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Category Archives: Biotechnology

EU sets out plan to simplify biotech regulation and speed up approvals – Science Business

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The European Commission is to look into how to speed up approvals for biotechnology, with a view to launching an EU Biotech Act in the next mandate, executive vice president Margrethe Vestager has announced.

Europe will not be attractive to businesses worldwide if permitting and other administrative procedures take much longer than in other parts of the world, she said, presenting the Commissions biotechnology and biomanufacturing initiative on 20 March.

In the meantime, it will establish an EU biotech hub by the end of this year, to enable biotech firms to better understand existing regulation, she said. The sector is already set to benefit from streamlined permitting procedures under the Net-Zero industry Act.

Applications of biotechnology and biomanufacturing range from replacing fossil fuels, to the discovery and development of new drugs for rare diseases, and bio-based alternatives to plastic and other materials. The EU funds research in the sector predominantly through the Circular Bio-based Europe Joint Undertaking (CBE JU), and more support is needed to help innovators scale up their technologies in Europe.

Regulatory complexity is one of three key obstacles to European competitiveness the new plan aims to address, alongside access to finance, and difficulties moving from research to the market.

The Commission is promising to review its Bioeconomy Strategy by the end of 2025, which could include a stronger industrial dimension.

To help companies scale up, the Commission will advocate for the inclusion of specific challenges on biotech and biomanufacturing in the European Innovation Council (EIC) accelerator work programme for 2025.

Europe cannot remain only a fantastic cradle of ideas for the rest of the world. What is born here should also have the opportunity to grow here, Vestager said.

To support the uptake of bio-manufactured products, the Commission will conduct an impact assessment for bio-based requirements in public procurement. It will further develop methodologies to ensure a fair comparison between fossil-based and bio-based products, as the latter are usually more expensive and their environmental benefits are not always apparent to consumers.

The EU is also betting on the potential of artificial intelligence to help companies scale up their operations. The 500 million GenAI4EU initiative aims to stimulate the uptake of generative AI in industries including biotech and biomanufacturing, and the Commission wants to give biotech firms access to EuroHPC supercomputers.

We want to make Europe a global biotech leader, said Vestager. With the potential to solve some of our most pressing problems, biotechnology also largely supports Europes economy, and it provides high-quality jobs.

Biotechnology can also pose a risk due to its dual-use potential, and the Commission is working with member states to assess the risk of technology leakage.

Biomanufacturing can be used to synthetically manufacture new molecules, said Vestager. These new molecules can have basic civilian uses, to produce sustainable pest repellents for instance. They can also be used in the military to produce new fuels for missiles.

Great first step

The biotech industry welcomed the announcements, which, coming so close to the European elections, mostly amount to identifying the major challenges and promising to address them at some point in the future.

To be competitive, the bio-based industries will require further action, including a sustainable supply of biomass and more stimulating measures for market uptake, such as bio-based content requirements under the new Ecodesign for Sustainable Products regulation, said Rob Beekers, chair of the Bio-based Industries Consortium, which represents the private sector in the CBE JU.

The new EU Parliament and EU Commission should make the bioeconomy and bio-based industries a political priority. Implementing the actions proposed in this communication would be a good start, he said.

Pauline Grimmer, policy manager at international nonprofit and think tank the Good Food Institute Europe, was also pleased to see the Commission recognise the measures that are needed.

While this is a great first step, for alternative protein startups to deliver on their potential to provide future-proof jobs and green growth, we now need to see this ambition translated into firm actions such as R&D funding, support to scale-up production and provide a clear and transparent regulatory framework, she said.

Claire Skentelbery, director general of industry association EuropaBio, said the initiative shows the Commission has listened to the industrys priorities. I think it's as promising as it can be for something that is a theoretical exercise. It shows intent to pick this up in the next Commission, she told Science|Business.

Clearer and faster regulatory pathways in the US are currently a major obstacle to European competitiveness. If you've got investors within the EU, they are going to push you to launch in the US first, Skentelbery said.

While a future EU Biotech Act is a positive long-term goal, theres a lot we can do in the short term thats going to be more beneficial, she added.

For example, the Commission and member states should work together on more standardised guidance for manufacturing using industrial biotechnology, while regulatory agencies are also in need of more resources to speed up approvals.

As the focus turns to implementation in the months and years ahead, EuropaBio wants to ensure any changes benefit startups and SMEs. Because its frontier technology, it really lies with the small innovators that spin out and start up companies around scientific advances, Skentelbery said.

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EU sets out plan to simplify biotech regulation and speed up approvals - Science Business

6 biotechnology universities in the UK leading the way for future talent – Labiotech.eu

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The U.K. has a selection of world-class universities offering biotechnology courses, whether students are looking for undergraduate or graduate programs. The country is also home to the golden triangle, encompassing the biotech hubs of Oxford, Cambridge, and London, all of which boast some of the worlds best universities for biotechnology.

In this article, we have listed six of the top biotechnology universities in the U.K.

Known for its academic excellence, the University of Cambridge has given rise to numerous famous science graduates, including Sir Isaac Newton, Charles Darwin, and Stephen Hawking.

The universitys Department of Chemical Engineering and Biotechnology offers an undergraduate course in Chemical Engineering and Biotechnology, which integrates the two topics together and teaches students the scientific principles that underpin them both, as well as how they can be applied to solve real-world problems.

Graduates of the course can expect to find careers such as: creating chemical and biological processes to transform molecules into valuable products; designing chemical and biological products for the benefit of society; using new technologies to facilitate the energy transition away from fossil fuels and to mitigate the effects of climate change; provision of improved healthcare and therapeutics; and using systems thinking to improve the sustainability of processes and products.

As well as the combined topic undergraduate course, the university also offers a Master of Philosophy (MPhil) specifically in Biotechnology. The program is designed to provide students with core and advanced knowledge skills, practical and research skills, and business skills in biotechnology.

To help matters further, the historic city of Cambridge itself happens to be a major biotech hub within the U.K. and is home to numerous startups and well-established companies, offering prospective graduates plenty of opportunities to get a job in the biotech industry once they leave university.

Just like the University of Cambridge, the University of Oxford is world-renowned for its academic prestige and is situated in another major biotech hub in the U.K., in the historic city of Oxford.

Even more impressive is the fact that the University of Oxford helped to develop one of the first COVID-19 vaccines with AstraZeneca, which just goes to show how much of a powerhouse it is in terms of scientific research.

This U.K. university offers two undergraduate courses related to biotechnology, which are Biomedical Sciences and Biochemistry. The Biomedical Sciences program focuses on how cells, organs, and systems function in the human body, while the Biochemistry program involves learning about the use of molecular methods to investigate, explain, and manipulate biological processes.

There are also a number of graduate programs to choose from at the University of Oxford, including a Doctor of Philosophy (PhD) in Biochemistry and a Master of Science (MSc) in Biochemistry, both of which aim to train students in cutting-edge laboratory research applying techniques in bionanotechnology, biophysics, computational biology, microscopy, molecular biology, structural biology, and systems biology to a broad range of fields including cell biology, chromosome biology, drug discovery, epigenetics, host-pathogen interactions, membrane proteins, ion channels and transporters, and RNA biology.

Additionally, a PhD course is available in Interdisciplinary Bioscience, which is a four-year course supported by the Biotechnology and Biological Sciences Research Council (BBSRC) that provides innovative training for graduates from a life science, physical science or computational and mathematical science background who wish to conduct leading-edge bioscience research.

Another one of the most prestigious universities in the U.K., based in the nations capital, Imperial College London (ICL) runs multiple undergraduate and graduate courses related to biotechnology, and is perhaps one of the most exciting universities in the U.K. to study biotech due to the array of options available.

The university has an undergraduate course in Biotechnology, which explores the vital links between biology and technology and teaches how bioprocesses can be applied to real-world situations. During the course, students will gain hands-on lab skills, while also learning about applications, industry, and entrepreneurship. There is even an optional year abroad or a year in industry/research. As well as simply studying biotechnology on its own, students can choose to take Biotechnology with Language for Science to advance language skills, or Biotechnology with Management to develop management potential.

Other undergraduate degrees offered at ICL that could offer you a career in biotechnology include Biomaterials and Tissue Engineering, Molecular Bioengineering, and Biochemistry.

ICLs graduate programs include three MSc courses. One is in Applied Biosciences and Biotechnology, which will provide students with an in-depth understanding of modern bioscience research and allow them to acquire the skills necessary to pursue a career in the field. Meanwhile, the second MSc course is Engineering for Biomedicine, in which students will learn how to tackle modern healthcare challenges with bioengineering technology, and the third course is Advanced Chemical Engineering with Biotechnology, which will provide students with a firm foundation in the science and engineering of biological processes.

And, for those more interested in active research, there are four Master of Research (MRes) programs available: Biological and Physical Chemistry, in which you can tackle the multidisciplinary problems that lie between life sciences and physical sciences; Cancer Technology, in which you can develop a unique understanding of cancer from a bioengineering perspective; Chemical Biology and Bio-Entrepreneurship, whereby you can learn the skills needed to address future scientific challenges in chemical biology; and Drug Discovery and Development, in which you can build your expertise in multidisciplinary drug discovery research and explore emerging technologies.

Another one of Londons prestigious universities is University College London (UCL). It is considered one of the top universities in the U.K. for courses that combine biotechnology skills with pharmaceutical management skills.

This is because it offers an MSc in Biotech and Pharmaceutical Management that focuses on the business and management of biotechnology and pharmaceutical ventures, as well as a Drug Discovery and Pharma Management MSc, which was introduced by UCL as a spin-off from the MSc Drug Discovery in response to the increasing opportunities which now exist for research scientists who can evaluate the business potential of their science as well as generate the science itself.

There are also undergraduate courses at UCL that students can take to help them launch a career in biotechnology. The UCL Department of Biochemical Engineering offers two main undergraduate programs. These are a Bachelor of Engineering (BEng) in Biochemical Engineering and a Bachelor of Science (BSc) in Bioprocessing of New Medicines (Business and Management). The BEng in Biochemical Engineering fully integrates engineering and biotechnology and is ideal for those who would like to explore careers in the biotechnology, pharmaceutical, or bioenergy sectors, while the BSc in Bioprocessing of New Medicines is designed to give students a firm grounding in both the science of bioprocessing and the management of new emerging technologies in healthcare.

Additionally, the university offers a Master of Engineering (MEng) in Biochemical Engineering, which is a four-year program that builds upon the BEng, enabling students to gain research skills. An MSc in Biochemical Engineering is also available to take, plus postgraduates can build on this even further, and have the opportunity to complete a PhD in Biochemical Engineering, too.

The University of Edinburgh is a top biotechnology university in the U.K. and is home to the Institute of Quantitive Biology, Biochemistry and Biotechnology, which brings together researchers from a range of backgrounds to tackle fundamental questions in biology and to develop biology-based solutions to real-world problems.

As well as offering a BSc in Biological Sciences, which gives a broad overview of the subject area, the university offers students the opportunity to specialize within Biological Sciences, including a BSc in Biological Sciences with a focus on biotechnology. In this program, students will explore areas including microbial biotechnology, genetic and cloning technologies, drug design, plant cell technology, synthetic biology, stem cells, and biological production methods.

There are also 12 other Biological Sciences degrees, with focus areas such as biochemistry, cell biology, genetics, and immunology.

The university also offers an MSc specifically in Biotechnology. Here, students will learn research and development skills to enable the creation of new products and services, investigate the economic basis for current biotechnology structures and areas of future demand, including the global pharmaceutical industry and carbon sequestration, learn how technology can be applied to solve pressing real-world biological problems, and gain the skills and expertise needed for future developments in biotechnology.

Furthermore, there is the option of an MSc in Synthetic Biology and Biotechnology, in which students will have the opportunity to develop the skills and knowledge necessary for developing innovative solutions and tackling the pressing global challenges we are facing, such as rapidly changing human demographics and resulting health pressures, growing demand for more and healthier food, resource shortages, and sustainable fuel transition and a cleaner environment.

The University of Manchester only offers a few biotechnology-related courses, but considering it is home to the Manchester Institute of Biotechnology, it is considered one of the best universities to study biotech in the U.K.

The institute was founded in 2006 to facilitate cross-disciplinary research to develop new biotechnologies that have applications in human health, the energy economy, food security, and the environment, and currently has more than 40 research groups that lead a portfolio of pioneering research projects that continue to advance our knowledge and uses of biotechnology.

The University of Manchester offers a 3-year BSc Biotechnology undergraduate program, in which students can develop a comprehensive understanding of science, technology and business management, and collaborate with entrepreneurs on a project to develop a business plan for real life sciences products. There is also the option to do a four-year BSc program in Biotechnology with Industrial/Professional Experience, in which students can spend the third year of their degree gaining valuable work experience to enhance their CV, with a choice of placements from placements all over the world.

In terms of graduate degrees, the university provides students with the opportunity to complete an MSc in Biotechnology and Enterprise. Here, students will learn how to turn scientific discoveries into inventions and commercial products and develop research skills in biotechnology and scientific knowledge applicable to a range of careers, including working as a consultant, in business development, as a research and development manager, patent engineer and technical specialist, or continuing research in a PhD program.

Over the years, there have been numerous biotech companies that have spun out of U.K. universities, which just goes to show the quality of research being conducted at the top universities in the country. In fact, the University of Oxford, the University of Cambridge, and ICL were all recently listed as the U.K.s most prolific universities when it comes to filing patent applications and producing startup spinouts with a focus on biotech, as well as artificial intelligence (AI) and greentech. Many of the top biotechnology universities in the U.K. also have partnerships with U.K.-based biotech companies. Perhaps one of the best examples of this is biotech company Apollo Therapeutics, which has core innovation sourcing and drug discovery collaborations with the University of Cambridge, UCL, ICL, and Kings College London, allowing it to translate some of the world-leading basic biomedical research conducted in the U.K. into innovative new therapies.

Partnering 2030: The Biotech Perspective 2023

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6 biotechnology universities in the UK leading the way for future talent - Labiotech.eu

Exploring Ag Biotech Careers with University of Connecticut 4-H – National Institute of Food and Agriculture

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USDAs National Institute of Food and Agriculture supports a variety of programs that prioritize educating the nations future professionals for these vital sectors of the economy. A University of Connecticut Extension program, supported by a program within NIFAs Agriculture and Food Research Initiative program, is opening doors for young people in the state to pursue those types of careers.

It is great to see 4-Hers learning about agricultural biotechnology, as well as future career opportunities in the field, said Dr. Manoharan Muthusamy, acting division director for NIFAs Division of Youth and 4-H. Efforts to provide real-world learning experiences and mentorship are essential to achieve our goal of building a highly skilled and diverse workforce in the food and agricultural sciences.

Read on to learn more about one participants journey.

The following was first published by the University of Connecticut and is reprinted with permission.

A decision to join an agriculture and biotechnology program offered by UConn 4-H became a catalyst for Zuzanna Rogowski, opening the door to new opportunities and potential careers. It all started when the Middletown High School junior learned about the 4-H program through her high schools agriscience program.

I was convinced that I wanted to go into biotech and medical school, Rogowski says. When I found out about the 4-H agricultural biotech program, I thought it was a good way to determine if it would be a good career for me.

Now, she says she feels she has more options and is also considering teaching the biotech class for a high school agriscience program. I didnt know that I could teach biotech in an agriscience program, the UConn 4-H biotechnology program opened up more careers and opportunities for me.

Advancing 4-H Youth Careers in Food and Agriculture via Biotechnology and STEM is a program that UConn Extension started offering in fall 2022. Jen Cushman, associate extension educator and state 4-H program leader, created the new initiative with team members from UConn and New Mexico State University.

The program helps youth build knowledge and career awareness as they learn about how biotechnology supports crops through climate resilience, CRISPR technology, and basic lab techniques, says Cushman. Youth members discuss and learn about the evolving field of agricultural biotechnology and what scientists worldwide are studying.

The program is built on the 4-H fundamentals of belonging, mastery, independenceand generosity.

Ive learned about the opportunities I have and what I can do in the future, Rogowski says. We spoke to UConn professors and met students. The connections the club has to the different workforce areas are my favorite part. The presentations from professionals showed how many options there are.

Rogowski completed CRISPR and gene mutation research, which aligned with her interest of bringing extinct animals back. She presented her ideas to the teams from New Mexico State University and UConn in March 2023 and continues her program involvement.

Opening Doors with 4-H

Amanda Thomson is a UConn 4-H volunteer in Middlesex County and an agriscience teacher at Middletown High School. She encouraged Rogowski to join the local 4-H club during her sophomore year in addition to the 4-H agriculture and biotechnology program.

The UConn 4-H program has provided many wonderful leadership and experiential learning opportunities for our members; it helps connect our members to real-world experiences, to one another, and to adult role models. Several of our members have discovered their career pathways by participating in the 4-H program, Thomson says.

Rogowski first joined the club and became the assistant coordinator for the Home Arts department at the Middlesex-New Haven 4-H Fair.

I was covering for someone at my first Fairboard meeting and didnt know what to do. Kate Yale, a UConn 4-H volunteer, told me it would all be fine, 4-H isnt a place that judges you, she made me really comfortable. 4-H is more fun than fear, I was scared to present the committee report at first, but quickly became comfortable doing it and the fear fell away and it became fun.

Rogowski also received a scholarship from the 4-H biotechnology and agriculture program to attend Ignite by 4-H, a national conference in Washington D.C. in March of 2023. Youth apply for the trip, are interviewed, and selections are made. The inclusive teen event offers workshops and programs, and gives youth the opportunity to learn, connect and share their ideas.

It was the opportunity of a lifetime and showed me that my career path is one I will enjoy, Rogowski reflects. It also showed me that no matter where you are from, a job isnt about money or credit, its about helping people in the future while helping myself. Ignite was cool because I met so many people and was introduced to perspectives other than my own. There were youth there from Alaska, Puerto Rico, and other places. It was a reality check that not everyone lives the way you do.

Last April, she attended UConn 4-H Citizenship Day at the Capitol in Hartford and experienced different government processes and met other 4-H youth from around the state. Two encouraged her to apply for the UConn 4-H Teen Council, and in November 2023, she began her service with the group.

Through 4-H I have seen Zuzanna grow as a leader and advocate. She has developed her knowledge of STEM-related activities and careers, demonstrated confidence as a public speaker, and discover how to work effectively as a team member, Thomson continues. Being selected as a state delegate to attend the Ignite conference in Washington, D.C. was a literal game changer; as its name implies, that experience truly lit a fire in Zuzanna that has spilled over to all other aspects of her life as a student, athlete, and leader. I am excited to see where 4-H leads her next.

Rogowski wants to become a state FFA officer, apply to UConn where she plants to major in agriscience education, and become a UConn 4-H mentor and volunteer in the future. She also has plans to volunteer internationally after completing her degree.

My best memory of 4-H is becoming part of the family and having people in 4-H around me, Rogowski concludes. Theres something for everyone in UConn 4-H and its warm and welcoming. We have mechanics, crafts, archery your project can be anything you choose it to be. 4-H has a place in your life no matter your age, ethnicity and what you like to do.

Advancing 4-H Youth Careers in Food and Agriculture via Biotechnology and STEM is supported by the Food and Agriculture Nonformal Education program, grant 2022-68018-36094 from the USDA National Institute of Food and Agriculture.

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Exploring Ag Biotech Careers with University of Connecticut 4-H - National Institute of Food and Agriculture

White House Unveils National Bioeconomy Board – Executive Gov

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The White House has launched the National Bioeconomy Board to work with public and private sectors to advance national security, competitiveness, economic productivity and sustainability through biotechnology and biomanufacturing.

The Office of Science and Technology Policy, the Department of Defense and the Department of Commerce co-chair the board, which includes representatives from nine additional federal agencies and departments, including the Department of Health and Human Services, NASA and the National Science Foundation, the White House said Friday.

The creation of the board is part of President Joe Bidens Investing in America agenda.

The boards efforts will complement the administrations implementation of the bioeconomy executive order signed in September 2022.

Some of the actions are the release of a lexicon by the National Institute of Standards and Technology to support risk assessments of the bioeconomy, the launch of an action plan to broaden biotechnology and biomanufacturing education and job training programs in the U.S. and the publication of a report on the establishment of a resilient biomass supply by the Department of Agriculture.

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White House Unveils National Bioeconomy Board - Executive Gov

Bioengineering to achieve carbon neutrality – EurekAlert

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It is difficult to go even one day without hearing terms that are intended to promote efforts to protect the global environment such as carbon neutrality, SDGs (Sustainable Development Goals), and ESG (Environmental, Social, and Governance) management. To achieve the Japanese and other state governments goal of balancing greenhouse gas (GHG) emissions by 2050, major technological breakthroughs are needed. Professor HASUNUMA Tomohisa (applied biochemistry, metabolic engineering), Director of the Engineering Biology Research Center, is a leading researcher in biotechnology. He uses genetically engineered smart cells of yeast,E. coli, and other bacteria to efficiently produce useful substitutes for petroleum and high valueadded functional materials. We interviewed Professor HASUNUMA, who is working to construct a next-generation, cross-disciplinary biorefinery that integrates biotechnology and digital technology, about his progress in his cutting-edge research.

Professor Hasunuma, you began as a researcher when you studied fermentation engineering at university. What was your motivation to major in fermentation engineering?

Hasunuma:I first became interested in biotechnology when my high school chemistry teacher stated that the age of biotechnology would come. Those words sparked my curiosity in biotechnology and I thought, I want to study living organisms at the molecular level based on chemistry, and then apply the research results to practical applications. I entered the Department of Biotechnology, Graduate School of Engineering, Osaka University, which was the center of fermentation science in Japan, and then continued to the doctoral course. The origin of microbial biotechnology is the study of brewing and fermentation of sake, miso, soy sauce, and other fermentable products.

As a student of Osaka University and a researcher of the Research Institute of Innovative Technology for the Earth (RITE), I studied plant biotechnology for carbon dioxide (CO2) reduction and worked on topics related to CO2reduction through vegetation expansion and material production. However, advances in research take a long time because higher plants have complex structures, which include roots, trunks, leaves, and other organs. Consistent with the change in RITEs research policy, I shifted my research focus to the cellular level with an emphasis on microorganisms, which are very simple.

Then you moved to Kobe University. Tell us more about that.

Hasunuma:When I started working at Kobe University in 2008, Professor FUKUDA Hideki, the former President of Kobe University and Professor KONDO Akihiko, the first Dean of the Graduate School of Science, Technology and Innovation, started an advanced fusion project called iBioK (Innovative BioProduction Kobe). With a grant of several billion yen over 11 years from the Japan Science and Technology Agency (JST), iBioK brought the best researchers in Japan to Kobe University to work on research and development of biorefinery. More than a dozen companies also participated. The project involved the construction of a value chain spanning the pretreatment of biomass, breeding of microorganisms, fermentation (material production), and separation and recovery of useful substances.

Will you please explain biorefinery?

Hasunuma:Biorefinery is an environmentally friendly technology that uses plants, which are sustainable resources, as raw materials to produce alternatives to fossil fuels and petrochemical products. The core of this technology is fermentation. Consequently, practical applications are difficult to achieve without improving the function of living organisms. In fact, in the 1990s, the realization of genome analysis technology to decipher entire genetic sequences of model organisms led to the so-called biotechnology boom. This boom attracted the attention of chemical and energy companies. Although bioproduction was attempted, this boom faded around 2000 because the organisms could not be controlled as expected and costs were high. Since then, advances in genome modification technology have made it possible to precisely control microorganisms. Additionally, the Paris Agreement signed in 2015 and the SDGs adopted by the United Nations have increased the global awareness of environmental issues. Under this context, expectations for the use of biotechnology in the bioeconomy and biomanufacturing have risen.

Can you tell us about the role of your research?

Hasunuma:Practical biorefineries will not be realized unless the production efficiency of useful substances by microorganisms is increased. Therefore, the Smart Cell Project, which aimed to develop microorganisms with a maximized substance production capacity, was implemented for 5 years starting in 2016. I participated as the R&D director. With funds totaling several billion yen from the New Energy and Industrial Technology Development Organization, a Japanese governmental R&D funding agency, the project united talented researchers across Japan, 16 universities, and 4 research institutes. Today, related research is ongoing and the technology is being developed.

Nowadays, it is not possible to survive the global R&D competition using only human power to manipulate, culture, and evaluate the production efficiency of genes of yeast,E. coli, etc. Advances in apparatuses that automate experiments have made it possible to develop smart cells more than ten times faster than manual work. At the end of 2021, we launched an autonomous experiment system called Autonomous Lab with Shimadzu Corporation. The Autonomous Lab integrates technologies and research results from different fields, including biotechnology, artificial intelligence (AI), and robotics. We call it biofoundry in an analogy to the foundries, which are semiconductor manufacturing plants. In Japan, Kobe University is the only university involved in such autonomous experimental efforts.

The biofoundry project has been selected for Kobe Universitys own Fostering Joint International Research.* You will be working on joint research with universities in the United States, Germany, France, the United Kingdom, China, Singapore, Taiwan, South Africa, and other countries. Can you tell us more about this project?

Hasunuma:The lab covers broad research themes as many things have yet to be understood. For example, how do smart cells grow and respond to environmental stresses? It is important to collaborate with researchers around the world to absorb missing knowledge and bolster our research. Due to the global presence of Kobe University, leading researchers from around the world are motivated to work with us. We will pursue research outcomes that cannot be achieved by Japanese researchers alone through international joint research.

You have founded a university-originating startup company with the aim of practical applications of research results, namely social implementation. Tell us more about this company.

Hasunuma:Yes, I am a technical advisor to Bacchus Bio Innovation, which I started with the encouragement of management experts at the Graduate School of Science, Technology and Innovation, Kobe University. Early-stage research is carried out at the university, but when the path to commercialization becomes clear, the research is handed over to Bacchus. For example, once highly efficient smart cells have been developed at the laboratory level, Bacchus will cultivate these smart cells in large quantities and deploy them in companies engaged in industrial production. We hope to achieve bio-first production, in which microorganisms are used to create not only petrochemical products such as fuels and plastics, but also cosmetics, supplements, and various other substances.

With the biofoundry in a full-scale operation, research is expected to accelerate. What are some of your mid- to long-term goals?

Hasunuma:As a researcher, I would like to clarify the reaction mechanisms occurring in living cells and to accurately understand metabolic mechanisms and other processes at the molecular level. As an engineer, I would like to develop technologies that can be linked to actual manufacturing and share the results of my research with the world.

Most importantly, we need to train more researchers in this field. There are not enough researchers who are familiar with both biotechnology and digital technology. In addition, there are not enough biotech researchers interested in robotics. Not only would I like to foster young researchers in these cross-disciplinary fields, but also like for them to gain international experience and expand their personal networks with overseas researchers. Executive Vice President KONDO guided me personally and cultivated my skills. Now, I have built a network of contacts with a variety of people, including those overseas. I believe that it is important to share such experiences with the next generation. Since it is crucial to integrate a wide range of research, I would like Kobe University to become an international center where talented individuals can gather to create a unique network of individuals whom we have fostered.

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Bioengineering to achieve carbon neutrality - EurekAlert

Where Does Vyne Therapeutics Inc (VYNE) Stock Fall in the Biotechnology Field After It Has Gained 35.71% This Week? – InvestorsObserver

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Where Does Vyne Therapeutics Inc (VYNE) Stock Fall in the Biotechnology Field After It Has Gained 35.71% This Week?  InvestorsObserver

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Where Does Vyne Therapeutics Inc (VYNE) Stock Fall in the Biotechnology Field After It Has Gained 35.71% This Week? - InvestorsObserver

What is Biotechnology? Master of Biotechnology

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The biotechnology revolution, fueled by the sequencing of the human genome, will affect every aspect of the way we live, from our environment, to what we eat, to how we diagnose and treat illness. Already, biotechnology has improved the quality of our lives. In the next decade, as the pace of advances in biotechnology accelerate, the scope and volume of biotechnologys effects will be even greater.

What is biotechnology? In its broadest definition, biotechnology is the use of advances in molecular biology for applications in human and animal health, agriculture, environment, and specialty biochemical manufacturing. In the next century, the major driving force for biotechnology will be the strategic use of genomic information. With the completion of the human genome project, the subsequent understanding of what these genes code for and how the products of these genes relate and interact, will completely transform the practice of medicine. It is now possible to translate discoveries in bacteria, yeast, or fruit flies into important therapeutic targets for drug discovery. DNA chip diagnostics, cell and gene therapy, and tissue engineering will emerge over the next ten years as important biotechnology products.

Biotechnology the interdisciplinary frontier between biology, engineering, medicine and plant science is also the scene of exciting scientific and technological developments in many areas of science. Important areas of development include:

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What is Biotechnology? Master of Biotechnology

Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis…

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Impacting more than 12 million people globally, HDV is the most aggressive form of viral hepatitis

Novel combination strategy designed toreduce HDV viremia and block viral entry

SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 SOLSTICE clinical trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus (HDV), which occurs as a simultaneous co-infection or super-infection alongside hepatitis B virus (HBV). HDV infection, the most aggressive form of viral hepatitis, increases the risk of poor outcomes, including liver cancer and death, compared with HBV alone.

VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) that diminishes the level of all HBV proteins in vitro, including hepatitis B surface antigen, a protein necessary to create infectious HDV virions. VIR-3434 is an investigational hepatitis B surface antigen targeting monoclonal antibody designed to remove both HBV and HDV virions from the blood and block the entry of these viruses into liver cells. VIR-2218 and VIR-3434 are currently being evaluated for the treatment of HBV in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial. Previously reported results from Part A of the MARCH trial demonstrated that the combination of VIR-3434 and VIR-2218 resulted in an approximate 3 log decline in hepatitis B surface antigen (HBsAg).

Globally, more than 12 million people are living with HDV, and with no approved therapies available in the United States, there is an urgent need for the development of novel treatment strategies that will improve outcomes for patients, said Carey Hwang, M.D., Ph.D., Virs senior vice president, clinical research, head of chronic infection. Recent research suggests that reducing HDV viremia, by preventing virion formation as well as facilitating virion removal, in conjunction with blocking HDV virion entry into liver cells could be effective in suppressing chronic HDV infection. The initiation of SOLSTICE, our first clinical trial in HDV, is an important milestone as we advance our broad therapeutic portfolio for viral hepatitis, which also includes the pursuit of a functional cure for chronic HBV infection.

Design of the Phase 2 SOLSTICE TrialThe multi-center, open-label Phase 2 SOLSTICE trial is designed to evaluate the safety, tolerability, and efficacy of VIR-2218 and VIR-3434 in adult patients (age 18 to 69) with chronic HDV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants will receive multiple doses of VIR-2218 and VIR-3434 as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a 2log10 decrease in HDV RNA compared to baseline, or HDV RNA less than the limit of quantification and normalization of alanine transaminase (ALT) at Week 24, as well as the proportion of participants with treatment-emergent adverse events and serious adverse events. Vir expects initial data from the SOLSTICE trial in 2023.

About Chronic Hepatitis DChronic hepatitis D virus (HDV) infection occurs as a simultaneous co-infection or super-infection with hepatitis B virus (HBV). An estimated 12 million patients globally are infected with HDV, representing approximately 5% of those infected with HBV. HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression toward hepatocellular carcinoma and liver-related death.

About Chronic Hepatitis BChronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with HBV and approximately 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy and poor tolerability. Vir is working to achieve a functional cure for the millions of people with HBV around the world through its broad and differentiated portfolio.

About VIR-2218VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the Companys collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434VIR-3434 is an investigational subcutaneously administered antibody designed to block entry of HBV and HDV viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencors Xtend and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV and HDV in infected patients, as well as to have an extended half-life.

About Vir BiotechnologyVir Biotechnologyis a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Vir routinely posts information that may be important to investors on its website.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, expect, anticipate, promising and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of VIR-2218 and VIR-3434 in combination to treat chronic HDV and HBV infection; the potential benefits of VIR-2218 and VIR-3434; Virs plans and expectations for its HDV and HBV portfolios; the initial results of the MARCH trial; the timing for and design of the Phase 2 SOLSTICE trial; the treatment of HDV and HBV; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including risks that Vir may not fully enroll the Phase 2 SOLSTICE trial or it will take longer than expected; unexpected safety or efficacy data or results observed during the Phase 2 SOLSTICE trial or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; challenges in accessing manufacturing capacity; successful development and/or commercialization of alternative product candidates by Virs competitors; changes in expected or existing competition; delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis...


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