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Highlights l India and Denmark to begin joint research projects l Sanofi to launch new drugs in India l Scientists create genetic design of inner ear cell l Researchers develop proteins tweaking technique l Hair stem cells to repair damaged nerves l China to improve biotech approval process ISSN 0971-5622 Vol. 1 No. 128 l Oct - Dec 2015 VATIS UPDATE Biotechnology Apprise yourself with the latest technological innovations BCIL

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Page 1: Biotechnology - Biotech Consortium India Limitedbcil.nic.in/files/Publication/VATIS_October-December2015.pdf · l India and Denmark to begin joint research projects ... Apprise yourself

Highlightsl India and Denmark to begin joint research projects

lSanofi to launch new drugs in India

l Scientists create genetic design of inner ear cell

l Researchers develop proteins tweaking technique

l Hair stem cells to repair damaged nerves

l China to improve biotech approval process

ISSN 0971-5622Vol. 1 No. 128 l Oct - Dec 2015

VATIS UPDATE

Biotechnology

Apprise yourself with the latest technological innovations

BCIL

Page 2: Biotechnology - Biotech Consortium India Limitedbcil.nic.in/files/Publication/VATIS_October-December2015.pdf · l India and Denmark to begin joint research projects ... Apprise yourself

The Asian and Pacific Centre for Transfer of Technology (APCTT), a subsidiary body of ESCAP, was established on 16 July 1977 with the objectives: to assist the members and associate members of ESCAP through strengthening their capabilities to develop and manage national innovation systems; develop, transfer, adapt and apply technology; improve the terms of transfer of technology; and identify and promote the development and transfer of technologies relevant to the region.

The Centre will achieve the above objectives by undertaking such functions as:

n Research and analysis of trends, conditions and opportunities;n Advisory services;n Dissemination of information and good practices;n Networking and partnership with international organizations and key stakeholders; andn Training of national personnel, particularly national scientists and policy analysts.

The shaded areas of the map indicate ESCAP members and associate members

Cover PhotoPeptides harvested from rice proteins are sorted by size using a special filtration technique.

(Credit: Fraunhofer UMSICHT, Germany)

Page 3: Biotechnology - Biotech Consortium India Limitedbcil.nic.in/files/Publication/VATIS_October-December2015.pdf · l India and Denmark to begin joint research projects ... Apprise yourself

VATIS* Update Biotechnology

is published 4 times a year to keep the readers up-to-date of most of the relevant and latest technological

developments and events in the field of Biotechnology. The update is tailored

to policy makers, industries and technology transfer intermediaries.

Website: http://www.techmonitor.net

Editorial BoardAPCTT

Mr. Nanjundappa Srinivasan Dr. Satyabrata Sahu

Dr. Krishnan SrinivasaraghavanBCIL

Dr. Purnima Sharma Ms. Anita Sharma

ASIAN AND PACIFIC CENTRE FOR TRANSFER OF TECHNOLOGY

Adjoining Technology Bhawan Qutab Institutional Area

Post Box No. 4575 New Delhi 110 016, India Tel: (91) (11) 3097 3700

Fax: (91) (11) 2685 6274 E-mail: [email protected]

Website: http://www.apctt.org

BIOTECH CONSORTIUM INDIA LTD. 5th Floor, Anuvrat Bhawan,

210, Deen Dayal Upadhyaya Marg, New Delhi 110 002, India

Tel: (91) (11) 2321 9064-67 Fax: (91) (11) 2321 9063

E-mail: [email protected] Website: http://www.bcil.nic.in

The designation employed and the presentation of material in the

publication do no imply the endorsement of any product, process or

manufacturer by APCTT or BCIL.

This publication has been issued without formal editing

* Value Added Technology Information Services

CONTENTSVol. 1 No. 128 Oct–Dec 2015

IN THE NEWS 4

¨ Pollution control inspections may revise in India ̈ India and Denmark to begin joint research projects ̈ National biodiversity project in India ̈ Researchers to develop new low-cost heart valve ̈ Fast-track nod for dengue drug ̈ Virtual centre for bioenergy ̈ China to mass produce Ebola vaccine ̈ India receives proposal for GM mustard plantation ̈ Global endoscopy market value to rise by $9.7 bn ̈ Sinovac to supply flu vaccine in China ̈ Researchers set to exploit supercomputer in Japan

MARKET NEWS 8

¨ Novartis launches first U.S. biosimilar drug ̈ IAVI, CureVac partner to develop AIDS vaccine ̈ GSK may get EU nod for new biotech asthma drug ̈ Sanofi to launch new drugs in India ̈ ICAR signs a strategic tie up with SABC

GENOMICS 10

¨ Scientists create genetic design of inner ear cell ̈ New technique to make dogs more stronger ̈ Researchers uncover a novel link ̈ Scientists predict the human genome using evolution ̈ New way to edit genes

PROTEOMICS 12

¨ Proteomics marks traction on a global scale ̈ Scientists discover new RNA molecules ̈ Researchers develop proteins tweaking technique ̈ SCIEX to develop new R&D centre ̈ New protein manufacturing process unveiled

MEDICAL BIOTECH 14

¨ New discovery to develop antibiotics ̈ Hair stem cells to repair damaged nerves ̈ New vaccine against chronic hepatitis B ̈ Researchers use DNA to engineer tiny human tissue ̈ New therapeutic avenues for treating TB ̈ First trial of umbilical cord stem cells to cure HIV

AGRI BIOTECH 16

¨ China to improve biotech approval process ̈ First GMO corn crops in Viet Nam ̈ GM plants could eliminate food poisoning ̈ USAID grant to improve po-tato production ̈ Scientists discover new species of wild mushrooms

RECENT PUBLICATIONS 18

TECH EVENTS 18

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4 VATIS UPDATE: Biotechnology n Oct-Dec 2015

Pollution control inspections may revise in IndiaThe government of India may consider the possibility of revis-ing pollution control inspections of production plants to a once in five-year format from the cur-rent the practice of frequent and surprise checks. “The proposal is part of the government’s efforts to ensure a favourable environment to attract investments in India and restore the confidence of global investors in the pharma-biotech manufacturing sector,” said Dr. V.K. Subburaj, at department of pharmaceuticals (DoP). Ministry of environment & forests (MoEF), which has listed industries under red, orange and green categories based on the heavy pollutant dis-charges includes fermentation and pharmaceuticals under its Central Action Plan. The simplification of central and state pollution control board in-spections to once in five years is expected to provide much ease of operation for the pharma and biotechnology sectors which come under the red category industries identified by MoEF. There are several grievances and criticisms about the pharma and biotech manufacturing plants as they are known to increase pollution for residential areas coming up in the vicinity of industrial zones ear-marked for only manufacturing op-erations. Now pharma and biotech units view this as the way forward to remain constantly compliant to the norms. The Central Pollution Control Board (CPCB) is now as-sessing the norms and is propos-ing a revision. A revised concept note to this effect is underway.

“We hope the proposal will come through and it would be the best that could happen to the pharma

and bio-pharma industries. More-over it would indicate to the po-tential global investor that safe environment practices along with simplified pollution inspections norms are being put in place,” said Kiran Mazumdar-Shaw, MD Bio-con Limited, India. It is advisable to revise the pollution inspections from frequent and annual checks to a once in five-year format based on the risk assessment of ICH Q9 guidelines. It should not be done directly once in five years. In case of some major observations, then it is annual and for the less major observations then it is once in two years. Similarly, Medicines and Healthcare products Regulatory Agency (MHRA) sometimes audits once in three years.

Source: http://www.pharmabiz.com

India and Denmark to begin joint research projectsTo further develop and strengthen the Danish-Indian research coop-eration within health science bio-technology, India and Denmark will soon embark on strategic research projects within human health sci-ence biotechnology. Department of biotechnology (DBT), India and the Innovation Fund Den-mark (previously Danish Council for Strategic Research) are the implementing agencies for this research project.

The objective of this progamme, through the present joint strate-gic research programme, is to strengthen and intensify the re-search effort within the area of human health science biotechnol-ogy and to integrate the specific competencies of the Indo-Danish research groups involved. Further, for both countries it is of major im-portance to provide human health science biotechnology solutions

that accommodates the related challenges in a sustainable way.

The research will link basic bio-logical research and health and disease awareness with clinical research, including epidemiology. The research aims to develop more rapid and precise diagnostics and better prevention together with new, targeted, effective and personalized medical interventions and care. Both the DBT and the IFD have invited scientists from universities, research institutions and private companies in India and Denmark to apply for funding of joint Indo-Danish strategic research projects within the area of human health sci-ence biotechnology.

Source: http://www.pharmabiz.com

National biodiversity project in IndiaIn order to ensure compliance to Biological Diversity Act, 2002 and Rules, 2004, the Indian National Biodiversity Authority (NBA) has started implementation of the first national project with focus on ac-cess and benefit sharing (ABS) provisions in 5 states of the coun-try. The project is implemented in the states of Andhra Pradesh, Gujarat, West Bengal, Himachal Pradesh and Sikkim by the NBA in collaboration with the respective state biodiversity boards, United Nations Environment Programme (UNEP)-Division of Environmen-tal Law and Conventions (DELC), United Nations University – Insti-tute of Advanced Studies (UNU-IAS) and the United Nations De-velopment Programme (UNDP).

The project aims to develop stand-ardized economic valuation meth-ods for valuing biodiversity in the selected ecosystem, developing database on biological resources to tap ABS potential in project

IN THE NEWS

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VATIS UPDATE: Biotechnology n Oct-Dec 2015 5

states. It will also help in assessing and quantifying the economic val-ue of biological diversity present at local, state and national levels using appropriate methodologies, determining benefit sharing and in-forming national decision makers on prioritizing conservation action. This will also be instrumental in developing legal tools, methodolo-gies, guidelines and frameworks for ABS mechanism.

Implementation of the project also involves capacity building for stakeholders in decision-making process, piloting ABS agreements in project states, promotion and strengthening of biodiversity funds at national, state and local levels besides strategizing public aware-ness programmes and facilitating level playing for public, NGOs and private sector on ABS. Government of India has enacted Biological Di-versity Act (2002) and Rules (2004) for conservation of biological diver-sity, sustainable use of its compo-nents and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters connected there-with or incidental thereto.

Source: http://www.pharmabiz.com

Researchers to develop new low-cost heart valveResearchers from Colorado State University (CSU), the United States, and the Ohio State Uni-versity (OSU), the United States, and the PSG Institute of Medical Science and Research, India, will work together, to develop a low-cost prosthetic heart valve for In-dia. The research will get a grant for 2 years from the National In-stitutes of Health (NIH) in the US and Department of Biotechnology in India. The principal investiga-tors will be Dr. P. R. Murugesan

of PSG Hospitals and Dr. Lakshmi Prasad Dasi of CSU. They plan to develop a valve that is superior to the mechanical-tissue valves in use now. Plastic materials will be used to address problems asso-ciated with rheumatic heart valve disease, which is common in de-veloping nations.

“Patients who receive mechani-cal heart valves must remain on lifelong medication to prevent clot-ting of blood. These have their own side effects and complications. Bi-oprosthestic valves, usually made from animal tissue, are prone to hardening over time. They last only 10-15 years. The valve to be developed under this project will be made from flexible plastic materials containing hyaluronan, a chemical found in natural heart valve tissues. Its design will be op-timised for superior performance over a longer period without need-ing anticoagulation therapy,” said Dr. Dasi. The PSG Institute has already opened a new lab to con-duct pre-clinical studies in pigs and sheep in Coimbatore.

Source: http://www.newindianex-press.com

Fast-track nod for dengue drugAsia’s largest vaccine maker, Se-rum Institute of India, plans to file for fast-track approval to launch a dengue treatment in India, poten-tially becoming the first company globally to launch a drug for the mosquito-borne virus. Serum’s plans come as India battles soar-ing death rates from dengue and its capital New Delhi faces the worst outbreak of the virus in five years, exposing inadequate pub-lic health measures to combat the disease. Dengue is common in In-dia and cases generally peak in October, after the monsoon rains.

It is one of the biggest causes of hospitalization and death among children in India.

Serum bought exclusive rights from Visterra, the United States, to sell its innovative monoclonal an-tibody, VIS513, as a treatment for dengue in the Indian subcontinent in a deal worth up to $39 million. Visterra has tested the antibody on animals so far. “Once you inject this into a patient who has dengue, they should show a result within three or four days, or even sooner. It won’t be a normal vaccine trial that needs to go into thousands of thousands of patients to prove its safety and efficacy. Approvals to launch new drugs generally take about three to four years in India,” said Adar Poonawalla, Chief Ex-ecutive of Serum.

According to the World Health Organization (WHO), except for a dip in 2011, the number of den-gue cases in the country has been steadily rising since 2007. There is no dedicated treatment for the virus, and infected patients are generally asked to rest, drink flu-ids, and take paracetamol to bring down fever and reduce joint pains. There is no vaccine for dengue available in the market, but there are some undergoing clinical tri-als. Serum, the world’s fifth-largest vaccines maker by volume, will price its dengue treatment at be-tween 5,000 rupees ($75.85) and 10,000 rupees per injection.

Source: http://www.reuters.com

Virtual centre for bioenergyTo develop advanced technolo-gies in the area of bio-fuels, paving the way for a sustainable solution to the energy crisis, the Depart-ment of Biotechnology (DBT), under the Ministry of Science and

In the News

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6 VATIS UPDATE: Biotechnology n Oct-Dec 2015

Technology (MoST), government of India, has launched Pan-IIT Centre for Bioenergy, a virtual centre spread across five Indian Institutes of Technology – Bom-bay, Kharagpur, Guwahati, Jodh-pur, and Roorkee. The first virtual centre for collaborative research, to be coordinated by IIT Bombay, will focus on the thematic areas of research in advance bio-fuel technologies.

The collaboration, initiated in Jan-uary 2015 and engaged a research team from the five participating institutes, consisting of 32 inves-tigators who have been working on bioenergy, will jointly undertake research activities in cyanobacte-rial bio-fuels, biofuels from micro-algae, ligno-cellulosic bio-mass to biofuels and techno-economic and life cycle analysis. Though the first virtual centre, it is the fourth centre in bioenergy research set up by DBT in addition to the DBT-IOC Centre for Advanced Bioenergy Faridabad, DBT-ICT Centre for Energy Biosciences, Mumbai and DBT-ICGEB Centre for Advanced Bioenergy, New Delhi. The centre also aims to develop a mutually beneficial relationship with the bio-energy industry in India.

Source: http://www.thehindu.com

China to mass produce Ebola vaccineTianjin CanSino Biotechnology Inc., China, a private biotechnol-ogy company, plans to mass pro-duce a vaccine against the Ebola virus developed by Chinese mili-tary scientists. Tianjin has started construction of an industry base to produce the vaccine in the Tian-jin Economic and Technological Development Area (TEDA). In-vestment into the base totals 2

billion yuan (about $317 million) and construction will complete in September 2018.

The base also produces other vac-cines against pneumonia, men-ingitis and tuberculosis. Annual production is around 200 million vaccines. Developed by a team of biotech experts with the Chinese Academy of Military Medical Sci-ences, the Ebola vaccine is based on the 2014 mutant gene type and in the form of freeze-dried pow-der, which can remain stable for at least two weeks in temperatures of up to 37 degrees Celsius.

Experts say that it is suitable for the tropical climate in West Afri-can countries, where the deadly epidemic outbreak has killed more than 11,297 people since 2014. According to the ministry of health of Sierra Leone, one of the three most affected countries along with Liberia and Guinea, the vaccine has proven “clinically safe”. Since the outbreak, China has offered 120 million US dollars of aid and 500 medical staff and experts to affected countries.

Source: http://www.ndtv.com

India receives proposal for GM mustard plantationSince the United Progressive Al-liance (UPA) government in India put a moratorium on commercial cropping of Monsanto’s Bt Brinjal in 2010, the Centre has received the first ever proposal for clear-ance in 5 years to let farmers grow a transgenic food crop, a geneti-cally modified (GM) hybrid variety of the mustard plant. The decision on the proposal would have to be taken by the environment minis-try on behalf of the Union gov-ernment. This would not be the first time that a proposal for com-

mercial cultivation of GM Mustard comes up before the government.

Dr. Deepak Pental, developer of the GM mustard seed at Delhi University, said that he had sent the proposal to the Genetic En-gineering Appraisal Committee (GEAC) in mid-September. The GEAC is the statutory authority that appraises proposals for field trials and commercial release of GM crops, but its views are not binding on the government. The final call on such clearances lies with the Union environment, for-ests and climate change minister.

The planting season for mustard ends in the third week of Novem-ber. Rajasthan, Madhya Pradesh and Haryana account for nearly 70 per cent of India’s production of the crop. The National Democratic Alliance (NDA) has permitted field trials of GM crops in the past, de-spite opposition from Swadeshi Jagran Manch, an RSS-affiliate. Though decision-making on the issue has been put behind a veil of opaqueness. The GEAC took a decision last year to not disclose the agenda of its meetings or other information on the proposals it re-views pro-actively and provide it only in response to specific que-ries under the RTI Act.

Source: http://www.business-stand-ard.com

Global endoscopy market value to rise by $9.7 bnAccording to research and con-sulting firm GlobalData, the United Kingdom, the global endoscopy market will rise in value from $5.7 billion in 2014 to just under $9.7 billion by 2021, representing a Compound Annual Growth Rate (CAGR) of 6.9%. The company’s latest report stated that this

In the News

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VATIS UPDATE: Biotechnology n Oct-Dec 2015 7

growth, which will occur across the 10 major markets of the US, France, Germany, Italy, Spain, UK, Japan, Brazil, China and India, will be driven primarily by increasing adoption of endoscopic surgeries and screening programs, as well as a rising patient population.

Wenlu Hu, GlobalData’s analyst covering medical devices, said that the use of minimally invasive endoscopy techniques for both di-agnostic and therapeutic purposes will increase in proportion with the rising prevalence of diseases worldwide. “Endoscopy offers the possibility of accurate visualization of the current state of patients with a variety of diseases, which con-sequently improves the treatment process. Early disease diagnosis is the key to reducing healthcare expenses, meaning endoscopy techniques play a vital role in treating patients in the most cost-effective manner,” explained Hu.

The most promising areas of growth are colonoscopy, gastros-copy, cystoscopy, bronchoscopy, laryngoscopy, and endoscopy visualization systems, where there has been significant focus in terms of pipeline development. GlobalData’s report also stated that the endoscopy market is high-ly fragmented and experiences fierce pricing competition, mean-ing companies require shrewd corporate strategies in order to increase their market shares.

Source: http://www.biospectrumasia.com

Sinovac to supply flu vaccine in ChinaChinese government has recently announced Sinovac Biotech, China, as the supplier of the seasonal influenza vaccine for its 2015 vaccination campaign in Beijing. The Chinese govern-

ment said that it planned to order a minimum of 1.2 million doses of the seasonal flu vaccine from four manufacturers for its 2015 campaign. “We are pleased to be selected by the Chinese govern-ment to supply seasonal flu vac-cines for Beijing citizens. This vaccination campaign is an im-portant step in protecting geriatric and school-age populations from influenza,” said Mr. Weidong Yin, of Sinovac.

Every year, the Beijing evalu-ates potential suppliers on prod-uct quality, service and price, among other factors. Sinovac Biotech is a biopharmaceutical company that focuses on the research, development, manu-facturing, and commercialization of vaccines that protect against human infectious diseases. Sino-vac’s product portfolio includes vaccines against hepatitis A and B, seasonal influenza, H5N1 pan-demic influenza (avian flu), H1N1 influenza (swine flu), mumps and canine rabies.

Source: http://www.biospectrumasia.com

Researchers set to exploit supercomputer in JapanSGI Japan Ltd., a part of Silicon Graphics International Corp. (SGI), the United States, that deals with high-performance solutions for computer, data analytics and data management, has accepted an or-der from the Institute for Chemical Research (ICR) at Kyoto Univer-sity, Japan, for its next supercom-puter system, a SGI UV 2000. The new system will be used for Kyoto ICR’s advanced and interdiscipli-nary research in chemistry and biology. It will also be used by re-searchers throughout Japan as a shared computational platform for

national universities and research centers.

In addition, this system will be used as the platform for Genom-eNet, one of the world’s largest biological information services developed by ICR’s Bioinformatics Center and used by about 30,000 researchers per day from Japan and other countries. The super-computer will promote new life sci-ences research based on genome information and its application to drug discovery, medical care and environment conservation. SGI Japan will install the products, build the system, and perform operations and maintenance. The system will start operation in Janu-ary 2016.

The new system will enable the comprehensive analysis of many parameter spaces and larger and more reliable simulations for fields requiring high computation capa-bilities, like chemical calculation, including quantum chemical cal-culation and biomacromolecular modeling. This system will consist of five server groups: GenomeNet calculation servers, chemical cal-culation servers, GenomeNet servers, chemistry database serv-ers and file servers. These server groups will be combined with a fast Lustre file system and a large-ca-pacity NFS. The center of the sys-tem will contain the GenomeNet servers and chemical calculation servers.

Source: http://www.biospectrumasia.com

In the News

Program for Biosafety Systems

The Program supports partner countries in Africa and Asia in the responsible de-velopment and use of biotechnology to enhance agricultural innovation.

For more information, access:

http://pbs.ifpri.info

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8 VATIS UPDATE: Biotechnology n Oct-Dec 2015

Novartis launches first U.S. biosimilar drugNovartis, Switzerland, kicked off a new era in U.S. medicine with the launch of the first “biosimilar” copy of a biotechnology drug ap-proved in the United States, at a discount of 15 percent to the origi-nal. Novartis’ generics unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen, would increase access to an important treatment by of-fering a “high-quality, more afford-able version”. Amgen, the United States, had tried to stop the sale of Zarxio, also known as filgrastim-sndz, but the Washington-based appeals court rejected its attempt to block the launch. The potential for copycats to take business from original biotech drug brands is in-creasingly grabbing investors’ at-tention; although uncertainties re-main as to how quickly so-called biosimilars will win business.

Biosimilars have been on the mar-ket in Europe since 2006. How-ever, the U.S. regulatory pathway for biosimilars, which are made in living cells and can never be ex-act replicas of originals, was only established by a healthcare reform in 2010. Amgen said it intended to compete effectively with the new product and would base promotion on its 24 years of clinical experi-ence with Neupogen. According to Amgen, all biologics, including biosimilars, are highly complex molecules and each manufac-turer’s product will be distinct. The arrival of biosimilars threat-ens companies heavily reliant on biotech drugs, such as Amgen, AbbVie and Roche, and Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade.

Source: http://www.reuters.com

IAVI, CureVac partner to develop AIDS vaccineThe non-profit International AIDS Vaccine Initiative (IAVI) and bi-opharmaceutical company Cure-Vac, Germany, have partnered to accelerate the development of AIDS vaccines, utilizing novel im-munogens developed by IAVI and partners, delivered via CureVac’s novel messenger. HIV’s envelope protein or “trimer” is the primary target for antibodies that can neu-tralize a wide range of the virus’ strains, and which hold enormous promise in the quest for efficacious and broadly applicable AIDS vac-cines. In a major breakthrough, re-searchers have recently designed immunogens that successfully mimic this trimer.

In this collaboration, IAVI has se-lected one of its leading HIV trimer constructs to launch the mRNA evaluation in small-scale clinical trials: mRNA that encodes for the chosen trimer mimic will be con-structed using CureVac’s RNAc-tive® technology and injected with the aim of stimulating the body to produce HIV trimer proteins and then related neutralizing antibod-ies. “To date, most AIDS vaccine candidates have been based on DNA, viral vectors or protein. Us-ing mRNA could accelerate the development and testing of AIDS vaccine candidates. This col-laboration could be a real game-changer,” said Wayne Koff, at IAVI.

The development of vaccines that can generate neutralizing antibod-ies against HIV is a top priority for IAVI and many other researchers. Researchers at IAVI’s Neutralizing Antibody Center at The Scripps Research Institute, the United States, and elsewhere have de-signed several novel immunogens

that have the potential to elicit such antibodies. “We are excited to benefit from IAVI’s expertise in AIDS vaccine development, and its network and experience across the United States, Europe, Africa and India and to accelerate such development on the basis of our RNActive® technology,” said Ing-mar Hoerr, at CureVac.

Source: http://www.biospectrumin-dia.com

GSK may get EU nod for new biotech asthma drugGlaxoSmithKline, the United King-dom, may get a green light from European regulators for a new biotech medicine to treat severe asthma, boosting prospects for its struggling respiratory business. A recommendation from the Euro-pean Medicines Agency (EMA) would confirm the British drug-maker’s lead in a race to develop an injectable drug for patients with severe asthma who don’t respond well to traditional inhalers. GSK’s Nucala, or mepolizumab, is being assessed by experts according to an EMA agenda. Despite treat-ment advances in recent decades, asthma is still not well controlled in a significant minority of patients, creating what analysts believe is a multibillion-dollar opportunity for the new injections.

Rivals in the field include AstraZen-eca, the United Kingdom, Roche, Switzerland, Teva, Israel, and Sa-nofi, France, but Eric Dube, head of GSK’s respiratory business, believes his company is around one year ahead of rivals. “Clearly there is a first-mover advantage here. However, we don’t have that much time to establish Nucala as the leader in severe asthma,” said Dube. Significantly, the new drugs offer a more personalized approach

MARKET NEWS

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VATIS UPDATE: Biotechnology n Oct-Dec 2015 9

to asthma care, with patients un-dergoing so-called “biomarker” blood tests to check if they are likely to respond. This targeted approach is gaining traction in many medi-cal fields, most notably cancer, and drugmakers hope it will be attrac-tive to governments and insurers, since it means the drugs will only go to patients who are likely to benefit.

Biotech medicines like Nucala will not be cheap, since they are made from complex antibodies, though GSK is not giving any indication on cost before launch. GSK has been the leader in asthma since launch-ing its Ventolin inhaler in 1969 but its core respiratory business is cur-rently suffering, due to declining sales of top-seller Advair, while a successor inhaler, Breo, also had a recent setback. Nonetheless, Dube believes GSK will maintain its market-leading position in a global respiratory market that is growing by a modest 2 percent a year, although the shape of the business will be different in future.

Source: http://www.news.yahoo.com

Sanofi to launch new drugs in IndiaSanofi, France, has planned to bring to India a raft of innovative products, including a preventive dengue vaccine and an injectable medicine to cut cholesterol, to bol-ster its prospects in the market. The $36-billion (about Rs 2,35,000 crore) firm is looking to build up on an armoury of six innovative drug introductions, a clear upswing from the ‘pipeline drought’ compounded by a ‘patent cliff ‘ that hit most Big Pharma revenues in the last few years. “The prevalence rate of den-gue in India is a “classic example” of how the problem is under detect-ed and poorly understood. By the end of 2015, we will have submitted the regulatory file for approval in 20

countries. In case India has an ur-gent need to arrest the problem, we will do everything we can to try and make the product available here,” said Suresh Kumar, at Sanofi.

Sanofi’s two-decade-long chase for a dengue vaccine involved investments of 1.5 billion (about Rs 10,700 crore) and clinical tri-als on more than 40,000 people. The other ace innovations Sanofi is expected to take up for registration include high-end biologics such as the recently approved Praluent that significantly cuts cholesterol; Tou-jeo, a long-acting insulin for diabe-tes; dupilumab for atopic dermati-tis, which is in advanced stages of clinical trials; and sarilumab that is tested widely for treating rheu-matoid arthritis. Sanofi hopes the new drugs, once commercially available, will bolster the compa-ny’s prospects over its rivals while providing new and more effective treatment options for patients.

Source: http://www.economictimes.indiatimes.com

ICAR signs a strategic tie up with SABCThe Indian Council of Agricul-tural Research (ICAR) signed a memorandum of understanding (MOU) with the South Asia Bio-technology Centre (SABC) to ac-celerate the deployment of pub-lic bred genetically engineered crops in India. The MOU was signed by Dr. S. Ayyappan, DG ICAR & Secretary DARE and Dr. C.D. Mayee, founder director of SABC, coinciding the executive council meeting of the National Academy of Agricultural Scienc-es (NAAS). The ICAR and SABC will work jointly to create an inde-pendent platform to support tech-nology assessment and deploy-ment, biosafety and regulatory approval and outreach activities

of biotech products developed through national agricultural re-search system.

Dr. S. Ayyappan lauded the ef-forts and expressed hopes that the collaboration would improve understanding of the regulatory science protocols and guidelines of biotech products which is cru-cial for taking biotechnology from lab to land through a multi-layer regulatory system involving differ-ent ministries in India. He further emphasized that “Translating bio-tech research by ICAR into ulti-mate products is a key challenge for our scientific community. Regu-latory science and biosafety as-sessment studies assume a great significance to navigate through the regulatory system”. Dr. Mayee termed the MOU as a historic mile-stone in taking biotech products to farming community.

Source: http://www.icar.org.in

Market News

Biosafety resource book

The biosafety resource book of the Food and Agriculture Organization (FAO) stems from the experience gained in biosafety capacity development pro-jects and is based on the materials developed by the lecturers who have taught in the training courses organized to date.

The box includes five books whose subjects are: Introduction to molecular biology and genetic engineering, eco-logical aspects, risk analysis, test and post-release monitoring of genetically modified organisms (GMOs) and legal aspects. The resource book aims at providing biosafety regulators, policy makers and members of the national biosafety committees with reference materials that can be readily consulted beyond the training events, when the need arises.

For more information, contact:

Stylus Publishing, LLCPO Box 605, Herndon, VA 20172-0605Tel: (703) 661-1581 or (800) 232-0223

Fax: (703) 661-1501E-mail: StylusMail@PressWarehouse.

com

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10 VATIS UPDATE: Biotechnology n Oct-Dec 2015

Scientists create genetic design of inner ear cellUsing a sensitive new technol-ogy, scientists from US National Institute on Deafness and Other Communication Disorders (NID-CD), have created the first high-resolution gene expression map of the newborn mouse inner ear. The findings provide new insight into how hair cells and supporting cells in the inner ear develop and differ-entiate into specialized cells that serve critical functions for hearing and maintaining balance. Under-standing how these important cells form may provide a foundation for the potential development of cell-based therapies for treating hear-ing loss and balance disorders.

“Age-related hearing loss occurs gradually in most of us as we grow older. It is one of the most common conditions among older adults, af-fecting half of people over age 75,” said James F. Battey, at NIDCD. Hair cells and supporting cells can be damaged by medications, infec-tions or disease, injury and ageing, leading to hearing loss and balance problems. In humans, these cells cannot naturally repair themselves, so effective treatments are limited. To gain a better understanding of inner ear cell development, the team used single-cell RNA-seq – a new technology that can extract comprehensive gene activity data from just one cell.

The team analyzed 301 cells – some hair cells and some supporting cells – taken from the cochlea and utricle of newborn mice. By comparing the cells’ gene activity profiles, the re-searchers found unique patterns in hair cells and supporting cells. The data also allowed the scientists to identify distinct developmental pat-terns of gene activity. By analyz-ing the cells’ gene activity profiles,

the scientists were able to iden-tify genes that are active at each stage of development, bringing to light important clues about how the specialized hair cells are formed. Identifying the gene expression maps for the development of inner ear cells is essential to understand-ing how they form, and may help scientists create ways to regener-ate these cells.

Source: http://www.timesofindia.indiatimes.com

New technique to make dogs more strongerScientists from Guangzhou Insti-tutes of Biomedicine and Health (GIBH), China, have used a gene-editing technique to produce the world’s first genetically engineered pooches. Although these two en-deavors share scientific roots, with their production aimed at assisting medical research, unlike the teeny tiny pigs, the researchers behind this latest project are not intending to sell their customized animals as pets. So it probably won’t come as a surprise that the dogs weren’t engineered to be cuter, fluffier or more pocket-sized: they had their DNA tweaked to make them more muscly. The first of many potential edits the team would like to carry out, this was done with the forces in mind.

With greater muscle mass, the dogs “are expected to have a stronger running ability, which is good for hunting, police (military) applica-tions,” Liangxue Lai at GIBH. Later on down the line, the scientists would like to manipulate the dog genome in order to mimic human diseases, which could better our understanding and treatment of certain conditions. “Dogs exhibit close similarities to humans in terms of metabolic, physiological,

and anatomical characteristics,” the researchers wrote in the Jour-nal of Molecular Cell Biology, “and thus are ideal genetic and clinical models to study human diseases.”

The term “gene-editing” may ring alarm bells in many, but the tech-nique used – CRISPR-Cas9 – is remarkably precise, cheap and ef-ficient, and it’s already widely used in scientific research. While this work was done with a more noble cause in mind, aiding scientific research, the authors do wrote in the paper that the technique could also be used to create dogs with favorable traits for other purposes, although this doesn’t necessarily mean pets. The ethics of creating designer companion dogs could be argued, but it’s not really that different to what humans have been doing with the species for thousands of years anyway, al-beit this method significantly cuts corners.

Source: http://www.iflscience.com

Researchers uncover a novel linkAccording to a research done by University of Sussex, the United Kingdom, a small molecule in cells that was previously believed to have no impact on animal behav-iour could in fact be responsible for controlling precise movements. The team led by Dr. Claudio Alon-so, found that fruit flies had diffi-culty in righting themselves when placed upside down after changes were made to tiny pieces of their genetic material encoding microR-NAs (miRNAs). MiRNAs are mol-ecules encoded in the genome of all animals, including humans that regulate the activity of individual genes. MiRNAs have been shown to affect the formation of the nerv-ous system, but the Sussex-led re-search is the first to show that they

GENOMICS

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VATIS UPDATE: Biotechnology n Oct-Dec 2015 11

might also have very specific roles in controlling certain movements.

“We know very little about how simple movements are encoded in the genome. Yet, the survival of all animals including humans strongly depends on our ability to perform simple movements since the moment of birth, such as primi-tive reflexes essential for feeding. This knowledge might in the long-term contribute to the understand-ing of the underlying mechanisms of human disorders of the nervous system that lead to loss of move-ment coordination, such as Parkin-son’s disease,” said Dr. Alonso, at School of Life sciences, the United Kingdom.

The researchers had originally tried ‘switching off’ individual mi-croRNA molecules to investigate how this affected the formation of fruit flies’ nervous systems. When they found no apparent effects on the structure of the nervous system of fruit flies lacking the miRNA, they instead investigat-ed whether the nervous system ‘worked’ properly. This was when they discovered that fruit flies lack-ing a specific miRNA could not correct their position when placed upside down. Dr Alonso and his team are now turning their atten-tion to whether different miRNA molecules could be responsible for other movements both in the fruit fly and in other organisms.

Source: http://www.phys.org

Scientists predict the human genome using evolutionProfessor Sudhir Kumar and col-leagues from Temple University, the United States, have devel-oped a new approach to gain a clearer picture of health and dis-

ease, by providing an independent reference for all human variation by looking through the evolution-ary lens of our nearest relatives. “There are two ways to generate a map of the human genome vari-ation: one is to get genomes of all the humans and build a compila-tion as the 1,000 Genomes Project and others have undertaken. The alternative, which is the basis of our approach, is to compile all ge-nome data from other species and predict what the human sequence reference should be,” said Kumar.

By observing evolution’s “greatest hits” (and misses) and the history of the major themes and patterns of genome conservation (and di-vergence) across many species, Kumar’s approach predicts prob-able mutations that will be found among people and the fate of hu-man variation. His research team relied on an evolutionary tree that included 46 vertebrate species spanning over 500 million years of life on Earth to predict the evo-lutionary probability (EP) of each possibility at each position of our genome. They applied their new method on all protein-cod-ing genes in the human genome (more than 10 million positions).

Next, they produced a complete evolutionary catalog of all human protein variation, or evolutionary variome (eVar), that can be used to better understand human dis-eases and adaptations. And, it can be directly applied to the genomes of any other species. Lastly, they found a large number (36,691) of variations, that according to the EP data were evolutionarily improba-ble (EP less than 0.05), but were found 100 percent of the time in the 1,000 Genomes Project data, which could be strong candidates for adaptive evolution and what may make us uniquely human.

Source: http://www.eurekalert.org

New way to edit genesIn a study researchers from Wash-ington State University, the United States, have provided evidence that tapping into the cell’s homol-ogous recombination repair path-way is a much more efficient and precise way to go about it. “This new method is an improvement because it can be used not just to disrupt a gene, but also to in-sert new information into a specific site in the genome,” said Annalisa VanHook, web editor of Science Signaling, the United States.

Indeed, in addition to transfecting T cells with mRNA nucleases, the researchers also delivered a repair template that coded for gene they wanted to knock-in. “That gene is flanked by sequences that match the target gene. So we get seam-less integration of our gene,” ex-plained Guillermo Romano Ibarra of Seattle Children’s Research Institute, the United States.

The group demonstrated the suc-cess of their technique first using a reporter gene, and then with gene cassettes with therapeutic relevance, such as rewriting the CCR5 gene to encode a receptor that protects T cells from HIV in-fection. The study offers a new ap-proach to genetically engineering T cells to combat HIV and poten-tially other diseases like cancer.

Source: http://www.the-scientist.com

Genomics

UNIDO e-Biosafety Training Platform

The platform provides training to devel-oping country researchers, government and industry professionals involved in the assessment and management of risks related to biotechnology-derived products and services.

For more information, access:

http://binas.unido.org/moodle/

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12 VATIS UPDATE: Biotechnology n Oct-Dec 2015

Proteomics marks traction on a global scaleBiotech company Proteomics In-ternational Laboratories (PIQ), Australia, is pressing forward with multiple major upside opportunities as a key health test international-ises and an options issue unfolds. The company’s proteomics-based technology platform is developing next-generation diagnostic tests based on differences in the protein make-up of people with and without a particular disease. The method can be applied to allow for person-alised medicine treatments or to improve agricultural results. The Company is also rewarding share-holders with a ‘loyalty options’ issue this month, with the issue fully un-derwritten and raising A$126,450.

Other signs of traction have includ-ed the signing of a protein analys-ing contract in April with a $330 million Australian milk company and steady development of PIQ’s flagship product: a ground break-ing predictive test for the diagnosis of diabetic kidney disease (DKD). Marketability of PromarkerD is sup-ported by growing rates of DKD and the fact that there is currently no available test for predicting the on-set of the disease. “The current gold standard urine-based test for DKD is not robust, with results differing simply by taking a walk around the block before being tested,” said Dr Richard Lipscombe, at PIQ.

Critically, PromarkerD differs in that it also offers a prognostic (pre-dictive) test. PromarkerD’s capac-ity to generate cash via licensing fees, upfront payments and royal-ties is strengthened by a diversi-fied range of commercialisation options in various niche diagnos-tic test applications. Avenues for monetising the technology have been identified in a range of medi-

cal applications, including special-ist diagnostic tests run by clinical laboratories, clinical pathology tests produced by diagnostic com-panies and companion diagnostic tests used to monitor a patient’s response to drug therapy. PIQ is in a strong position regarding com-mercialising this intellectual prop-erty, with patents pending in major jurisdictions for PromarkerD.

Source: http://www.proactiveinves-tors.com.au

Scientists discover new RNA moleculesScientists from the German Can-cer Research Center (DKFZ) have discovered how RNA molecules regulate the structure of the nu-cleolus and drive the synthesis of the cellular machinery needed for protein production. When cells grow and divide rapidly, they need to run up the production of pro-teins. The cellular machinery for this task is synthesized and as-sembled in a special compartment of the cell nucleus called the nu-cleolus. The nucleolus constantly adapts its shape if the cell needs to produce more or less protein. Accordingly, fast dividing tumor cells often have bigger nucleoli.

Scientists found a novel mecha-nism that sheds light on how the nucleolus is able to change its structure as needed. Cells have to continually tune their metabolism in response to signals from their environment. To cope with this need, the nucleolus has a very dy-namic structure. It becomes bigger if cells’ metabolism is high, as it is the case for cancer cells that grow and spread very rapidly. On the other hand, structural aberrations and decreased activity of the nu-cleolus are found in starving cells or in association with heart disease and neurological disorders. Thus,

it reflects the cell’s condition and acts as a central hub for integrat-ing and responding to external and cellular signals. In extreme cases, stress stimuli applied to the nucle-olus can lead to cell death.

This characteristic is currently ex-ploited to develop therapeutic treat-ments, which target the nucleolus, to block highly proliferating cancer cells. The scientists observed that inhibiting the production of RNAs coding for proteins, the messen-ger RNAs, completely shattered the nucleolus into small pieces. By sequencing the RNA content of nu-cleoli, they identified parts of mes-senger RNAs that were needed for keeping the structure intact. This RNA type, called aluRNA, origi-nated from what was previously thought to be a useless by-product of messenger RNA synthesis. The aluRNA binds to certain proteins and, like a glue, keeps together the parts of the genome that associate within the nucleolus.

Source: http://www.research-in-germany.org

Researchers develop proteins tweaking techniqueResearchers from Ludwig-Maxi-milians-Universitaet (LMU), Ger-many, have developed a rapid and efficient technique for targeted chemoenzymatic functionalization of proteins. The new method has a wide range of potential therapeutic applications. Selective intermolec-ular recognition is at the heart of all biological processes. Thus pro-teins that bind specifically to com-plementary chemical structures are also indispensable for many biochemical and biotechnological applications. Targeted modifica-tion of such proteins therefore plays a significant role in medical diagnostics and therapies.

PROTEOMICS

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Led by Professor Heinrich Leon-hardt at LMU and Professor Chris-tian Hackenberger of the Leibniz In-stitute for Molecular Pharmacology (FMP), Germany, have developed a new strategy that permits specific chemical modification of virtually any protein more rapidly and more efficiently than was hitherto possi-ble. Many of the methods routinely used in the biosciences are based on the specific modification of pro-teins, in particular antibodies, to endow them with novel properties for specific purposes. For example, chemotherapeutic agents used in the treatment of cancer are often chemically linked to antibodies that recognize antigens found only on the surface of the target tumor.

In this way, the cytoxic drug can be delivered directly to the cells it is intended to eradicate. Ideally, the methods used to introduce such modifications should be as specific, efficient and versatile as possible. Unfortunately, the techniques cur-rently in use fulfill these criteria only in part. The new method is the first to make use of the enzyme tubulin-tyrosine ligase (TTL) and its target sequence. TTL binds to a short amino-acid sequence found in its natural target the cytoskeletal pro-tein tubulin and adds the amino-ac-id tyrosine to its C-terminal end. The researchers therefore refer to this guide sequence as ‘the Tub-tag’.

Source: http://www.eurekalert.org

SCIEX to develop new R&D centreSCIEX, the United States, a global leader in life science analytical tech-nologies, has announced that the University of Manchester, the United Kingdom, has invested in a large suite of high-end SCIEX mass spec-trometers for targeted and next-generation proteomics for its new Stoller Biomarker Discovery Centre.

With SCIEX’s SWATH® Acquisition technologies, the Centre will be one of the biggest clinical proteomics fa-cilities in the world. It will focus on industrializing proteomics research, and spearhead a series of biomark-er development projects and inter-national collaborations.

The new center, expected to open in mid-2016, will include SCIEX sci-entists working in partnership with University researchers to develop and trial new omics workflows in a real-world setting. Adverse drug re-actions (ADR) are estimated to be the fourth leading cause of death in the US – ahead of pulmonary dis-ease, diabetes, AIDS, pneumonia, accidents and automobile deaths.

University’s new research center will rely on SCIEX’s TripleTOF® 6600 Systems with SWATH Acqui-sition for highly reproducible and large-scale biomarker discovery and validation. The University of Manchester has also invested in a number of SCIEX QTRAP® 6500 Systems that will allow its research-ers to quickly convert the novel biomarker discoveries into routine MRM-based targeted proteomics assays, rather than spending many months generating antibody-based immunoassays. To support the in-dustrialization of proteomics, the University of Manchester is also investing in a number of liquid chro-matography and automated sample preparation components for the Stoller Biomarker Discovery Centre.

Source: http://www.businesswire.com

New protein manufacturing process unveiledResearchers from Northwestern University, the United States, and Yale University, the United States, have developed a user-friendly

technology to help scientists un-derstand how proteins work and fix them when they are broken. Such knowledge could pave the way for new drugs for a myriad of diseases, including cancer. The human body has a nifty way of turning its proteins on and off to alter their function and activity in cells: phosphorylation, the reversible attachment of phosphate groups to proteins. These “decora-tions” on proteins provide an enor-mous variety of function and are essential to all forms of life. Little is known, however, about how this dynamic process works in humans.

Using a special strain of E. coli bacteria, the researchers have built a cell-free protein synthe-sis platform technology that can manufacture large quantities of these human phosphoproteins for scientific study. This will enable scientists to learn more about the function and structure of phospho-proteins and identify which ones are involved in disease. “This in-novation will help advance the un-derstanding of human biochemis-try and physiology,” said Michael C. Jewett, at Northwestern. The study has been published in the journal Nature Communications.

Jewett and his colleagues com-bined state-of-the-art genome en-gineering tools and engineered bio-logical “parts” into a “plug-and-play” protein expression platform that is cell-free. Cell-free systems acti-vate complex biological systems without using living intact cells. Crude cell lysates, or extracts, are employed instead. Specifically, the researchers prepared cell lysates of genomically recoded bacteria that incorporate amino acids not found in nature. This allowed them to harness the cell’s engineered machinery and turn it into a factory, capable of on-demand bio manu-facturing new classes of proteins.

Source: http://www.nanowerk.com

Proteomics

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14 VATIS UPDATE: Biotechnology n Oct-Dec 2015

New discovery to develop antibioticsThe scientists at the Centre for Cellular and Molecular Biology (CCMB), India, have identified a potential area where new antibiot-ics can be developed. The identi-fication of “potential drug target” by CCMB scientist Manjula Reddy and her team assumes importance as the drug-resistance in bacteria is increasing worldwide and devel-opment of new antibiotics is de-clining over the years. “If we have to increase the size of a room, we have to break the walls and put new bricks. Likewise, bacteria are covered with a cell wall. The cell wall is made with something called peptidoglycan. If the cell has to increase in size, it has to break what is there earlier and put new pieces. If it cannot break, cell wall cannot grow,” said Ch Mohan Rao, at CCMB.

The study has been published in the journal Proceedings of the National Academy of Sciences. The CCMB scientists have also made a critical discovery in meio-sis, Rao said. Meiosis is a special form of cell division that splits ge-nome in two, so that chromosome number is maintained in the em-bryo after fertilisation. Errors in meiosis cause infertility and birth defects. They account for a ma-jority of congenital birth defects. In plants, meiosis can be by-passed to produce clonal seeds by apomixes (an asexual mode of seed formation), which would be of immense agricultural and eco-nomical importance if engineered in crops. Using the model plant Arabidopsis thaliana, the CCMB scientists identified a gene called DUET as the first known regula-tor of meiotic gene expression in plants.

Source: http://www.thehansindia.com

Hair stem cells to repair damaged nervesScientists from Newcastle Uni-versity, the United Kingdom, have successfully converted stem cells into large quantities of Schwann cells, which are a type of cell used in nerve repair. When pe-ripheral nerves – those outside the brain and spinal column – are damaged, they can be treated using grafts taken from nerves elsewhere in the body. “Many people sustain peripheral nerve injuries – in the arms, legs, and torso. If it is a small injury they can sew together two stumps of the nerve and it regenerates. If it is a large injury, the gap needs to be bridged,” said Professor Maya Sieber-Blum at Newcastle University.

That injures the donor nerve so you perpetuate the injury,” said Sieber-Blum. Along with her col-leagues, Sieber-Blum demonstrat-ed that the hair follicle can instead be a source of stem cells that can then be cultured in their millions and converted into a homogenous population of nerve repair cells. The next step will be to create a scaffolding on which these cells can then grow nerves – to bridge the gap between damaged parts – and see if the technique works in the body.

Source: http://www.business-stand-ard.com

New vaccine against chronic hepatitis BA new vaccine developed by re-searchers of the Center for Genet-ic Engineering and Biotechnology (CIGB), Cuba, called ‘HeberNas-vac’ for the treatment of chronic hepatitis B is currently undergo-ing clinical trials in Cuba and other

eight Asian countries, with the co-operation of Abivax, France. The new product that is administered nasally and subcutaneously, has proved to be more effective and safer than the rest of those exist-ing in the world today against the illness.

Studies of clinical evaluation have been approved by regulatory au-thorities in Australia, New Zealand, Republic of Korea, Singapore, Tai-wan, Hong Kong , the Philippines and Thailand. Also, the promising vaccine is supported by patents granted in the most demanding markets and has more than 20 scientific publications by Cuban experts with the cooperation of the Ehime University, Japan; the Society for the Study of the Liver, Bangladesh; the Pasteur Institute of France; and the University of Hanover, Germany.

It is expected to begin to be used in Cuba in 2016, after obtaining the approval of the sanitary reg-istration granted by the Center for State Control of Medica-ments, Equipment and Medical Devices (CECMED). According to the World Health Organiza-tion, chronic liver disease caused by the hepatitis B virus is one of the main causes of liver cancer, liver cirrhosis, and other com-plications such as esophageal varicose veins. Each year there are on the planet about one mil-lion deaths related to infection by this virus.

Source: http://www.cubanews.ain.cu

Researchers use DNA to engineer tiny human tissue A team led by the University of California San Francisco (UCSF), the United States, has developed a technique to build tiny models of

MEDICAL BIOTECH

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VATIS UPDATE: Biotechnology n Oct-Dec 2015 15

human tissues, called organoids, more precisely than ever before. These mini-tissues in a dish can be used to study how particular structural features of tissue af-fect normal growth or go awry in cancer. They could be used for therapeutic drug screening and to help teach researchers how to grow whole human organs. The new technique called DNA Pro-grammed Assembly of Cells) al-lows researchers to create arrays of thousands of custom-designed organoids, such as models of mammary glands containing sev-eral hundred cells each, which can be built within hours.

Studying how the cells of complex tissues like the mammary gland self-organise, make decisions as groups, and break down in disease has been a challenge to research-ers. The living organism is often too complex to identify the specific causes of a particular cellular be-havior. On the other hand, cells in a dish lack the critical element of realistic 3-D structure.

To specify the 3-D structure of their organoids, the researchers incubate cells with tiny snippets of single-stranded DNA engineered to slip into the cells’ outer mem-branes, covering each cell like the hairs on atennis ball. These DNA strands act both as a sort of molecular Velcro and as a bar code that specifies where each cell belongs within the organoid. When two cells incubated with complementary DNA strands come in contact, they stick fast. If the DNA sequences don’t match, the cells float on by. To turn these cellular LEGOs into arrays of or-ganoids, the team lays down the cells in layers, with multiple sets of cells designed to stick to particular partners.

Source: http://www.mumbaimirror.com

New therapeutic avenues for treating TBIn a new study, a group of scien-tists led by Prof. Amitabha Chatto-padhyay of Centre for Cellular and Molecular Biology (CCMB), India, have found that depletion of cho-lesterol content in host cell mem-brane results in significant reduc-tion in the entry of Mycobacterium smegmatis into the host cell. The most important and novel finding of the study was that infection was restored when cholesterol was put back to normal levels in the human cell membranes. During the study, which was carried out in collabo-ration with Dr. Tirumalai Raghu-nand’s group from the same insti-tute, scientists have used human host cells and injected laboratory strain of Mycobacterium into them.

They found that cholesterol was depleted when the cells were treated with methyl-beta cyclo-dextrin for about 30 minutes. The results were recently published in the journal Chemistry and Physics of Lipids. Interestingly, they found that infection was back when cho-lesterol was replenished to normal levels, indicating that the finding was specific to pathogenic Myco-bacterium.

In control experiments with non-pathogenic E. coli, the researchers found that its entry levels remained unaffected by depletion of choles-terol. Explaining the advantage of this approach for future therapeutic applications, Prof. Chattopadhyay said the focus would be on treating the host and not the parasite and this would naturally help in over-coming the problem of drug resist-ance. He said further studies would be carried out in animal models and eventually CCMB might look to collaborate with another institu-tion for conducting clinical studies.

Source: http://www.thehindu.com

First trial of umbilical cord stem cells to cure HIVThe world’s first clinical trial which aims to cure five HIV patients with-in three years using transplants of blood from umbilical cords has started at National Organisation of Transplants (ONT), Spain. The project seeks to be the world’s first clinical trial of its kind by recreating the success of Timothy Ray Brown – the only living person ever to be completely cured of HIV, known as “the Berlin patient”. ONT has selected 157 donors that have a genetic mutation which allows them to resist HIV. “The Berlin patient”, Brown, was an HIV-positive American living in Berlin in 2006 when he was diag-nosed with leukemia. He needed a transplant to treat the cancer, so his doctor decided to use a donor with a certain cellular mutation that is resistant to HIV. After Brown re-ceived two stem cell transplants from the donor’s bone marrow, his levels of HIV decreased dramati-cally. He is now cancer-free and only traces of the virus can found, but they cannot reproduce. Doctors last year said they suc-cessfully performed a similar pro-cedure on a man in Barcelona with lymphoma, but he died of the cancer not long after and they were unable to verify whether the disappearance of the virus was long-term. To see if Brown’s and the Barcelona patient’s cases can be replicated, the ONT project will look for HIV patients who also have leukemia, lymphoma, or simi-lar illnesses. The treatment will be more similar to that of the Barce-lona patient because doctors will transplant umbilical cord blood into the patients, rather than Brown’s stem cell transplant procedure.

Source: http://www.ndtv.com

Medical Biotech

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16 VATIS UPDATE: Biotechnology n Oct-Dec 2015

China to improve biotech approval processChina has agreed to improve an agricultural biotechnology ap-proval process that U.S. industry officials say has left a number of new products in limbo. U.S. indus-try officials are looking for China to accelerate final import approv-als for seven biotech traits and to speed up consideration of other genetically engineered crops in the pipeline. Officials from the Agriculture Department and the Chinese agriculture ministry dis-cussed the issue in a meeting called the ‘Strategic Agriculture Innovation Dialogue’. The White House fact sheet said the two countries “committed to further im-prove” the approval process. Both sides reaffirmed the importance of implementing timely, transparent, predictable, and science-based approval processes for products of agricultural biotechnology, which are based on international stand-ards.

Matt O’Mara, with the Biotechnol-ogy Industry Organization, praised the administration’s work in win-ning the commitment, which he called “an important first step.” He cautioned that streamlining China’s approval process is still likely to be “a long-term process.” However, USDA officials declined comment on the fact sheet. “I’ve expressed both publicly and pri-vately for the need for China to create a science-based, rules-based, consistent regulatory sys-tem that’s better coordinated and synchronized with our system and the system that is followed by other countries that are trading in and raising genetically modified crops,” said U.S. Agriculture Sec-retary Tom Vilsack.

Source: http://www.agri-pulse.com

First GMO corn crops in Viet NamAccording to a news report, genet-ically-modified (GM) corn varieties are likely to make a full scale in-vasion of the Vietnamese market soon as both farmers and traders are happy with high yields and potentially bigger profits. A rep-resentative of DeKalb, the United States, a company that sells GM seeds in Viet Nam, said his firm has started to sell seeds imported from South Africa to 800,000 corn farmers. DeKalb and Syngenta, Switzerland, will provide technical support for farmers planting GM seeds on 12-15 percent of their corn fields next year and aim to raise the rate to 50 percent in the next five years.

Farmers are assured that the ro-bust strains can save them VND2-3 million (US$90-134) in pesticide costs per hectare per year and their crops would sell for VND190,000 a kilogram, more than twice the cur-rent VND80,000. Farmers receiv-ing free seeds for trial cultivation have expressed confidence. Corn fields using Syngenta GM seeds in the northern province of Son La and the southern provinces of Ba Ria-Vung Tau and Dong Nai near Ho Chi Minh City have seen yields rise by 10-30 percent and profits by VND5-10 million per hectare.

Source: http://www.thanhniennews.com

GM plants could eliminate food poisoningA team of scientists from No-mad Bioscience, Germany, and Icon Genetics, Germany, have announced a new strategy for combating foodborne disease. Their method involves genetically engineering plants to produce

antimicrobial proteins, which can then be extracted and applied to contaminated meat and produce. In a study published in the Pro-ceedings of the National Acad-emy of Sciences, the scientists engineered tobacco, leafy beets, spinach, chicory and lettuce to produce proteins called colicins, which can kill deadly strains of E. coli. The team found that plants such as tobacco can yield high levels of active colicins. Further-more, they identified a mixture of two colicins that can efficiently kill all major disease-causing strains of E. coli.

“All of the food outbreaks that have been recorded in the last 15 years or so could have been controlled very well by a combination of just two colicins, applied at very low concentrations. Colicins are 50 times more active against bacteria than normal antibiotics,” said Yuri Gleba, at Nomad Bioscience. In the United States, nearly 300,000 E. coli infections occur each year, mainly through consumption of contaminated food. Most E. coli in food is found in contaminated beef and pork, but an increasing num-ber of E. coli infections have been linked to organic produce, which is typically treated with animal ma-nure in place of chemical fertiliz-ers. According to the World Health Organization (WHO), up to 10 per-cent of E. coli infections could lead to life-threatening disease.

Colicins are proteins naturally pro-duced by E. coli strains to kill or inhibit the growth of competing E. coli strains. The proteins are ex-tremely toxic – so toxic, in fact, that engineering microbes to produce colicins usually ends up killing the hosts. To circumvent that problem, the study’s authors decided to en-gineer plants, since colicins are not as toxic to plant cells. They were successful at getting various

AGRI BIOTECH

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VATIS UPDATE: Biotechnology n Oct-Dec 2015 17

plants to express large amounts of twelve different types of colicins – all of which were compositionally identical to colicins found natu-rally in E. coli. The team aims to get FDA approval of their process through a pathway called “gener-ally recognized as safe,” or GRAS.

Source: http://www.popsci.com

USAID grant to improve potato productionThe U.S. Agency for International Development has awarded Michi-gan State University (MSU), the United States, a $5.8 million co-operative agreement to improve potato production in Bangladesh and Indonesia. The grant supports USAID’s work under Feed the Fu-ture, the U.S. government’s global hunger and food security initiative. As part of this project, MSU will partner with the University of Min-nesota (U of M), the United States, and J.R. Simplot Comp., the Unit-ed States, along with in-country partners in both Bangladesh and Indonesia, to make improved po-tato varieties available to small-holder farmers. Such varieties can help protect against yield loss and improve livelihoods for those who depend on the crop to survive.

“Genetically engineered crops are among the technologies with po-tential to increase agricultural pro-ductivity, benefiting livelihoods of both small-scale and commercial farmers, while reducing inputs and environmental impacts,” said Dave Douches, at MSU. Late blight, the disease responsible for the historic Irish potato famine, is caused by a fungus-like pathogen and still has the potential to wreak havoc on today’s potato and tomato crops. To fight the disease, and subse-quently increase Bangladesh’s and Indonesia’s food security, the

researchers will work with in-coun-try partners to assess the validity of genetically engineered varie-ties, along with other approaches such as conventional fungicides, to develop the most-sustainable approach to maintain this impor-tant crop.

“This partnership combines MSU’s biotechnology pathology and po-tato breeding skills and the public sector regulatory skills from the U of M with the product development, commercialization and regulatory skills of J.R. Simplot Co. This, combined with the agricultural ex-pertise of the in-county partner in-stitutions, provides a public-private partnership that is aptly positioned to deliver a potato that’s resistant to late blight,” said Douches. Feed the Future is the U.S. government’s global hunger and food security ini-tiative. With a focus on smallholder farmers, particularly women, Feed the Future supports partner coun-tries in developing their agriculture sectors to spur economic growth and trade that increase incomes and reduce hunger, poverty and under nutrition.

Source: http://www.msutoday.msu.edu

Scientists discover new species of wild mushroomsScientists from the Botanical Sur-vey of India (BSI) have found these species from North Sikkim particu-larly in the subalpine region domi-nated by coniferous trees. Of these nine species, four belong to the genus Lactarius, whose character-istics are that they exude latex in large quantity and are commonly known as milk-caps. “These new species of fungi are mushrooms, seasonal in nature growing in dif-ferent times particularly during the rainy season. These species

were established after undertak-ing extensive and intensive field explorations followed by thorough micro-morphological studies and molecular systematics of the spe-cies,” said Kanad Das, at BSI.

Mr. Das, along with his team, has taken at least four survey tours to Sikkim to discover these species. Among the species discovered Canthrellus sikkimensis is edible. This species is tall and slim and interestingly is being consumed by locals. “What is unique about this species of Canthrellus is that they are more than double the size of other species of the genus reported from Indian subcontinent. While oth-er species of the genus is about 3-4 inches high this species is about six to seven inches high,” said Mr. Das.

“Fungi (including mushrooms) play a very important role in the growth and development of forests, as food, in industry and even in medi-cines like antibiotics. The discov-ery of new species can open new avenues for research and enhance availability of new food,” Paramjit Singh at BSI. So far about 2,000 species of mushrooms have been discovered from India. Across the world about 12,000 to 15000 spe-cies of mushrooms (small repre-sentative of Fungi) are found. It is believed that there are 5.1 million species of fungi are expected to be found in the world of which 1.03 lakh species are so far identified and reported from the world.

Source: http://www.thehindu.com

Agri Biotech

Biosafety database

The database is an open access search-able collection of scientific studies on biosafety and risk assessment in bio-technology.

For more information, contact:

E-mail: [email protected]://bibliosafety.icgeb.org

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18 VATIS UPDATE: Biotechnology n Oct-Dec 2015

Animal Biotechnology – Technologies, Markets and CompaniesThis report describes and evaluates animal bio-technology and its application in veterinary medi-cine and pharmaceuticals as well as improvement in food production. Knowledge of animal genetics is important in the application of biotechnology to man-age genetic disorders and improve animal breeding. Genomics, proteomics and bioinformatics are also being applied to animal biotechnology.

Microscopic Scale of Cancer Systems BiologyThis book introduces and explains various facets of the cancer systems biology in microscopic scale. This book is organized into three parts. After an introduction of cancer biology, the describe the mod-eling algorithms and their applicability limitations. At the end, the modeling of EGFR signaling in lung cancer is discussed as a case study and then two normal and cancerous EGFR signaling models are compared.

For the above two publications, contact: Springer (India) Private Ltd., 7th Floor, Vijaya Building, 17, Barakhamba Road, New Delhi 110001, India. Tel: +91-11-4575-5888; E-mail: [email protected]

3D Bioprinting and Nanotechnology in Tissue Engineering and Regenerative MedicineThis book provides an in depth introduction to these two technologies and their industrial applications. Stem cells in tissue regeneration are covered, along with nanobiomaterials. Commercialization, legal and regulatory considerations are also discussed in or-der to help you translate nanotechnology and 3D printing-based products to the marketplace and the clinic.

Contact: Elsevier Health, Reed Elsevier India Pvt. Ltd., 306, Centre Point, Andheri Kurla Road, J.B. Na-gar, Andheri (E), Mumbai (Maharashtra) – 400059, India. Tel: +91-22-66430975

20167-9 Jan India Medical Expo 2016 Bangalore, Contact: Mr. Rishi Dev Sharma India Sr. Assistant Director Tel: +91-11-2348-7493 Fax: +91-11-2332 0714 E-mail: [email protected] Web: http://www.indiamediexpo.in14-17 Jan 11th National Symposium on Bhubaneswar, ‘Innovations in Agriculture – Current India Status and Potentials under Changing Environment’ Contact: Dr. Roy Chowdhury Principal Scientist ICAR – IIWM, Chandrasekharpur Bhubaneswar – 751023 Odisha, India Tel: +91-674-2300-0010 E-mail: [email protected] Web: http://www.icar.org.in19-21 Jan Accelerating Biology 2016: Decoding Pune, India the Deluge Contact: Ms.Sayali Gongle Bioinformatics Group, Centre for Development of Advanced Computing (C-DAC), Pune University Campus, Ganesh Khind, Pune - 411 007, India Tel: +91-20-2569-4084 E-mail: [email protected] Website: http://www.cdac.in20-22 Jan Conference on Advances in Bioprocess Kolkata, India Engineering and Technology Contact: Dr. Pramita Sen Coordinator, ICABET 2016 Tel: +91-9831-088-581 E-mail: [email protected] Web: http://www.icabet.org22-23 Jan Seed Industry Program Bangalore, Contact: Sathguru Management Consultants India Plot 54, Sagar Society, Road No.2, Banjara Hills, Hyderabad-500034, India Tel: +91-40-3016-0333 E-mail: [email protected] Web: http://www.sathguru.com5-7 Feb 3rd International Conference on Pune, India Biotechnology and Bioinformatics (ICBB-2016) Contact: Dr. Sheo Mohan Singh Director International Center for Stem Cells, Cancer and Biotechnology (ICSCCB) Pune, India Web: http://www.icbb.in8-10 Feb BioAsia 2016 Hyderabad, Contact: BioAsia Secretariat India 301, Gayathri Nest Telecom Nagar, Gachibowli Hyderabad – 500032, Telangana Tel: +91-40-3000-4005 E-mail: [email protected] Web: http://www.2016.bioasia.in15-18 Feb 4th Biotechnology World Congress Dubai, UAE Contact: P.O. Box 121223 SAIF Zone Sharjah, U.A.E Tel: +971-6-5575783 E-mail: [email protected] Web: http://www.biotechworldcongress.com

TECH EVENTSRECENT PUBLICATIONS

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