Category Archives: Transhuman News

The NationalBioengineeredFood Disclosure Standard(NBFDS) which narrowlydefines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature kind of shot in the middle and missed every constituency,"observes Nate Ensrud, VP, US technical services, certification, and food safety solutionsatFoodChain ID, which helps firms to comply with the standard.

For some stakeholders in the natural foods industry, he says,it missed the mark,both in scope (the definition fails to capture thousands of products that have been produced with genetic engineering) and application (many objected to bioengineered vs GMO as the chosen terminology and the option to use digital disclosures on food labels).

For other stakeholders who believeslapping a blanket statement about bioengineering (which has thousands of different applications) on a jar of pasta sauce is about as useful as saying 'science was used to make this product," the NBFDS in its current form is just acostlybureaucratic headachewithout any obvious consumer benefit.

A major sticking point is the definitionof bioengineered, which excludes meat and dairy from animals fed GM feed, incidental additives, and highly refined oils and sweeteners made from GM crops such as soybean oil and high fructose corn syrup if they contain no detectable modified DNA.

Gene-edited foods, in turn, occupy something of a grey area. They may not contain detectable genetic material that has been modified through traditional rDNA techniques, but how easy is it for a third party to determine if gene-edited material meets the definition ofcannot be created through conventional breeding or found in nature?

Back in the day, says Ensrud, We were mostly talking about a series of crops that very obviously had genes inserted to express different traits.

"But since then, theres been a substantial proliferation of gene-edited products, products made using synthetic biology and so on, and while the [alternative meat, egg, and dairy]movement used to be pretty aligned, this is not the case anymore [as anyone following the social media debate about whether 'biotech' companies should be allowed to exhibit at Natural Products Expo West can see].

For example, under the NBFDS, firms deployingsynthetic biologyto re-tool the DNA of microbes to produce everything from flavors, sweeteners, and colors to animal-free collagen, egg, or dairy proteins are not required to label their ingredients as 'bioengineered' if there is no detectable level of the genetically modified host micro-organism in the final product.

This means that milk, ice cream, or cream cheese containing Perfect Days animal-free whey protein, which is expressed by a genetically engineered strain of fungi in a fermentation tank; or beverages containing Cargills EverSweet Reb M sweetener, made by GM bakers yeast, will not trigger a bioengineered label, if no GM material is detectable in the final ingredient.

However, burgers containing Motif FoodWorks 'meaty' animal-free heme protein myoglobin which is also made in a fermentation tank using a pichia pastoris yeast strain probably will trigger a bioengineered disclosure under the NBFDS, as trace amounts of the host microbe may be in the final product, says the company.

But even for exactly the same ingredient - myoglobin - no two companies producing this via fermentation are necessarily subject to the same labeling requirements when it comes to bioengineered food, saysBelgian startup Paleo, which has engineered a strain of pichia pastoristo express myoglobin in an extra-cellular fashion (it's secreted outside the cell).

This means its easier to separate myoglobin from the yeast cells during downstream processing and purification, such that Paleo'smyoglobin would not trigger bioengineered labeling in the US and would not be subject to EU GMO regulations, argues co-founder Hermes Sanctorum.

"Weve tested our heme proteins through PCR and there is no recombinant DNA whatsoever in our products.

The difficulty for companies trying to navigate this minefield is that the NBFDS doesn't really talk much about microbes"or much less explain how you label them with the exception of something like certain probiotics where genetically engineered bacteria might be the end product itself [rather than a production platform for something else], notes Ensrud.

To further complicate matters, he says:Then theres a really vague section of the of NBFDS that says if a company has actual knowledge its using something bioengineered, even if a food is not on the BE list, it is supposed to make a disclosure, which feels like a throwaway line, but how do you determine that?

He adds:We don't know a lot about how this will be enforced because the USDA has been clear that they're not going to be proactively enforcing this, but will be reliant on complaints. And so far, we havent seen very many well-structured complaints that can help us say, these are the areas that companies are going to challenge, and I don't know that it's going to be one of the first areas people think about because microbes are not included in the list of bioengineered foods.

USDA's Agricultural Marketing Service (AMS) has so farreceived just seven complaints alleging violations of the standard, said a spokesperson.

"If anyone suspects a violation may have occurred, they can file a written complaint with the AMS administrator by mail or on the AMS website. The administrator determines whether reasonable grounds exist for an investigation of the complaint, and if so, may request records from the entity responsible for disclosure. Based on those records, AMS will make its findings available to the regulated entity and provide them with an opportunity for a hearing. After the hearing, or if a hearing was not requested, once AMS has finalized its findings, AMS will make public a summary of the results of the investigation."

AMS does not have the authority to issue a recall or impose civil penalties for violations of the standard. However, states may adopt identical requirements and impose remedies for violations of their standards, explained the spokesperson. "USDA is not aware that any state has acted to impose such remedies."

The detectability factor makes practical sense, argue many stakeholders: if there's noGMOactually in the food, why should you have to label it?

But for organizations such as the Non-GMO Project that take issue withgenetic engineering in the food supply chain per se, whether there's actually any 'modified genetic material' left in soybean oil or a natural flavor is hardly the point, notes Ensrud.

Their goal is to establish a GMO-free supply chain, and so the gap between their definition of what should be labeled GMO and the NBFDS is an ocean wide.

Having said that, the Non-GMO Project has arguably gained traction as a result of all this confusion, given that foods without bioengineered labels are not necessarily Non-GMO given the narrow scope of the federal law, prompting shoppers that care about avoiding genetic engineering to seek outthe butterfly logo while shopping if they want to be sure.

So what about disclosure options, which like everything else in theNBFDS, have generated a lot of controversy? The standardpermits multiple options:

Aspects of the digital disclosure options have just been successfully challenged in a lawsuitbrought by the Center for Food Safety and others, with a court sending USDA back to the drawing board to make revisions consistent with Congressional requirements around consumer access.

So what does this mean for companies currently using the QR code or text message option? According to Ensrud, We did see some companies choose to use the QR code, but not a large majority by any means. The ones that were choosing QR codes told us they liked the flexibility, as perhaps they were still trying to remove some bioengineered foods from their supply chain and would move from having to disclose to not having to disclose, which would require a change in labels, which can be costly and laborious.

The opposite is also possible. If a company has to make an emergency shift from a non-GMO source to a GMO source for an ingredient [not that unusual given current supply chain volatility], it would likely change the labeling requirements. For companies that have less settled supply chains, this change in requirements could make things more difficult.

Sam Jockel, a senior associate at law firm Alston & Bird, noted that There is still an opportunity for either USDA or the plaintiffs in this case to appeal theruling, which I am watching for.

According to George Kimbrell, legal director at the Center for Food Safety, which filed the lawsuit challenging many aspects of the NBFDS, The Court did not set a deadline, but under law agencies cannot unduly delay such action and must complete it in a reasonable time.

Should the order ultimately stand, said Jockel,it appears that USDA would have discretion in terms of timing as the court did not set any deadlines for USDA to conduct its post-remand proceedings.

For those who think this means that the QR code will go away, added Jockel, The statute passed by Congress requires an electronic/digital link disclosure as one of the options along with the text and symbol, so the QR code option is not going away.

The Consumer Brands Association said it is still reviewing the court order, but added:"We plan to stay engaged during the forthcoming rulemaking and legal process, especially considering the potential impact on the companies using QR codes or texts. Consumer Brands will also continue supporting the valuable role digital disclosures play in boosting consumer transparency through programs like SmartLabel.

Jockel also noted that the scope of the products that require mandatory disclosure is actually subject to change.

Companies will want to watch for any updates to thelist of BE Foodsas AMS is required to review and consider updates on an annual basis. As the judges order put it in reference to the agencys regular updates to the List of BE Foods, AMS did not ignore the likelihood of progress. As evidence of that, the agency is currently proposing to expand the list to include insect-resistant sugarcane.

Greg Jaffe, biotechnology project director at the Center for Science in the Public Interest (CSPI), told us that an informal surveyconducted in his local Giant grocery store earlier in the year found that almost no companies use the symbol on the package with most seeming to opt for the bioengineered food or contains a bioengineered food ingredient option, although several brands had adopted QR codes.

My informal survey also found many foods disclose even though they probably only have highly refined ingredients, so companies are clearly erring on the side of giving more information to the consumer than might be required.

So has the law helped consumers make informed choices? Or are blanket references to bioengineered foods just wallpaper to busy shoppers?

I think that the law has provided consumers who want to know this information, more information than they would receive without the law, said Jaffe, who described it as a step in the right direction in terms of transparency, in part because companies were not providing this information voluntarily anywhere for the consumer who wanted it.

He added:I dont think many consumers look for this information or make purchasing choices based on it. With that said, for many consumers, knowing that there is transparency and information is available is important (i.e. knowing that information that some people might want is not hidden or inaccessible).

Asked about the growing number of ingredients produced by genetically engineered microbes, he said:Many ingredients made with engineered organisms also will not require disclosure, but I think it is important that those companies are transparent and provide information to consumers about the origin of the ingredients in their products, whether or not it has to be disclosed as bioengineered.

Being transparent with consumers will build trust, educate consumers about the use of biotechnology in foods, and allow for consumer choice.

Further reading:

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SPECIAL REPORT: Bioengineered food labeling: 'They kind of shot in the middle and missed every constituency' - FoodNavigator-USA.com

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About Fior Markets

Fior Markets is a futuristic market intelligence company, helping customers flourish their business strategies and make better decisions using actionable intelligence. With transparent information pool, we meet clients objectives, commitments on high standard and targeting possible prospects for SWOT analysis and market research reports. Fior Markets deploys a wide range of regional and global market intelligence research reports including industries like technology, pharmaceutical, consumer goods, food and beverages, chemicals, media, materials and many others.

Contact UsMark StoneHead of Business DevelopmentPhone: +1-201-465-4211Email: sales@fiormarkets.comWeb: http://www.fiormarkets.com

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Genome Editing Market 2022-2029 : Industry Projections Featured by Existing Research Methodologies and Assumptions 2029 The Colby Echo News - The...

Its a great honor for Creative Biolabs to participate and exhibit at the 13th Annual World Bispecific Summit and showcase the one-stop bispecific antibody solutions covering services and products involved in the whole pipeline of antibody discovery.

New York, USA September 28, 2022 The 13th World Bispecific Summit gathering of bi-, tri-, and multispecific drug discovery and development scientists, has come to an end. With years of devotion to the advancement of biotechnology, Creative Biolabs is highly honored to exhibit at this great event on September 20 and would like to take this opportunity to thank all of clients and partners for stopping by booth #2 this year, and to thank the host, Hanson Wade, as well as the presenters and participants for making this summit a success!

The on-site scientist team elaborately prepared gifts and brochures and hope that all the guests enjoyed their visits and came away with relevant solutions to their inquiries. At the exhibition, Creative Biolabs also presented one-stop bispecific antibody (BsAb) solutions covering the services involved in the whole pipeline of antibody discovery, including but not limited to:

BsAb design: target-based and MOA-based design

BsAb engineering: bispecific fusion, BsAb conjugates, bispecific IgG generation, etc.

BsAb purification: protein A/G/L chromatography, tag-based purification, etc.

BsAb analysis: biochemistry characterization, stability analysis, PK/PD analysis, etc.

BsAb manufacturing: genetic engineering, chemical conjugation, hybrid-hybridoma, etc.

The dedicated team is ready to go above and beyond to support clients projects with custom BsAb products, as well as a full list of recombinant antibody products and antibody engineering services.

We appreciate the critical role that academic and industrial scientists play in the path of improving human health as they diligently pursue further scientific innovation and discovery. We would love to participate in these events to meet and connect with more researchers, and we are also dedicated to promoting biotech research by providing trustworthy products, services, and innovative ideas. said a scientist from Creative Biolabs at the 13th World Bispecific Summit.

Explore innovative BsAb solutions and stay up-to-date on the upcoming events at https://www.creative-biolabs.com/bsab.

About Creative Biolabs

With more than a decade of exploration and expansion, Creative Biolabs has been dedicated to offering services on antibody discovery, engineering, production, and analysis. Especially, the bispecific antibody (BsAb) team has gathered a collective of experienced scientists committed to providing high-quality services to customers all over the world, covering BsAb design, purification, engineering, manufacturing, and BsAb analysis service. Besides, a variety of standard or customized BsAb products are also available for different research applications.

Media ContactCompany Name: Creative BiolabsContact Person: Candy SwiftEmail: Send EmailPhone: 1-631-830-6441Country: United StatesWebsite: https://www.creative-biolabs.com/bsab

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Creative Biolabs Unveils One-Stop BsAb Solutions at 13th Annual World Bispecific Summit - Digital Journal

ReportLinker

Protein therapeutic medicines are a class of pharmaceuticals used to treat a range of illnesses, including cancer, metabolic, hematological, immunological, hormonal, genetic, contagious diseases, and others.

New York, Sept. 28, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Protein Therapeutics Market Size, Share & Industry Trends Analysis Report By Product, By Application, By Regional Outlook and Forecast, 2022 2028" - https://www.reportlinker.com/p06322275/?utm_source=GNW These medications could greatly enhance human health. Protein distribution in appropriate amounts to the body to enable the precise functioning of various glands, as well as other organs in the body, is the basic concept behind protein therapy, which is conceptually related to gene therapy.

Genetically modified versions of naturally produced human proteins are called therapeutic proteins. They can be utilized to swap out proteins that are defective or lacking in a particular condition. They can also increase the supply of a helpful protein, which helps lessen the effects of chemotherapy or sickness. The proteins produced by genetic engineering can be made to closely match the natural proteins they are meant to replace, or they can be improved by the addition of sugars and other compounds that prolong the proteins activity.

A protein that is defective or lacking in a certain condition can be replaced with therapeutic proteins. They can also increase the bodys production of a helpful protein to lessen the effects of illness or chemotherapy. The proteins produced by genetic engineering may closely resemble the natural proteins they are intended to replace, or they may be improved.

Covid-19 Impact Analysis

The COVID-19 pandemic severely hampered the economy all over the world. A number of businesses were significantly demolished by the abrupt emergence of the pandemic. Moreover, several manufacturing and production facilities were closed owing to the outbreak due to the lockdown imposed by various governments within their countries. The protein therapeutics market was also disrupted in the initial period of the pandemic. Lockdown caused major delays within the development and delivery of crucial medical supplies. Attributed to this, the production of therapeutic protein was impeded.

Market Growth Factors

An increase in the cases of cancer across the world

One of the major factors that are driving the growth of the protein therapeutics market is the expansion in the prevalence of various types of cancer all over the world. Any disease that can affect any region of the body is referred to as cancer. Neoplasms and malignant tumors are other words that are used to denote this disease. One characteristic of cancer is the quick development of aberrant cells that expand outside of their normal borders, infiltrate other body components, and eventually move to other organs. This process is known as metastasis. The main reason why cancer patients die is because of widespread metastases within their bodies.

Rising focus of governments and regulatory bodies in accelerating the process of approval for this practice

A significant number of people in various developed, as well as developing nations who suffer from uncommon and complex diseases, depend on plasma-derived therapies every day as essential, life-saving medications. The need for these treatments, in particular immunoglobulins, has grown significantly and is still growing on a global scale. Plasma-derived therapies are treatments made from human plasma through a fractionation procedure in which the pertinent plasma proteins are isolated. The single largest component of human blood is called plasma, which is made up of proteins, salts, enzymes, and water. Primary and secondary immunodeficiencies, bleeding disorders, inhibitor deficiencies, and other rare diseases are all treated with plasma-derived medicines.

Market Restraining Factors

High manufacturing and administration cost

A major challenge in the growth of the protein therapeutics market is the high cost of protein therapies. Because of high product prices, some therapies that patients need for a speedy and complete recovery are no longer available. In several nations, prices are additionally governed by law. Through their authority over national healthcare organizations, which can cover a significant portion of the cost of distributing drugs to consumers, government bodies restrict costs.

Product Outlook

On the basis of Product, the Protein Therapeutics Market is segmented into Monoclonal Antibodies, Insulin, Fusion Protein, Erythropoietin, Interferon, Human Growth Hormone, and Follicle Stimulating Hormone. In 2021, the Insulin segment garnered a significant revenue share of the protein therapeutics market. The rise in the growth of the segment is majorly attributed to the increasing cases of diabetes all over the world. Insulin is a natural hormone, which is produced by the pancreas. The lack of production of this hormone is the factor that stimulates the diabetes level of the human body.

Application Outlook

By application, the Protein Therapeutics Market is segregated into Metabolic Disorders, Immunologic Disorders, Hematological Disorders, Cancer, Hormonal Disorders, Genetic Disorders, and Others. In 2021, the metabolic disorders segment procured the biggest revenue share of the protein therapeutics market. The rise in the growth of the segment is due to the exponential demand for high-quality medications and adaptable therapies for the treatment of diseases, particularly diabetes, which is anticipated to support the segments growth.

Regional Outlook

Region-wise, the Protein Therapeutics Market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. In 2021, North America held the largest revenue share of the protein therapeutics market. This is ascribed to an increase in the incidence of chronic diseases, the use of cutting-edge treatments, the presence of important players, and an increase in healthcare spending in the area. Moreover, North American countries are early adopters of several new technologies and approaches.

The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; Johnson & Johnson and Pfizer, Inc. are the forerunners in the Protein Therapeutics Market. Companies such as Merck & Co., Inc. Amgen, Inc., Eli Lilly and Company are some of the key innovators in Protein Therapeutics Market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Abbott Laboratories, Baxter International, Inc., Amgen, Inc., F. Hoffmann-La Roche Ltd., Eli Lilly and Company, Merck & Co., Inc., Johnson & Johnson (Janssen Global Services, LLC), Pfizer, Inc., Novo Nordisk A/S and Sanofi S.A.

Recent Strategies Deployed in Protein Therapeutics Market

Partnership, Collaboration and Agreements:

Aug-2022: Merck came into a collaboration with Orna Therapeutics, a biotechnology company. Following this collaboration, the companies would work on the discovery, development, and commercialization of multiple programs, encompassing therapeutics and vaccines in the sector of infectious disease and oncology.

Mar-2022: Novo Nordisk joined hands with Massachusetts Institutes of Technology and Brigham and Womens Hospital. Through this collaboration, the company aimed to leverage the distinct prospect to bring new transformational solutions to patients by utilizing its distinct capabilities.

Jan-2022: Amgen teamed up with Amgen Generate Biomedicines, a therapeutics company. Under this collaboration, the companies aimed to develop and manufacture protein therapeutics to address 5 clinical ailments.

Jan-2022: Merck teamed up with Absci, the drug, and target discovery company. Following this collaboration, Merck aimed to leverage Abscis platform to utilize its compelling opportunity intending to develop new biologic candidates as well as explore complex protein expression.

Aug-2021: Eli Lilly and Company joined hands with Lycia Therapeutics, a biotechnology company. Following this collaboration, the companies aimed to focus on the development, manufacturing, and marketing of new targeted therapeutics leveraging the proprietary lysosomal targeting chimera protein degradation technology of Lycia.

Sep-2020: Merck collaborated with Seattle Genetics, an American biotechnology company. With this collaboration, the companies aimed to further expand the oncology portfolio of Merck in order to enhance the lives of cancer patients.

Acquisition and Mergers:

Jun-2022: Pfizer took over ReViral, a privately held, clinical-stage biopharmaceutical company. Through this acquisition, the company aimed to integrate RSV investigational treatments of ReViral into its portfolio in order to acquire an offering of promising therapeutic candidates.

Nov-2021: Pfizer took over Trillium Therapeutics, a clinical-stage immuno-oncology company. This acquisition aimed to offer an impressive portfolio, including biologics, to Pfizer

Jul-2021: Amgen took over Teneobio, a clinical-stage biotechnology company. With this acquisition, the company aimed to leverage Teneobios antibody platform in order to complement its prevailing capabilities. Moreover, the company also aimed to gain a diverse range of building blocks that can be created into new multispecific therapeutics.

Jul-2021: Eli Lilly and Company completed its acquisition of Protomer, a pre-clinical stage biotechnology company. Under this acquisition, the company aimed to help Protomer in enhancing its diabetes range with its innovative technology.

Feb-2021: Merck took over VelosBio, a privately held clinical-stage biopharmaceutical company. Through this acquisition, the company aimed to boost its expanding oncology portfolio while also strengthening its long-term growth potential.

Aug-2020: Johnson & Johnson completed its acquisition of Momenta Pharmaceuticals, a biotechnology company. This acquisition aimed to strengthen Janssens position in the autoimmune diseases sector and offer a major catalyst for sustained growth of the company.

Approvals and Trials:

Sep-2020: Baxter International received the US FDA approval for its Clinimix and Clinimix E. The new formulations aimed to complement the offerings of medical formulations with their higher protein content.

Scope of the Study

Market Segments covered in the Report:

By Product

Monoclonal Antibodies

Human Growth Hormone

Fusion Protein

Insulin

Erythropoietin

Interferon

Follicle Stimulating Hormone

By Application

Metabolic Disorders

Immunologic Disorders

Hematological Disorders

Cancer

Hormonal Disorders

Genetic Disorders

Others

By Geography

North America

o US

o Canada

o Mexico

o Rest of North America

Europe

o Germany

o UK

o France

o Russia

o Spain

o Italy

o Rest of Europe

Asia Pacific

o China

o Japan

o India

o South Korea

o Singapore

o Malaysia

o Rest of Asia Pacific

LAMEA

o Brazil

o Argentina

o UAE

o Saudi Arabia

o South Africa

o Nigeria

o Rest of LAMEA

Companies Profiled

Abbott Laboratories

Baxter International, Inc.

Amgen, Inc.

F. Hoffmann-La Roche Ltd.

Eli Lilly And Company

Merck & Co., Inc.

Johnson & Johnson (Janssen Global Services, LLC)

Pfizer, Inc.

Novo Nordisk A/S

Sanofi S.A.

Unique Offerings

Original post:
The Global Protein Therapeutics Market size is expected to reach $490.2 billion by 2028, rising at a market growth of 6.9% CAGR during the forecast...

DUBLIN, Sept. 28, 2022 /PRNewswire/ --The "Synthetic Biology Market Size, Share, Trends, By Technology, By Tools, By Application, By End-use, and By Region Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

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According to a new report, the Synthetic Biology Market size was valued at USD 9.26 Billion in 2021 and is estimated to exceed USD 75.9 Billion in terms of revenue, at a CAGR of 26.3% through 2030. Synthetic biology is an emerging field of science that deals with the design and construction of artificial biological systems for various applications. The market for synthetic biology is expected to grow at a rapid pace owing to the increasing demand for synthetic genes, proteins, and other biomolecules in the pharmaceutical and biotechnology industries.

Products produced by synthetic biology are used in pharmaceutical and biotechnology research, as well as industrial applications. Increasing government funding for synthetic biology research and the ever-expanding application areas of synthetic biology are the major drivers of this market.

Synthetic biology has a potential in DNA sequencing, genetic engineering, and other biotechnology applications. It is anticipated that the demand for synthetic biology will rise in the pharmaceutical and biotech industries for the development of new therapeutic proteins and designer microbes.

Increased amount of study data generation with dipping prices of DNA sequencing, rise in government funding and initiatives, and need for efficient disease management are the prominent drivers of the synthetic biology market. In addition, new applications in healthcare and pharmaceutical industry is another significant factor that is anticipated to fuel the growth of this market during the forecast period.

Market Dynamics

Market Drivers

Rapid Technological Advancements in the Field of Synthetic Biology

Diverse Range of Synthetic Biology-Based Applications Leading to Widespread Adoption in the Biotechnology and Pharmaceutical Industries

Rising Investments Toward Research & Development (R&D) Activities for Synthetic Biology-Based Research

Story continues

Market Restraints

Potential Biosafety, Biosecurity, and Ethical Issues Related to the Unintended or Deliberate Misuse of Synthetic Biology Techniques

Stringent Government Regulations & Guidelines

Market Segmentation

Technology Outlook (Revenue, USD Billion; 2019-2030)

Tools Outlook (Revenue, USD Billion; 2019-2030)

Application Outlook (Revenue, USD Billion; 2019-2030)

Medical & Healthcare Application

Artificial Tissue & Tissue Regeneration

Environment & Agriculture

Bioprocess Industry

End-use Outlook (Revenue, USD Billion; 2019-2030)

Regional Outlook (Revenue, USD Billion; 2019-2030)

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Italy

Spain

Sweden

BENELUX

Rest of Europe

Asia-Pacific

China

India

Japan

South Korea

Rest of APAC

Latin America

Brazil

Rest of LATAM

Middle East & Africa

Saudi Arabia

UAE

South Africa

Israel

Rest of MEA

Key Topics Covered:

Chapter 1. Market Synopsis

Chapter 2. Executive Summary

Chapter 3. Indicative Metrics

Chapter 4. Synthetic Biology Market Segmentation & Impact Analysis

Chapter 5. Synthetic Biology Market By Technology Insights & Trends

Chapter 6. Synthetic Biology Market By Tools Insights & Trends

Chapter 7. Synthetic Biology Market By Application Insights & Trends

Chapter 8. Synthetic Biology Market By End-use Insights & Trends

Chapter 9. Synthetic Biology Market Regional Outlook

Chapter 10. Competitive Landscape

Chapter 11. Company Profiles

Companies Mentioned

Amyris Inc.

Ginkgo Bioworks

Codexis Inc.

Novozymes AG

Twist Biosciences

GenScrip Corporation.

Merck KGaD

Codex DNA Inc.

Eurofins Scientific Inc.

Amgen Inc.

For more information about this report visit https://www.researchandmarkets.com/r/vkyme3

Media Contact:

Research and MarketsLaura Wood, Senior Managerpress@researchandmarkets.com

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Global Synthetic Biology Market 2022: Diverse Range of Synthetic Biology-Based Applications Leading to Widespread Adoption - Yahoo Finance

Today, Unravel Biosciences and the Wyss Institute for Biologically Inspired Engineering at Harvard University announced that Unravel has licensed a drug discovery platform technology from Harvard and Tufts University. The company will use the technology, invented at the Wyss Institute, to decode and model complex diseases to accelerate the development of new and more effective therapies.

Harvards Office of Technology Development is providing an exclusive, worldwide license to Unravel for the diagnosis, treatment, and prevention of certain neurodevelopmental disorders using new and existing drugs developed with the platform.

The company is validating the technology by developing an effective therapy for Rett syndrome, a rare genetic disease that mostly affects girls and causes progressive loss of motor and language skills, seizures, and intellectual disabilities. By combining predictive algorithms, a high-throughput tadpole-based screening system, and an iterative discovery process, Unravel is taking a patient-centric approach to identify drugs that can restore health, first in Rett syndrome and later in other cognitive and behavioral disorders.

Unravels approach flips the traditional drug development process on its head. For the past 50 years, most pharmaceutical companies have started by identifying a molecular target of interest and then developed drugs to disrupt that target. But 90% of the drugs created via this process dont work in patients. In contrast, we start with an individual patient and ask, What is different about this patient thats causing this disease? We computationally predict which existing drugs could restore health in that patient, validate those drugs in our engineered animal models and focused clinical trials, and from there identify the underlying molecular targets that could be drugged to treat the disease across patient populations, said Richard Novak, Ph.D., a former Lead Staff Engineer at the Wyss Institute who is now CEO and co-founder of Unravel.

From DARPA project to Validation Project

The roots of the platform technology licensed by Unravel stretch back to 2015, when Novak and other members of the Wyss Institute led by Founding Director Don Ingber, M.D., Ph.D. started working on a DARPA-funded research project to identify drugs that could induce human tolerance to sepsis and other forms of infection. To figure out whether their candidate drugs might have any unexpected side effects on the brain, the team developed a cognitive assay and behavioral screening system using Xenopus laevis frog tadpoles in collaboration with Wyss Associate Faculty member Mike Levin, Ph.D.

Xenopus embryos are an amazingly tractable and powerful system for exploring the full stack of biology: from genes, to physiology, to anatomy, to behavior. The whole brain and nervous system forms in front of your eyes in a week! I was really excited about collaborating to use automated assays in this exquisite little animal to impact human medicine, said Levin, who is also the Vannevar Bush Chair of the Department of Biology and Director of the Allen Discovery Center at Tufts University.

The scientists quickly realized that their system, called CogniXense, could be used to evaluate the effects of a wide range of drugs on the cognitive and behavioral systems of a whole organism. This would allow them to identify drugs that can restore complex mental abilities that are often impaired in neurological diseases, a metric that is important to patients but difficult to measure in standard preclinical models.

A team was formed to develop CogniXense for that purpose. Shortly thereafter, the system highly impressed a visitor to the Wyss Institute, who had a daughter with a rare genetic disease that was classified as a form of Rett syndrome. This condition, which causes debilitating physical and mental problems in the ~10,000 patients who are born with it every year, has no cure or treatment.

Ingber suggested to Novak that CogniXense could be used to identify drugs to treat Rett syndrome, and the team got to work building a Xenopus model of the disease. In their first test, they found that their model replicated behavioral differences observed between healthy patients and those with Rett syndrome. They also identified several drugs that reversed the tadpoles symptoms. Based on this potential, the team was awarded Validation Project funding from the Wyss Institute in 2018 and 2019 to further de-risk and develop CogniXense into a high-throughput and automated drug discovery platform.

CogniXense consists of three main parts. The first is NeMoCAD, a computational algorithm that analyzes the transcriptome network features of existing drugs to predict which ones are most likely to reverse the features of a given disease. Second, Xenopus tadpoles are genetically modified using CRISPR to replicate the genetic signature of the disease and the resulting spectrum of behavioral and cognitive features in as little as three weeks. Finally, the modified tadpoles are placed into a screening instrument called the TadPool, which allows real-time non-invasive analysis of more than 1,000 swimming tadpoles simultaneously.

The TadPool evaluates each tadpoles decision-making skills, ability to learn, swimming patterns, and circadian rhythms to produce a multidimensional picture of their behavior. Comparing these behaviors with and without a given drug indicates whether the drug effectively reverses the features of the disease. Drug screening results then feed back into NeMoCAD in an iterative process to identify drug targets that underlie successful treatment, which can be used to develop even more effective new drugs.

Components of the CogniXense platform are being further developed at the Wyss Institute, and are being used in its Biostasis and CircaVent projects.

Treat the patient, treat the disease

Based on CogniXenses success in the lab, Unravel was launched to commercialize the technology. The company has customized it to create their proprietary BioNAV platform, which incorporates transcriptome and proteome data from patients.

By using real patient data, we ensure that our predictive algorithms actually identify drugs that can treat a disease in a person who suffers from it. When we repeat this process for multiple patients across the spectrum of neurologic diseases and look at that combined information, we can pinpoint drugs that will work for certain groups of patients regardless of their formal clinical diagnosis or genetic mutations. So, were applying a personalized medicine approach across conditions that were previously considered independent of each other to identify effective treatments for the more than 15,000 patients who suffer from rare diseases, said Frederic Vigneault, Ph.D., a former Senior Staff Scientist at the Wyss Institute who is now the CSO and co-founder of Unravel. And, if no existing drugs can effectively treat a particular population, we use our platform to design new ones.

In July 2022, Unravel announced a partnership with TMA Precision Health (TMA) to leverage TMAs database of patients with rare diseases in regions across the globe that have historically been underrepresented in medical research. The companies are aiming to use this patient access to bring Unravels first drug candidate, a proprietary oral liquid formulation for the treatment of Rett Syndrome, to clinical trials by the end of 2022.

Unravel plans to pursue multiple rare disorders in parallel, building on the rapid clinical translation of their Rett syndrome program. The company is partnering with academic and industry groups to use patient transcriptome data to redefine how rare diseases are treated and enable effective therapies to reach patients in need more quickly.

You hear a lot about how artificial intelligence is going to impact drug discovery, but examples of success are few and far between. I am extremely proud of this team for their ability to collaborate across disciplines and to develop this powerful first-of-its-kind drug discovery platform that combines computation with experimentation in an iterative way that is absolutely critical for clinical success, as well as their determination to spin it out into a company as quickly as possible to maximize its impact. Unravel is a perfect example of how pursuit of academic innovation with an entrepreneurial mindset can lead to development of disruptive technologies that can change the world for the better, said Ingber, [BL1]who is also the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Childrens Hospital, and the Hansjrg Wyss Professor of Bioinspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.

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Novavax Makes One Million Doses of Nuvaxovid Available for Use in the United Kingdom

GAITHERSBURG, Md., Sept. 27, 2022 /PRNewswire/ --Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announcedthat an initial one million doses of Nuvaxovid (NVX-CoV2373)COVID-19 vaccine are now available for use in the United Kingdom (U.K.). Nuvaxovid is the first protein-based COVID-19 vaccine granted authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) and will be offered per the Joint Committee on Vaccination and Immunisation (JCVI) advice.

"With U.K. data showing that people infected with both COVID-19 and the flu are more than five times as likely to die compared to someone with no infection1, it is more important than ever to consider any vaccine offered to you by the National Health Service," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We continue to believe in the importance of a diversified national vaccine portfolio to reduce winter pressures on the health service."

Nuvaxovid was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The MHRA granted Conditional Marketing Authorization (CMA) for Nuvaxovid's use as a two-dose primary series vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 18 and olderin February 2022,and in adolescents aged 12 through 17 in August 2022. Novavax submitted a request to the MHRA for expanded CMA of Nuvaxovid as a booster in adults aged 18 and older on June 1, 2022 and is awaiting a decision from the agency.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

Trade Name in the U.S. The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information: UK

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

About Nuvaxovid (NVX-CoV2373)Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (thePRE-fusion protein subunitVaccineEfficacyNovavaxTrial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations inthe U.S.andMexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S.Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published inNEJM.

About Matrix-M AdjuvantNovavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About NovavaxNovavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza Combination vaccine candidate in a Phase 1/2 clinical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit http://www.novavax.com and connect with us on LinkedIn.

Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373, NVX-CoV2515 and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza combination investigational vaccine candidate, its quadrivalent influenza investigational vaccine candidate,Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain,the scope, timing and outcome of future regulatory filings and actions, including potential recommendations and authorizations from the MHRA, JCVI or any other regulatory authority, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; unanticipated challenges or delays in conducting clinical trials; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; the emergence of variants of the SARS-CoV-2 virus that may negatively impact market acceptance or anticipated sales of NVX-CoV-2373; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this statement. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this statement speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

References

Contacts:

InvestorsErika Schultz | 240-268-2022ir@novavax.com

MediaAli Chartan or Giovanna Chandler | 202-709-5563 media@novavax.com

SOURCE Novavax, Inc.

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Novavax Makes One Million Doses of Nuvaxovid Available for Use in the United Kingdom - Novavax Investor Relations