605-451: Was first used by Károly Ereky in 1919 to refer to the production of products from raw materials with the aid of living organisms. The core principle of biotechnology involves harnessing biological systems and organisms, such as bacteria, yeast , and plants, to perform specific tasks or produce valuable substances. Biotechnology had a significant impact on many areas of society, from medicine to agriculture to environmental science . One of
10710-653: Was formally approved by the European Commission, making it the fifth approved COVID-19 vaccine in the European Union after Pfizer/BioNTech, Moderna, Janssen and AstraZeneca. On 20 January 2022, The Therapeutic Goods Administration (TGA) has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID. This is the first protein COVID-19 vaccine to receive regulatory approval in Australia. On 31 January 2022, Novavax applied to
10815-434: Was granted fast track designation by the U.S. Food and Drug Administration (FDA) to move into Phase III trials, which completed in March 2020. Novavax is financed by both public and private investors , of which approximately 50% of the free float shares are held by institutional investors . Novavax is funded by a mix of private and public investment. In 2015, Novavax received a US$ 89 million research grant from
10920-447: Was nominated for the 2021 Nobel Peace Prize by Norwegian MP Carl-Erik Grimstad . CEPI is incorporated under Norwegian law . As of March 2020, a full-time staff of 68 that runs the organisation under the direction of a chief executive officer, Richard Hatchett. In October 2018, CEPI scientists estimated that the costs of developing at least one vaccine for each of the diseases that could escalate into global humanitarian crises
11025-608: Was unable to continue. It also said that the CEPI would retain the right to find a new manufacturer if the old manufacturer could not continue, provided the old manufacturer agrees to the transfer of the information and intellectual property to the new one. The New York Times said that CEPI had made a "failed effort to get large pharmaceutical firms to agree to be partners without insisting on substantial profits or proprietary rights to research that CEPI helped to finance and produce," and had replaced specific implementation measures with lip service to its funding mission. The coalition
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