VATIS Update Biotechnology . Jul-Sep 2016
IN THE NEWS
Global economic benefits of GM crops
|According to a study by PG Economics Ltd., the United Kingdom, worldwide economic benefits of genetically modified (GM) crops have reached $150 billion. “Global Socio-Economic and Environmental Impacts 1996-2014”, said farmers who used GM seeds reaped economic benefits averaging more than $100 per hectare (about 2.5 acres) in 2014, while simultaneously improving the environmental sustainability of their operations. The average yield gains over the 1996-2014 period across all users of this technology has been +13.1% for insect resistant corn and +17.3% for insect resistant cotton relative to conventional production systems.|
India’s only permitted commercial GM crop is cotton, adopted in 2002, which contains genes to ward off certain insects. The success of Bt cotton in India has made it the world’s fourth largest GM crop producer, behind the US, Brazil and Argentina. In 2014, the direct global farm income benefit from GM crops was $17.7 billion – equivalent to addition of 7.2% to the value of global production of the four main crops of soybean, maize, canola and cotton, the study said. The total farm income benefit of $150.3 billion was divided almost equally between farmers in developing (51%) and developed countries (49%).
“The highest yield gains were obtained by farmers in developing countries, many of which are resource-poor and farm small plots of land,” it added. Noting that crop biotechnology continues to be a good investment for millions of farmers, the study found farmers globally received an average of $3.59 for each dollar invested in GM crop seeds. “Two-thirds of these benefits derive from higher yields and extra production, with farmers in developing countries seeing the highest gains,” said Graham Brookes, at PG Economics.
Biotechnology investments in India increasing
|India is currently amongst the top 12 biotechnology destinations in the world and ranks third in the Asia-Pacific region. Despite the economic downturn in 2013 to 2014, the industry has experienced rapid growth due to increasing foreign investments, supportive government policies, increasing exports and a skilled workforce. India’s biotechnology industry is in a great position to transition to bio-economy. This will allow India to re-establish cornerstones defining the competitiveness of existing sectors, providing them with a favorable setting to operate and grow.|
A recent white paper from US market research firm Frost & Sullivan, India Ripe for Biotech Industry Growth, finds a fertile ecosystem will enable India to enter the biologics market, which is expected to reach $314.8 billion at a compound annual growth rate (CAGR) of 8.4 percent. India is a global leader in the world generics market, and with its strong positioning to provide affordable healthcare, biosimilars will be a perfect fit for Indian companies. The creation of competitive products and services as well as legislation will direct the paradigm shift from biotechnology to bio-economy.
Bill to setup biotech center in India
|Recently Rajya Sabha has passed a bill providing for setting up a regional centre for Biotechnology, which will act as a mentor institution and focus on training of skilled manpower as well as work on research and development. Science & Technology and Earth Sciences Minister Dr. Harsh Vardhan introduced the Regional Centre for Biotechnology Bill, 2016 and it was passed by voice vote. Government established the Regional Centre for Biotechnology Training and Education at Faridabad in April 2009 through an executive order.|
Now with approval from Parliament, the institute would be able give Masters and Phd degrees, just like the Indian Institute of Science (IISc). The bill provides for establishing a regional biotechnology centre that will work on education, training and research, under the auspices of UNESCO in the National Capital Region. “This centre will take up research and innovation as well as impart education and training in new areas of biotechnology at the interface of multiple disciplines of science creating a hub of technology expertise,” said Dr. Harsh Vardhan.
Gene editing technology trial in China
|Chinese researchers, led by You Lu of Sichuan University, have planned to begin the world’s first CRISPR trial at the West China Hospital, Sichuan University, after being cleared by the hospital’s ethics board. It plans to use the new gene-editing tech, known as CRISPR-Cas-9, on advanced non-small cell lung cancer (NSCLC) patients in a Phase I test primarily designed to test safety, but with secondary endpoints including progression-free survival, overall survival and response rate. The study will use a cocktail of treatments.|
Under the trial’s design, as outlined on clinicaltrials.gov, peripheral blood lymphocytes will be collected and the programmed cell death protein 1 gene will be knocked out by CRISPR-Cas9 in the laboratory (known as PD-1 knockout T cells). The lymphocytes will be selected and expanded ex vivo and then infused back into patients. Cyclophosphamide at 20 mg/kg single dose will be administered 3 days IV before cell infusion. Interleukin-2 (IL-2) will also be given in the following 5 days, with patients getting a total of two, three or four cycles of treatment.
The design is dose escalation of ex-vivo knocked-out, expanded, and selected PD-1 knockout T cells from autologous origin. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Up until now, CRISPR has only been studied in a preclinical setting, but much hype has been generated over the past year with a horde of biotechs and pharmas trying to get in on this potential new class of drug that could alter the way diseases – notably cancer – are treated in the future.
Taiwan biotechnology industryâ€™s output
|Taiwan’s Ministry of Economic Affairs (MOEA) has set a production target for the nation’s biotechnology industry at NT$500 billion (US$15.6 billion) for 2020 with several flagship enterprises of the sector getting annual revenues of more than NT$10 billion. MOEA has elaborated six main strategies for future development of the biotechnology industry in the nation, including the establishment of chains of related enterprises for new drug research and development, the promotion of internationalization of local pharmaceutical manufacturers that obtain certificates of good manufacturing practice PIC/S (pharmaceutical inspection cooperation scheme).|
The other strategies are establishing clusters of manufacturing industries of high-level medical equipments and materials, promoting smart systems of niche medical materials, developing health and welfare industries and amending outdated rules and regulations on new drug development. Taiwan’s biotechnology industry has enjoyed a rapid development in recent years, with the industry’s annual revenue increased to NT$298.6 billion last year from NT$160 billion registered in 2005. In 2015, a total of 1,871 biotechnological enterprises were operating in Taiwan with more than 76,000 employees.
China, Cuba promote exchange in biotech
|Municipal government authorities of Changchun, Jilin province, China, and representatives of BioCubaFarma, Cuba, have reaffirmed their interest in materializing actions for an Industrial Cooperation Area of Biological Technology. Jilin province is already working with Cuban cooperation, the joint venture Changchun Heber Biological Technology, whose main objective is the manufacture of biotechnological products since 2003.|
In May, this year China and Cuba signed a Framework Agreement for the joint construction of a bilateral Industrial Cooperation Area of Biological Technology. The field of Cuban biotechnology is present in the Asian nation through the Biotech joint ventures, located in the Special Development Zone of Beijing. Biotech is the company responsible for producing and marketing the humanized monoclonal antibody Nimotuzumab-R3, obtained by Cuba and used in combined therapy with chemotherapy and radiotherapy in advanced tumors.
First whole genome testing service in Australia
|Australia has launched its first clinical whole genome sequencing service, enabling patients with rare genetic conditions to get a more accurate and faster diagnosis. The new service is the result of collaboration between The Garvan Institute of Medical Research, Australia, and NSW Health Pathology, Australia. The Garvan Institute has established Genome.One as a wholly owned subsidiary to deliver the service. Tests can only be ordered by a clinical geneticist or by specialist physicians supported by a clinical geneticist or genetic counsellors.|
It is hoped the service will improve diagnosis rates for people living with rare genetic conditions, ending the often arduous ‘diagnostic odyssey’ they go through to find answers to their condition. The institute estimates sequencing the genomes of rare disease patients could identify the genetic basis of a disorder in 2-3 times as many patients as is currently the case. “This new service extends cutting-edge genomic technology beyond the research lab,” said Professor John Mattick, at Garvan Institute.
“We’re focusing initially on the area of real unmet need and that is that significant number of Australians who are affected by genetic disease and who lay undiagnosed,” added Professor Mattick. Australia’s genomic facilities have been growing at pace over the last few months. A new Genomics Innovation Hub intended to harness the power of genomic big data has been recently launched, whilst the Australian government has announced funding to establish a new clinical genomic service in Canberra.
China offers incentives to Indian pharma companies
|China, the second largest pharmaceutical market in the world, is luring Indian drug companies to set up greenfield operations in that country. To roll out the red carpet, the local government has decided on a spectrum of incentives like tax benefits and ready availability of resources like infrastructure and manpower at competitive costs. Top level delegates from the People’s government of Hainan province recently met representatives from the Indian pharmaceutical industry like Sun Pharma and Centaur to brief them about the sops to rope in investments.|
The incentives proposed by the Chinese side apply to manufacturing as well as research organisations. The government at Hainan is doling out series of incentives for accelerating industrial development. Industrial incentives include tax subsidy, equipment cost and logistics subsidy. The government representatives also provide some policies like personnel income subsidy, Housing allowance, education environment and etc.
Some of the largest drug makers like Cipla had entered into alliances with local partners Biomab but in 2015 it decided to pull out of its joint venture, mainly focused on sourcing biosimilars. India’s largest drug maker Sun Pharma has a sizable presence in China, mostly inherited as part of the acquisition of Ranbaxy. According to industry estimates, the Chinese pharmaceutical market is set to double to $200 billion by 2020 and the push from the government may continue to attract commensurate investments from US and European drug giants.
Fecal incontinence management system in India
|Aimed to train the next generation of medical technology innovators in India to develop innovative and affordable medical devices to augment unmet clinical needs of India, a fecal incontinence management system ‘Qora’ has been developed under Department of Biotechnology (DBT), Ministry of Science & Technology supported Bio design Programme by M/s. Consure Medical, India. Recently it was launched by Minister of State for Science & Technology Shri Y.S.Chowdary in New Delhi.|
A spin-off from the Program Bio design is a Med-Tech innovation Program of DBT. Fecal incontinence (FI) is a medical condition marked by inability to control one’s bowel movements, causing stool (feces) to leak unexpectedly from the rectum. It affects nearly 100 million bed ridden patients worldwide. Furthermore, about 50% of the psychiatric ward patients have FI due to long-term neurological diseases. Absorbent pads and fecal drainage catheters are the only available solutions for this condition a need for a better solution was felt by the team.
DNA sequencing in space
|Space Exploration Technologies Corporation (SpaceX), the United States, has successfully launched their space station docking port for NASA. It has been reported that the SpaceX’s cargo craft carrying about 2.3 tonnes of equipment and food was sent to the International Space Station (ISS). The most exciting part of this mission is, for the first time in history, a DNA decoder has been sent for conducting research in space!|
The main objective of this mission is to perform DNA sequencing in space itself instead of bringing the samples back to earth which can take considerable amount of time, sometimes several weeks to months. The Biomolecule Sequencer is a miniature DNA sequencing machine developed by Oxford technologies. This sequencer can work in microgravity and is powered via USB connection to a computer or a tablet and runs without a battery.
Datwyler to invest â‚¹453 crore in India
|Datwyler, Switzerland, a supplier of customised sealing solutions to manufacturers and companies operating in the healthcare and automotive industry, Phas announced that it will make 65 million Swiss franc (Rs. 453 crore) investment in India by 2017. The company has been present in the country since 2010 and has been delivering diagnostics rubber stoppers, rubber stopper for vials, vaccines, plunger stoppers for prefilled syringes, etc to customers worldwide since 2013.|
“In 2015, the company had supplied products to 2.8 billion people worldwide. This year we are hopeful to deliver commercial supplies to 3 billion people globally,” said Rahul Dev, at Datwyler India. The new facility is specially designed to manufacture pharmaceutical rubber components in a fully integrated good manufacturing practice (GMP) environment using innovative automated processes, and conforming to the highest industry standards. Each zone has been meticulously designed and constructed in order to prevent bio-contamination and is equipped with material airlocks.
State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness. The new clean room also incorporates the latest generation of camera inspection techniques. The entire facility as a whole incorporates rational and lean production flows in accordance with the Six Sigma methodology. The most complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and syringe components.
Pfizer to invest $350 million in China
|Pfizer Inc, the United States, will invest $350 million to build a biotech center in China, the latest in a series of moves by pharma industry giants to set up shop in the world’s no. 2 drugs market with the aim of securing faster approvals for their products. The facility in eastern Hangzhou region – Pfizer’s first biotech center in Asia – is expected to be completed by 2018. Global “Big Pharma” is increasingly looking for smart ways to tap China’s healthcare market, estimated by consultancy IMS Health to be worth around $185 billion by 2018.|
From investing in China facilities to acquisitions, licensing deals and joint ventures, the aim is to seek an edge in dealings with domestic regulators and government. Pfizer said it would “work closely” with local regulators to bring the drugs “to market as soon as possible”. The center will mostly on biologic drugs – made from living micro-organisms rather than chemically synthesized – and lower-cost ‘biosimilars’, of generic versions of biologics. Pharmaceutical executives have long complained about the slow process of getting drugs to market in China, while others have run up against regulatory roadblocks.
Philippines launches mass dengue vaccination
|The Philippines launched the first public immunization program for dengue fever, seeking to administer to a million schoolchildren the world’s first licensed vaccine against a mosquito-borne disease that the World Health Organization (WHO) estimates infects 390 million people a year globally. Hundreds of 4th-graders at a public school in Marikina city were given the first of 3 shots of Dengvaxia. Some of the pupils received their vaccination shot under the glare of cameras during a festive ceremony at a gymnasium festooned with multicolored bunting and preceded by songs and dances performed by the children.|
According to the Department of Health, the Philippines had the highest dengue incidence in the WHO’s Western Pacific region from 2013 to 2015, recording 200,415 cases last year. “We are the first country to introduce, adopt and implement the first-ever dengue vaccine through (the) public health system and under a public school setting,” said Health Secretary Janette Garin. The government is spending 3.5 billion pesos ($76 million) to administer the free vaccines, which it bought at a discounted cost of 3,000 pesos ($65) for three doses for each child. The vaccine is given as a three-dose series, with the doses coming six months apart.
4-minute malaria detection kit in India
|Becton, Dickinson and Co. (BD), the United States, will introduce a malaria detection method developed by Israel’s Sight Diagnostics Ltd (SightDX) in India, which will make a diagnosis in just in four minutes. Sight Diagnostics has developed a novel computer vision platform for blood analysis, the SightDX Parasight Malaria Detection Platform. Through this agreement, BD will market the Parasight Platform in India, adding to BD’s extensive infectious disease diagnostics portfolio. The SightDX platform uses combines innovative software algorithms, specialized optics and a quicker sample preparation method.|
The instrument automatically analyses the sample and provides a diagnostic result within four minutes. The device also provides information on the species of the infecting malarial parasites and information that may be used by clinicians to aid in determining the severity of the illness. “Our collaboration with Sight Diagnostics is aligned with our purpose of advancing the world of health by bringing technology solutions for malaria diagnosis to India,” said Varun Khanna, at BD India and South Asia.
A collaboration to advance peptide therapeutics
|Agency for Science, Technology and Research (A*STAR), Singapore, and Merck & Co., Inc., (MSD), the United States, have formed a 2-year collaboration aimed at improving cellular delivery of macrocyclic peptides, a class of molecules that can potentially access therapeutic strategies that have been refractory to traditional approaches. This collaboration aims to uncover the chemical and biophysical properties that influence peptide penetration into cells, as well as to explore the use of smart delivery systems that leverage natural cell entry mechanisms.|
The collaboration will combine MSD’s experience and expertise in drug discovery including medicinal chemistry, pharmacology, pharmacokinetics, and molecular modelling with A*STAR’s research capabilities in multiple areas such as protein peptide interactions, bioinformatics, chemistry and membrane trafficking to establish compound design principles that will help unlock the full therapeutic potential of macrocyclic peptides.
Chinaâ€™s first HPV human papillomavirus vaccine
|China has approved the sale of GSK’s Cervarix HPV vaccine as the first human papillomavirus (HPV) vaccine licensed for use in the country. The China Food and Drug Administration said the commercial launch of Cervarix is expected in early 2017. Cervarix is registered in China for use in girls and women aged 9-25 years with a three-dose schedule and can help protect the health of millions of women in China at risk of cervical cancer. HPV is the most common sexually transmitted infection and is transmitted through intimate skin-to-skin contact.|
A person can acquire HPV by having vaginal, anal or oral sex with someone who has the virus. It is most commonly spread during vaginal or anal sex. GSK China’s Cervarix was approved following a clinical trial conducted in China involving over 6,000 subjects who received Cervarix or a control and were followed for up to six years. The drug demonstrated a high efficacy and favorable benefit risk ratio in preventing certain oncogenic HPV-related cervical diseases, which is consistent with global data.
New biotherapeutic data processing software
|SCIEX, the United States, has launched BioPharmaView Software 2.0 for automated biotherapeutic data processing that simplifies and accelerates biologics characterization for comparability at a glance. The new software contributes to the SCIEX 360-degree innovative approach to characterization. For large molecule bioanalysis, the SCIEX BioBA Solution has also expanded to include the advanced QTRAP 6500+ system, with new options and programs to enhance scientists’ workflows, helping them move from samples to data, with confidence in biopharma.|
BioPharmaView Software 2.0 ensures major improvements in processing speed for both intact mass and peptide mapping workflows. It has the ability to process SWATH acquisition data, for complete high-resolution MS/MS data to be acquired and analyzed in a single run, so important peptide and PTM information is not missed. It enables automated drug-to-antibody ratio calculation for antibody-drug conjugates (ADCs) and automated post-translational modification (PTM) ratio calculations for quick view of unmodified/modified peptide ratios.
BioPharmaView Software 2.0 has the ability to easily define custom modifications, including proprietary linkers and drug conjugates and has powerful batch processing functions and automated flagging for simplified comparability assessments. The software release is a key component of SCIEX 360-degree innovations for biologics characterization, a full circle product portfolio, which leverages the SCIEX history of CE, CESI, MS and software solutions designed specifically for biotherapeutic analyses, to simplify and accelerate both routine and complex workflows.
Heart pump to cost one-third
|Frontier Lifeline, India, has tied up with Russian scientists to manufacture a low-cost mechanical heart pump that can serve as an alternative to a transplant or as a temporary measure before transplant. “The ‘Made in India’ device will be available at one-third the cost of existing devices – 30 lakh as against 90 lakh,” said Dr. KM Cherian, at Frontier Lifeline. The device, called Left Ventricular Assisted Device (LVAD), can be surgically implanted to help the heart pump more blood with less work.|
It takes blood from the left ventricle and moves it to the aorta, which then delivers oxygen-rich blood throughout the body. The total cost of the two imported brands – from the US and Germany – including the surgery typically crosses 1.25 crore. “In the US, more than one lakh people have been using the device. The need is large in India but many patients die because they can’t use this expensive device. We can’t afford to have a backup if one device fails because the cost of the backup should be borne either by the patient or the hospital,” he said.
Serumâ€™s rabies vaccine gets marketing nod
|Serum Institute of India has got the market authorisation by the Central Drugs Standard Control Organisation (CDSCO) for its new rabies vaccine. “Our vaccine has not yet been launched, but it is likely to be in the first quarter of 2017,” said Adar Poonawala, at Serum Institute of India. The clinical trials conducted on this vaccine were for both the routes – intradermal (applied within layers for skin) as well as intramuscular (administered directly to muscle). The World Health Organisation (WHO) in 2010 had recommended the intradermal route, as the number of grams of vaccine consumed this way is significantly less, reducing the price by at least 60%.|
The institute has shown in this trial that the vaccine works with the same efficacy under both, intradermal and intramuscular route. This would offer substantial reduction in the administration cost of rabies vaccine in public hospitals,” said Poonawala. The prices of rabies vaccine are controlled by the government and are around Rs 300 per dose at present. The company’s vaccine, if applied through skin, is expected to cost the patient just a tenth of the price of the muscular dose. So, if the intramuscular dose costs Rs 320, the dermal version would cost just Rs 32.
First bevacizumab biosimilar in India
|Reliance Life Sciences, India, has launched a biosimilar of Switzerland’s Roche Holding AG (RHHBY), blockbuster cancer therapy bevacizumab (Avastin) in India – marking a first for the treatment that has been part of a legal tussle and off-label use concerns in the country. The Drug Controller General of India (DCGI) had earlier approved a biosimilar of bevacizumab to treat colorectal cancer by the company. It will be marketed by Lupin under the name Bevacirel at a price level just shy of the original drug from Roche.|
The patented drug has multiple global cancer licenses, including for lung, kidney and ovarian tumors, and made over $6.6 billion last year – making it Roche’s second-biggest seller in 2015. These sales are why the company has been fighting hard against copycats. In May, Roche filed a lawsuit to block approval of a biosimilar of the same drug by Hetero Drugs, India, because of the use of language in the packaging label that draws on Roche’s own work.
Genome of ancient barley grains sequenced
|An international team of researchers has succeeded for the first time in sequencing the genome of Chalcolithic barley grains. This is the oldest plant genome to be reconstructed to date. The 6,000-year-old seeds were retrieved from Yoram Cave in the Judean Desert, close to the Dead Sea. Genetically, the prehistoric barley is very similar to present-day barley grown in the Southern Levant, supporting the existing hypothesis of barley domestication having occurred in the Upper Jordan Valley.|
Members of the research team are from the Leibniz Institute of Plant Genetics and Crop Plant Research (IPK), Germany; Bar-Ilan University; Hebrew University, Israel; the Max Planck Institute for the Science of Human History, Germany; and the University of Haifa, Israel; The James Hutton Institute, the United Kingdom; University of California, the United States; University of Minnesota, the United States; University of Tübingen, Germany.
The analyzed grains, together with tens of thousands of other plant remains, were retrieved during a systematic archaeological excavation headed by Uri Davidovich, from the Hebrew University of Jerusalem, and Nimrod Marom, from the University of Haifa. The archaeobotanical analysis was led by Ehud Weiss, of Bar-Ilan University. The cave is very difficult to access and was used only for a short time by humans, some 6,000 years ago, probably as ephemeral refuge.
Genome-editing â€˜toolboxâ€™ targets multiple genes
|A research team from Yale University, the United States, has designed a system to modify, or edit, multiple genes in the genome simultaneously, while also minimizing unintended effects. According to the researchers, the gene-editing “toolbox” provides a user-friendly solution that scientists can apply to research on cancer and other disciplines. The team first developed a strategy to make the genome-editing machinery “inducible” – able to be turned on and off. They used a drug to turn the machinery on just long enough to edit the genes.|
This approach allowed them to activate the machinery as needed and for a limited amount of time, reducing off-target effects. “Their gene-editing system also contained a fluorescent marker so the researchers could track whether the editing enzyme was turned on or off in cells,” said Yan, at Yale. The next step was to make the process of gene editing less complex and time-consuming than previous systems. To target multiple genes simultaneously, the research team developed a simple strategy to put multiple targeting sequences in one step.
Each targeting sequence allows the editing machinery to recognize one gene. With the combined gene-editing strategies – the toolbox – the researchers focused on a group of three cancer-related genes. In experiments using both cultured cells and animal models, they simultaneously deleted all three genes. In addition to its application as a stand-alone system, the toolbox could be combined with other techniques to improve gene editing in biomedical research and other fields.
Genomic signatures of adaptation
|A new study led by a geneticist from Kansas State University (KSU), the United States, has shown that genomic signatures of adaptation in crop plants can help predict how crop varieties respond to stress from their environments. “It is the first study to document that these genomic signatures of adaptation can help identify plants that will do well under certain stresses, such drought or toxic soils,” said Geoff Morris, KSU. Researchers conducted the study with sorghum, one of the oldest and most widely grown cereal grain crops in the world.|
Sorghum is grown in Africa and Asia as well as in some of the world’s harshest crop-growing regions. More than 43,000 sorghum varieties around the world have been collected and stored in crop gene banks, which are centers that serve as repositories for crop diversity. Sampling from the crop gene banks, Morris and colleagues at Cornell University and the International Crops Research Institute for Semi-Arid Tropics (ICRISAT), took “snapshots” of genetic information in the genomes of about 2,000 sorghum varieties.
Because each sorghum variety was from a particular known location in an African or Indian village, the researchers were able to tie the genetic differences of each variety to its survival in a particular environment. Researchers were able to map each plant variety’s “genomic signature” of environmental adaptation. This signature reflects how different plant varieties from around the world have adapted to stressors in their environment, such as drought and toxic metals in the soil.
Immune genes linked to brain cancer death risk
|Researchers from First Hospital of China Medical University, China, have identified a set of 8 immune system genes that may play a role in how long people can live after developing a common type of brain cancer. People with fast-growing glioblastoma multiforme, or tumor of the glial cells in the brain, live an average of less than two years, even after treatment with surgery, radiation and chemotherapy. “We’ve had luck with other types of cancer in removing the brakes on the immune system to allow it to fight the tumors, but this has not been the case with glioblastoma,” said study author Dr. Wu Anhua.|
Researchers investigated tissue samples from 297 people with brain tumors. Of these, 127 had glioblastoma and 170 had a lower grade glioma, which is also a tumor of glial cells, but less aggressive than glioblastoma. Researchers analyzed the 322 immune-related genes through genome sequencing. Of the 322 genes analyzed, 8 genes played a role in glioblastoma. Three of the genes were protective against glioblastoma, while 5 increased the risk of earlier death. An 8-gene-based risk signature was established for risk stratification: people who were identified as high-risk cases were more likely to die earlier than people with low risk.
The 8-gene signature was also compatible for people with lower grade glioma. People in the high-risk group lived an average of 348 days after diagnosis, compared to 493 days for the low-risk group. They also were nearly twice as likely to have a shorter length of time between diagnosis and the first sign that the tumor was getting worse. The high-risk group had 242 days before the disease got worse, compared to 369 days for the low-risk group. The results were the same after researchers adjusted for other factors that could affect how long people lived, such as what type of treatment they received.
Genetic connections among human traits
|In a new study, researchers from New York Genome Center (NYGC), the United States, combined data from more than 16 GWASs as well as from 23andMe’s database to discover novel gene-trait associations. But the researchers also added an extra layer of analysis, pooling 42 seemingly different traits – including diseases – to uncover phenotypes that may be causally linked. “Our idea was to try to gather up all the traits that have been studied in large genetic studies and see if there is shared biology between these different traits that seem unrelated,” said Joseph Pickrell, at NYGC.|
The study revealed 341 loci associated with multiple traits. Several of these genetic variants were linked to later onset of menarche in girls, a later age of voice drop in boys, lower body mass index, increased height in both men and women, and a reduced risk of male-pattern baldness. “Reproductive timing is the kind of thing that should evolve with changes in our environment, and it’s exciting to see that these reproductive timing traits are genetically correlated across the sexes,” said Rockman. The researchers also found a variant of a heavy metal transporter that is associated with Parkinson’s disease, schizophrenia, and height.
Intellectual disability syndrome
|Scientists at the Wellcome Trust Sanger Institute, the United Kingdom, and Max Planck Institute for Psycholinguistics, the Netherlands, have found a gene responsible for an intellectual disability disorder and proven how it works. The research details the role of a gene called BCL11A in a new intellectual disability syndrome. The study showed that if one of a person’s two copies of the BCL11A gene is abnormal, or mutated, then they will have the newly described intellectual disability.|
The team used human cells and a mouse model to show that the body needs two healthy copies of BCL11A to make enough of the BCL11A protein for brain cells to develop normally and work at capacity. The Sanger Institute’s research programme, has found many new genes associated with intellectual disability. However, relatively little is known about how these genes work because each genetic cause is so rare. By exploring the mechanism in mice, they have been able to show for the first time the impact of these genes on human development.
A team led by Dr Darren Logan and Professor Simon Fisher worked with nine patients, from the UK and abroad, who have an intellectual disability. They found these people share the same genetic profile and symptoms that they now define as a new clinical syndrome. Each person also had the same unusual blood profile which could be used to help diagnose patients in the future. The results have been published in the American Journal of Human Genetics.
Protein that may help in killing HIV virus
|Researchers from Blood Systems Research Institute (BSRI), the United States, have claimed that they have identified a protein that has the potential to spot and kill human immunodeficiency virus (HIV). The research claims that this protein has the potential to force the virus out of hiding and poison them on their way out, which can in turn lead to potential treatments for the deadly disease. The findings showed that galectin-9 – a human sugar-binding protein – reactivates latent HIV viruses and renders these infected cells visible to the immune system, in a process called the “shock and kill” HIV eradication strategy.|
Galectin-9 works by manipulating the sugars on the surface of HIV-infected cells to deliver the signals that force latent HIV out of hiding. “Galectin-9 binds to certain classes of sugars on the surface of cells to start a chain reaction that forces HIV out of hiding. This sugar coating may hold the key to new therapeutics that can be harnessed to cure HIV and possibly a range of other infectious diseases,” said Mohamed Abdel-Mohsen, at BSRI. In addition, galectin-9 was also found to strongly increase the levels of an antiviral protein called “APOBEC3G” – a lethal mutagen that destroys the genetic code of viruses including HIV, in infected cells.
Protein insights to cure heart disease
|Research led by The Australian National University (ANU) has uncovered new insights into how the human genome gets through the daily grind with the help of RNA-binding proteins, in a discovery which could ultimately lead to a cure for heart disease. “The finding opens new avenues of research into RNAs – short-lived copies of the genetic information stored in DNA,” said Thomas Preiss, at ANU.|
“In studying how RNA-protein interactions govern genome function in the heart, we saw potential for both the generation of knowledge and ultimately the development of new therapy. So we endeavoured to establish a collection of RNA-binding proteins that are active in heart muscle cells,” Professor Preiss said. Heart disease is a leading cause of death in Australia with an average one death due to heart disease in Australia every 27 minutes.
All cellular life uses DNA to store genetic information and to pass it on through the generations. But the information is useless unless it is copied into the chemically similar but more versatile nucleic acid molecules called RNA. RNA carries the code for making proteins, the bricks and mortar of life, but it also has noncoding regulatory roles that are particularly important in architecturally complex beings such as humans.
Green fluorescent protein
|Scientists at the Korea Advanced Institute of Science and Technology (KAIST), Republic of Korea, has developed a set of green fluorescent protein (GFP) assemblies with relatively simple, well-defined structures that can be powerful scaffolds for assembling other proteins. GFP is a fluorescent protein composed of 238 amino acid residues. It is commonly found in some fluorescing marine animals such as jellyfish. Because of its fluorescent properties, making it easy to see, it has been widely used in research.|
The team formed the scaffold by taking advantage of the fact that two different GFP units with specific chains of GFP amino acids can be spontaneously linked in a bacterial cell. A GFP monomer was designed to have these two linking units. This monomer then self-assembles with other GFP monomers to form polymers. The researchers discovered that each polymer was organized in a polygonal shape resembling a windmill with 2 to 10 blades, each blade representing a GFP monomer. A four-bladed polymer, for example, is composed of four monomers linked together to form a tetramer.
The team was able to separate the polymers based on their sizes. Proteins were then genetically linked to the free ends of each GFP monomer “blade.” The team also showed that they could block one link in the polymer “windmill” to create linear chains of GFP units, up to 15 units in length. The researchers were able to link proteins to this new GFP open structure, demonstrating the ability to assemble proteins with varied spatial organisations. Finally, the team successfully linked antibodies to their polygon and linear chain scaffolds; something that could, in the future, facilitate antibody delivery to cells.
New method to model protein interactions
|A team of international scientists led by researchers at Stony Brook University (SUNY), the United States, have created an ultra-fast way to model protein interactions. The method may help pave the way to design drugs that prevent problematic protein interactions that lead to disease. “The problem considered is given three dimensional structures of two individual proteins to predict how these protein interact with each other,” said Dima Kozakov, at SUNY. The findings are published in PNAS.|
In the paper titled “Protein-protein docking by fast generalized Fourier transforms on 5D rotational manifolds,” the authors explained a new algorithm used to create ultra-fast approach to modeling protein interactions. They discovered that the method runs 10 to 100 times faster than previous state-of-the-art methods, without compromising accuracy. The researchers used something called fast Manifold Fourier transform (FMFT) that help speed the calculations, enabling them to sample a large number of putative protein-protein complex conformations.
Genome engineering of quantifiable protein tags
|Professor Sven Eyckerman and colleagues at VIB/UGent, Belgium, have developed a set of universal protein tags that warrant protein quantification via targeted proteomics techniques. The development and applications of these new tags – named Proteotypic peptides for Quantification by SRM (PQS). To bring this idea into reality, the lab teamed up with Lennart Martens and Kris Gevaert at VIB/UGent. The scientists mined the proteome of the hyperthermophile Pyrococcus furiosus for unique sequences with optimal mass spectrometry characteristics.|
“The rather extreme habitat of this archaebacterium results in a truly unique proteome, which provided us with a great source for unique peptides”, said Martens. For the peptides to be universally applicable in a wide range of model organisms, the team specifically looked for peptides proteotypic for all eukaryotes and all E. coli strains. Two ideal peptides were retained and found suitable for direct sensitive detection and quantification in complex lysates. “Before, I needed to setup an SRM assay for each protein of interest, which was labor intensive and often had a low success rate”, explained An Staes, at VIB/UGent.
To introduce the quantifiable tags into the genome of human cells, the scientists put new recruits of the genome engineering toolbox into action. “With the CRISPR/Cas9 system we could efficiently tag endogenous proteins in mammalian cell lines cultures, providing a universal quantitative read-out system for the tagged proteins. This adds a powerful novel aspect to genome editing. An accurate and sensitive quantification of an endogenous protein is now possible, either directly or after purification of the protein within a protein complex”, commented Eyckerman.
Proteins work together to turn on T cells
|In a new study, scientists at California Institute of Technology (Caltech), the United States, investigated the switch for T cells, which are immune cells produced in the thymus that destroy virus-infected cells and cancers. The researchers wanted to know how cells make the choice to become T cells. “We already know which genetic switch directs cells to commit to becoming T cells, but we wanted to figure out what enables that switch to be turned on,” said Hao Yuan Kueh, at Caltech.|
The study found that a group of four proteins, specifically DNA-binding proteins known as transcription factors, work in a multi-tiered fashion to control the T-cell genetic switch in a series of steps. This was a surprise because transcription factors are widely assumed to work in a simultaneous, all-at-once fashion when collaborating to regulate genes. The results may ultimately allow doctors to boost a person’s T-cell population. This has potential applications in fighting various diseases, including AIDS, which infects mature T cells.
The authors reported that a key to their finding was the ability to image live cells in real-time. They genetically engineered mouse cells so that a gene called Bcl11b – the key switch for T cells – would express a fluorescent protein in addition to its own Bcl11b protein. This caused the mouse cells to glow when the Bcl11b gene was turn on. By monitoring how different transcription factors, or proteins, affected the activation of this genetic switch in individual cells, the researchers were able to isolate the distinct roles of the proteins.
Scientists grow mini human brains
|Scientists at A*STAR’s Genome Institute of Singapore (GIS) have made a big leap on research on the ‘mini-brain’. These advanced mini versions of the human midbrain will help researchers develop treatments and conduct other studies into Parkinson’s Disease (PD) and ageing-related brain diseases. These mini midbrain versions are three-dimensional miniature tissues that are grown in the laboratory and they have certain properties of specific parts of the human brains.|
This is the first time that the black pigment neuromelanin has been detected in an organoid model. The study also revealed functionally active dopaminergic neurons. Jointly led by Prof. Ng Huck Hui from GIS and Assistant Prof Shawn Je from Duke-NUS Medical School, Singapore, this collaborative research between GIS, Duke-NUS, and the National Neuroscience Institute (NNI), Singapore, is funded by the National Medical Research Council’s Translational Clinical Research (TCR) Programme In Parkinson’s disease (PD) and A*STAR.
“It is remarkable that our midbrain organoids mimic human midbrain development. The cells divide, cluster together in layers, and become electrically and chemically active in three-dimensional environment like our brain. Now we can really test how these mini brains react to existing or newly developed drugs before treating patients, which will be a game changer for drug development,” said Shawn Je.
New bio-ink for 3D printing with stem cells
|Scientists from the University of Bristol, the United Kingdom, have developed a new stem cell-containing bio-ink that allows 3D printing of complex living tissues that may be used for surgical implants. The bio-ink contains two different polymer components: a natural polymer extracted from seaweed, and a sacrificial synthetic polymer used in the medical industry, and both had a role to play.|
The synthetic polymer causes the bio-ink to change from liquid to solid when the temperature is raised, and the seaweed polymer provides structural support when the cell nutrients are introduced. “Designing the new bio-ink was extremely challenging. You need a material that is printable, strong enough to maintain its shape when immersed in nutrients, and that is not harmful to the cells. We managed to do this, but there was a lot of trial and error before we cracked the final formulation,” said Adam Perriman from the University of Bristol.
The team was able to differentiate the stem cells into osteoblasts – a cell that secretes the substance of bone – and chondrocytes, cells that have secreted the matrix of cartilage and become embedded in it, to engineer 3D printed tissue structures over five weeks, including a full-size tracheal cartilage ring. “What was really astonishing for us was when the cell nutrients were introduced, the synthetic polymer was completely expelled from the 3D structure, leaving only the stem cells and the natural seaweed polymer,” said Mr. Perriman.
Scientists develop rheumatoid arthritis drug
|BIOCAD, Russia, has developed innovative medicine for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other autoimmune diseases. According to scientists forecast, the new drug candidate (BCD-121) can increase the efficacy of treatment of RA up to 20% in comparison to currently available therapy regimens. BIOCAD has invested more than 155 mln. RUB., in very early development stages of BCD-121. As for, there is no registered drug in the world with the same mechanism of action.|
Modern medicines that are available for RA treatment are able to inhibit only one inflammatory protein or its receptor. BIOCAD has developed the novel molecule, which can block two proteins simultaneously. BCD-121 is so called bispecific monoclonal antibody with superior functional properties and convenient subcutaneous form. “Bispecific antibodies have synergetic effects that are likely to result in higher efficacy in comparison to monospecific antibodies that are targeting only one protein,” said Roman Ivanov, at BIOCAD.
Unfortunately, over the time one third of RA patients become resistant to monospecific drugs, which means that medicine blocking only one inflammatory protein, does not work anymore. According to scientists forecast, the novel molecule BCD-121 will be a solution for such resistant patients. Only few other companies develop similar bispecific molecules. BCD-121 will enter the phase I clinical trial already this year. The development program for the novel molecule will last until the year 2021.
Stem cells turned into nerve cells
|For the first time in India, the stem cell research group at the Sri Ramachandra University (SRU), Chennai, India, has isolated stem cells from human gum tissue and turned them into nerve cells. Currently, these stem cells are being tried in spinal cord injury in animals at the SRU. The team of researchers headed by Dr. R. Suresh and research scholars S. Rajasekharan and M.G. Dinesh, isolated stem cells from human gum tissue, placed them in hydrogel scaffold, turning them into nerve cells.|
Researchers at SRU, within last one year, grew stem cells after obtaining gum tissue from humans. After certain period of time they were able to separate stem cells from gum tissue. By using specific identification markers they confirmed the cells as stem cells. “At this juncture we obtained hydrogel scaffold from Dr. A. Gnanamani, and S.T.K. Raja, at CLRI, Chennai, and grew the gum stem cells on the scaffold. With the addition of certain proteins, we were able to make the stem cells turn into nerve cells,” the doctor added.
New diagnosis and treatment for lung cancer
|In a study conducted by a team of researchers jointly led by Dr. Lim Bing and Dr. Tam Wai Leong from A*STAR’s Genome Institute of Singapore (GIS) found fresh insight into understanding therapy resistance in lung cancer and unveiled new avenues to monitor and treat the disease more effectively. The team discovered a class of small RNA molecules, known as oncomiRs, which are responsible for fueling lung cancer.|
Their findings revealed that rare cancer stem cells, which are mainly driven by the oncomiRs, within tumors are resistant to conventional therapies. This makes the stem cells the major culprits for relapse in lung cancer patients. The researchers found that administering therapies that obliterate the oncomiRs opens up possibilities to kill the cancer stem cells. They applied a new class of therapeutics, known as locked nucleic acid (LNA), which would work against oncomiRs in the cancer stem cells.
The method successfully obliterated human lung tumors grown in mice models, and the team is now working to develop this into a drug that can be administered into humans by collaborating with pharmaceutical companies. Researchers also found that oncomiRs could be detected in patients’ blood through liquid biopsies, which is minimally invasive and less time consuming compared to tissue biopsies. Tracking the oncomiR levels real-time in the blood enables the researchers to monitor their response and potentially predict any recurrence and metastasis.
Vaccine to prevent Alzheimerâ€™s disease
|Experts at Flinders University, Australia, have made a “breakthrough discovery” which could bring about the world’s first dementia vaccine. The vaccine could be used to prevent and even reverse the early stages of Alzheimer’s, the most common form of dementia. The successful vaccine formula targets abnormal beta-amyloid and tau proteins that trigger Alzheimer’s disease. If human clinical trials are successful, a vaccine could be developed in as soon as 3 to 5 years.|
“The breakthrough was so significant, there was confidence it would eventually be used as a preventive vaccine, much like a flu shot, that could eradicate dementia. You could actually give it to everyone, say when they turn 50, a bit like we give all high-risk groups a flu shot, and thereby stop it in its tracks. You can immunise for it before it even starts,” said Professor Nikolai Petrovsky, at Flinders University.
There was also potential to use it to reverse some of the late symptoms of the disease, he said. Clinical trials in humans were expected in the next couple of years, he said. According to Alzheimer’s Australia there are more than 353,800 Australians living with dementia and without a medical breakthrough that number is expected to rise to almost 900,000 by 2050.
GM crops do not add to human health risks
|In a report released by the National Academies of Sciences, Engineering, and Medicine (The Academies) has showed no increase in health risks due to the consumption of genetically modified (GM) food. The group, however, noted that expert scientific bodies do not agree about the cancer-causing potential of glyphosate, an herbicide that’s often paired with genetically engineered crops. Although the use of genetically modified organisms (GMOs), has led to increases in weed and pest resistance and called for incentives and regulations to push farmers toward practices to delay the evolution of resistance in weeds and pests.|
The report advocated for similar regulatory treatment of plants whose genes have been altered in any way — either through genetic engineering or conventional breeding techniques. The U.S. Department of Agriculture (DOA) and the Environmental Protection Agency (EPA) partially decide which plants to regulate based on the process by which their genes were altered, and new methods of genetic manipulation may fall outside existing regulatory regimes.
Any genetic alteration has the potential for unintended consequences, and the product, not the process, should be the driver behind regulatory review. GM crops were widely adopted in U.S. agriculture in the 1990s, mainly by incorporating genes resistant to pests and herbicides. Creve Coeur-based Monsanto was one of the early developers of genetically modified crops, engineering soybeans and corn to be resistant to glyphosate, sold under the brand Roundup.
Tomatoes that last longer and still taste good
|A research led by Professor Graham Seymour, at The University of Nottingham, the United Kingdom, in collaboration with Professor Paul Fraser at Royal Holloway, University of London, the United Kingdom, has identified a gene that encodes an enzyme which plays a crucial role in controlling softening of the tomato fruit. The results, could pave the way for new varieties of better tasting tomatoes with improved postharvest life through conventional plant breeding. The results have been published in the academic journal Nature Biotechnology.|
It was funded by the Biotechnology and Biological Sciences Research Council (BBSRC) and Syngenta Seeds, a supplier of vegetable seeds to the global market. The question of how the tomato fruit disassembles its cell walls and softens during ripening has perplexed researchers for over two decades. This research has found the key to uncoupling softening from the other aspects of fruit quality. Professor Seymour and his team have identified a gene that encodes a pectate lyase which normally degrades the pectin in the tomato cell walls during ripening.
“In laboratory experiments we have demonstrated that if this gene is turned off, the fruit soften much more slowly, but still show normal changes in colour and the accumulation of taste compounds such as acids, sugars and aroma volatiles. Natural variation exists in the levels of pectate lyase gene expression in wild relatives of cultivated tomato and these can be used for conventional breeding purposes. This discovery can provide a means to refine the control of fruit softening in modern tomato cultivars,” said Seymour.
Novel repair system discovered in algae
|Research specialists Stephen Campbell and Professor David Stern at the Boyce Thompson Institute, the United States, have discovered a new way of fixing inactive proteins in algae, which uses chloroplast extracts and light to release an interrupting sequence from a protein. This repair system may have applications in agriculture and biotechnology because it could potentially be harnessed to enable proteins to become active only in the light. Campbell discovered this new repair system while purifying a protein from the chloroplasts of C. reinhardtii that can cut RNA.|
Upon sequencing the protein, he identified it as RB47, a protein that was not known to have any RNA-cleaving ability. Campbell noticed that the middle of the protein was missing. When he compared the protein sequence to its corresponding gene sequence, the protein was much shorter than expected. Upon further study, Campbell found that he could detect a long version of the protein that contained an insertion and a short version that didn’t. The cells make both versions when grown in the light or the dark, but only the short version can cleave RNA.
The long version of the protein could be converted into the short one by mixing it in a test tube with chloroplasts from cells grown in the light and by illuminating the reaction. This process removed the interrupting insertion and restored the RNA-cutting activity of the protein. It is likely that the chloroplast maintains the machinery necessary to remove the sequence so that it can restore functionality to the protein. This new type of repair system provides intriguing possibilities for biotech applications.
New gene to expand power of photosynthesis
|A research team led by Donald A. Bryant, at Pennsylvania State University (Penn State), the United States, has identified a new gene to expand light harvesting in photosynthesis into the far-red-light spectrum that provides clues to the development of oxygen-producing photosynthesis, an evolutionary advance that changed the history of life on Earth. “Knowledge of how photosynthesis evolved could empower scientists to design better ways to use light energy for the benefit of mankind,” said Bryant.|
This discovery could enable scientists to engineer crop plants that more efficiently harness the energy of the Sun. The researchers identified the gene that converts chlorophyll a – the most abundant light-absorbing pigment used by plants and other organisms that harness energy through photosynthesis – into chlorophyll f – a type of chlorophyll that absorbs light in the far-red range of the light spectrum. There are several different types of chlorophyll, each tuned to absorb light in different wavelengths. Most organisms that get their energy from photosynthesis use light in the visible range, wavelengths of about 400 to 700 nanometers.
The gene the researchers identified encodes an enzyme that is distantly related to one of the main components of the protein machinery used in oxygen-producing photosynthesis. The researchers showed that the conversion of chlorophyll a to chlorophyll f requires only this one enzyme in a simple system that could represent an early intermediate stage in the evolution of photosynthesis. Understanding the mechanism by which the enzyme functions could provide clues that enable scientists to design better ways to use light energy.
Researchers study colon cancer cells
|According to a study done by researchers at Saint Louis University (SLU), the United States, a combination of two plant compounds that have medicinal properties – curcumin and silymarin – holds promise in treating colon cancer. “The researchers studied a line of colon cancer cells in a laboratory model. They found treating the cells initially with curcumin, then with silymarin was more effective in fighting cancer than treating the cells with either phytochemical alone,” said Uthayashanker Ezekiel, at SLU.|
“The combination of phytochemicals inhibited colon cancer cells from multiplying and spreading. In addition, when the colon cancer cells were pre-exposed to curcumin and then treated with silymarin, the cells underwent a high amount of cell death. Phytochemicals may offer alternate therapeutic approaches to cancer treatments and avoid toxicity problems and side effects that chemotherapy can cause,” added Ezekiel.
Ezekiel noted the research is a preliminary cell study, with more research ahead before scientists know if the compounds are an effective treatment for people who have colon cancer. He saw promise in using the phytochemicals to help prevent colon cancer, which frequently is caused by lifestyle factors, such as diet.
New insight into how plants make cellulose
|Researchers at University of Dundee (Dundee), the United Kingdom, and University of Manchester (UoM), the United Kingdom, has found out more about one of the most abundant biological substances on the planet. Dr. Piers Hemsley at Dundee and Professor Simon Turner at UoM have been studying cellulose – the major structural component in plants.|
Dr. Hemsley and Professor Turner identified an important new process in cellulose synthesis called S-acylation. S-acylation involves adding fatty acids to proteins to change the proteins function. They found that when the proteins that create cellulose, known as the cellulose synthase complex, were not S-acylated, plants were no longer able to make cellulose.
This makes S-acylation an extremely important part of the cellulose synthesis process. “This work will help us to understand how the cellulose synthase complex works, how plants form cellulose and how they lay it down in the patterns that provide strength and structure to the plant,” said Dr. Hemsley. The results have been published in the journal Science.
Techniques in Genetic Engineering
|The book introduces some common genetic engineering techniques and focuses on how to approach different real-life problems using a combination of these key issues. Although not an exhaustive review of these techniques, basic information includes core concepts such as DNA, RNA, protein, genes, and genomes. It is assumed that the reader has background on these key issues.|
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Plant Biology and Biotechnology
|This book is devoted to various aspects of plant biology and crop improvement. The chapters provide the molecular biological basis for the regulation of morphogenesis of the form of plants and their organs, involving control at the cellular and tissue levels. Details on biodiversity, the basic raw material for biotechnology are discussed, in which emphasis is placed on the genetic, species and ecosystem diversities and their conservation.|
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Corynebacterium glutamicum: From Systems Biology to Biotechnological Applications
|This book provides a comprehensive overview of current knowledge and research on C. glutamicum systems biology and biotechnological applications. The topics covered include: proteomics; flux analysis technology for metabolic analysis; metabolic engineering for alternative carbon source utilization; manipulation of nitrogen metabolism; transport, degradation and assimilation of aromatic compounds and their regulation, etc.|
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