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Category Archives: Genetic Engineering

CRISPR Technology in the Agricultural Industry: Patent and Regulatory Updates – JD Supra

Posted: August 5, 2022 at 2:20 am

Introduction

The ability to edit eukaryotic DNA entails an almost limitless ability to alter the genetic makeup of the plants that become our food. Recently, scientific attention has been directed to applying a class of new gene-editing techniques that utilize CRISPR to food crops for the introduction of commercially desirable traits. Gene-edited crops can have a positive impact on food productivity, quality, and environmental sustainability, and CRISPR is unique in its relative simplicity, robust flexibility, cost-effectiveness, and wide scope of use. The increased use of CRISPR in agriculture has endless applications, the consequences of which are only recently being analyzed.

CRISPR & the Power of Gene Editing

The term CRISPR refers generally to a class of gene-editing mechanisms derived from prokaryotic immune systems. These mechanisms feature two main components: guiding RNA molecules that direct the second component, CRISPR-associated ("Cas") proteins, to the target region of cellular DNA. These Cas proteins induce a double-stranded break in the DNA and allow for targeted manipulation of the desired genetic code. There is incredible diversity in the CRISPR-Cas system and a multitude of different Cas proteins that can be fine-tuned to induce desired changes with high specificityincluding the activation or deactivation of individual genes, or the insertion of genes from other organisms into the target genome.

CRISPR's flexibility stands in sharp contrast to the previous generation of gene-editing technologies, such as Zinc Finger Nucleases and Transcription Activator-Like Effector Nucleases ("TALENs"), which require massive amounts of preemptive research and development and have a far more limited scope of use. This simultaneous precision and flexibility therefore provides ample opportunity for gene-edited optimization of food crops and has already been used in some instances to create, for example, browning-resistant mushrooms. In late 2021, in Japan, the first CRISPR-edited food product was introduced to the global market: tomatoes with high levels of GABA, a naturally occurring neurotransmitter, due to a CRISPR-inactivated gene.

The power of CRISPR has incredible potential for innovation, but the rights and regulations associated with CRISPR have been elusive and, at times, contentious. CRISPR's game-changing technology was the subject of a series of patent priority, inventorship, and, hence, ownership disputes between high-profile research institutionsthe recent results of which have significant implications for global food supplies.

Patent Landscape

Like most cutting-edge technologies, the invention of CRISPR was accompanied by a flurry of patent application filings in the United States and elsewhere, as researchers who brought CRISPR to light sought to protect and monetize their rights as inventors. Numerous academic institutionsincluding Harvard's and MIT's Broad Institute, the University of California, University of Vienna, Vilnius University, The Rockefeller University, and companies such as ToolGen, Inc., Sigma-Aldrich (Millipore Sigma), Caribou Biosciences, Inc., Editas Medicine, Inc., Keygene N.V., Depixus, Blueallele Corp., and CRISPR Therapeutics AG, among numerous other institutions and companieshave secured U.S. and foreign patent rights related to the applications of CRISPR technology. As CRISPR continues to expand in use, especially in the case of CRISPR-edited agriculture that evade many regulations other GMO foods cannot, the complexity of the patent landscape will almost certainly continue to grow.

EU Regulatory Landscape

In general, the EU subjects agricultural products edited with CRISPR technology to the full suite of genetically modified organism ("GMO") premarket approval, safety, and labeling requirements. The primary EU regulation on point, Directive 2001/18/EC (the "GMO Directive"), was promulgated in 2001 by the European Parliament and Council of the European Union. The GMO Directive requires all EU Member States to create appropriate precautionary measures regarding the release of GMOs in the market. However, the definition of GMO in the GMO Directive apparently excludes CRISPR modification, stating that a GMO is as "an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination."

It was not until 2018 that the EU addressed this gap in the GMO Directive. In July 2018, the Court of Justice of the European Union explained in Case C-528/16 that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive. "Only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive."

The following year, in November 2019, the Council of the EU formally requested that the European Commission "submit a study in light of the Court of Justice's judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study." The 117-page study was issued in April 2021, and ultimately affirms the holding in Case C-528/16, stating that the "study makes it clear that organisms obtained through new genomic techniques [including CRISPR] are subject to the GMO legislation." Based on the study's findings, the European Commission requested public input on proposed legislation for "plants obtained by targeted mutagenesis and cisgenesis and for their food and feed products." The public consultation period expired on July 22, 2022. The European Commission plans to finalize the proposed framework in 2023.

United States Regulatory Landscape

In contrast to the EU approach, the United States does not currently regulate CRISPR-edited agricultural products as GMOs. The United States regulates biotechnology and genetic modification in food through a "Coordinated Framework" between the U.S. Department of Agriculture ("USDA"), Food and Drug Administration ("FDA"), and Environmental Protection Agency ("EPA").

At a high level, the USDA regulates the use of biotechnology in plant products through the Plant Protection Act. The USDA explains that the Plant Protection Act provides the USDA's Animal and Plant Health Inspection Service ("APHIS") with authority to regulate "organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering." Further, in 2018, the USDA's Agricultural Marketing Service promulgated the National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (the "BE Disclosure Standard"), which created a "new national mandatory bioengineered [] food disclosure standard" and associated recordkeeping requirements, effective January 1, 2022. The BE Disclosure Standard defines bioengineered food as food products that contain "genetic material that has been modified through in vitro [DNA]" and "for which the modification could not otherwise be obtained through conventional breeding or found in nature." Notably, the USDA has not explicitly clarified whether CRISPR-edited agricultural products are considered "bioengineered foods" and subject to the BE Disclosure Standard. Rather, in a presentation from 2020, the USDA stated that it "intends to make determinations about whether a specific modifications would be considered 'found in nature' or obtained through 'conventional breeding' on a case-by-case basis." (For more information on the BE Disclosure Standard, refer to Jones Day's May 2022 publication, Are Your Labels Up to Date? Assuring Compliance with the USDA's National Bioengineered Food Disclosure Standard.)

Additionally, the FDA regulates the use of biotechnology in plants with a focus on ensuring that foods are safe for human consumption. In 1992, the FDA issued a Statement of Policy regarding Foods Derived from New Plant Varieties, in which the FDA stated that "[t]he regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components)." Since then, the FDA has reviewed genetic modifications to food in the context of food additives, such that FDA approval is required to use food additives unless it is generally recognized as safe ("GRAS"). In the opinion of the FDA, a GMO is not GRAS if the altered substance "differs significantly in structure, function or composition from substances found currently in food." In contrast, a GMO is GRAS if it is "naturally occurring" in the food product, even if is bioengineered to be present at a "greater level" than found in nature or if there are "minor variations in molecular structure that do not affect safety." As explained in the introduction, CRISPR technology differs from conventional gene editing because it does not introduce new substances into a product that are not naturally present. Accordingly, CRISPR-edited agricultural products are not generally regulated by the FDA as food additives.

The EPA also reviews the use of biotechnology in plants, as it regulates the distribution, sale, and use of pesticides to ensure that they will "not pose unreasonable risks to human health or the environment when used according to label directions." Further, when the EPA evaluates plant-incorporated protectants ("PIPs"), which are genetically engineered pesticides, the EPA "requires extensive studies containing numerous factors, such as risks to human health, nontarget organisms, and the environment; potential for gene flow; and the need for insect resistance management plans." As such, CRISPR-edited pesticides may be regulated by the EPA as PIPs.

Conclusion

The patent and regulatory landscapes of the use of CRISPR technology in food are continuing to unfold across the world. Accordingly, agriculture companies and the broader agricultural industry should pay close attention to all developments.

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Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11…

Posted: August 5, 2022 at 2:20 am

GAITHERSBURG, Md., Aug. 4, 2022 /PRNewswire/ -- Novavax,Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the initiation of its Phase 2b/3 Hummingbird global clinical trial. The trial will evaluate the safety, effectiveness (immunogenicity), and efficacy of two doses of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children aged six months through 11 years, followed by a booster at six months after the primary vaccination series.

"We are excited to begin the Hummingbird trial to study Nuvaxovid's efficacy in children as young as six months through age 11," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With a successful trial, we may have the opportunity to offer our COVID-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic."

The trial will assess the Novavax COVID-19 vaccine in infants (six through 23 months of age), toddlers (two through five years) and children (six through 11 years). The trial is an age de-escalation trial and age groups will be tested sequentially. Participants have begun dosing in the six to 11-year-old age group. The trial will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.

The trial will seek to enroll 3,600 participants in the US, Mexico, Colombia, Argentina, Spain, UK, South Africa, Philippines, and Brazil. Initial results are expected in Q1 2023.

About the Novavax COVID-19 vaccine (NVX-CoV2373)

The Novavax COVID-19 vaccine (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. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The Novavax COVID-19 vaccine 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 its COVID-19 vaccine 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 Matrix-M Adjuvant

Novavax' 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 Novavax

Novavax, 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., EC 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 a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent 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, visitwww.novavax.comand connect with us on LinkedIn.

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza investigational combination vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID-19 pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety and intended utilization of NVX-CoV2373, 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; 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; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; 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 press release. You are encouraged to read our filings with the SEC, available at http://www.sec.govand http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release 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.

Contacts:

InvestorsErika Schultz | 240-268-2022[emailprotected]

MediaAli Chartan or Giovanna Chandler | 202-709-5563[emailprotected]

SOURCE Novavax, Inc.

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They’re From Argentina, And They’re One Of The Few Labs That’s Been Able To Eliminate THC From Cannabis With Gene Editing. – Nation World News

Posted: August 5, 2022 at 2:20 am

three Entrepreneurs got the tool to remove them cannabis his main psychoactive ingredientThe tetrahydrocannabinol (THC), and managed to figure it out start up among first laboratory In the world to obtain genetically edited variants capable of applying this technology to this crop that could avoid millionaire losses in an industry that goes beyond pharmaceutical use.

Two Biotechnologists and an Economist Tool managed to design reproductive engineering It acts like a biological scissor inspired by an Antarctic bacterium, modifying the genome of cannabis and allow to obtain better plants for medicinal and industrial applications.

We are the first Argentine laboratory that managed to efficiently edit the cannabis genome at an experimental level, with reporter proteins that allow us to monitor the efficiency of the process, he says. Ramiro OliveiraAnimal Biotechnology Expert and CEO biotech chalisa, Created and incubated by company scientists National University of San Martin (that).

stick up for Stephen Hernandoexperts in plant biotechnology, and Alexander Germe, Director of Finance and Project Strategy. The Biotechnological Research Institute of Unsam is located on the Miguelet campus start up Account from last year with authorization from coniset And this national health ministry For your research and development projects with the cannabis plant.

In Argentina, according to Oliveira, they had not yet started applying. biotechnology equipment for the improvement of this plant. The cannabis revolution in the world through biotechnology. It is an industry that is growing rapidly and prohibitionism meant that this crop was not studied scientifically in the world: sooner or later, it will be like another crop of agricultural value, the researchers explain. . We understood this and decided to become a leader in the development of sophisticated tools that allow us to solve problems that are already representative in the industry today. For example, high levels of THC This is causing huge losses to the industrial cannabis growers.

By regulation, the THC level of the cannabis plant cannabis sativa For the manufacture of products for medicinal or pharmaceutical use it cannot exceed 0.3%. Above that value, it is considered a crop with psychoactive properties. The plant naturally expresses a higher percentage of THC than is allowed and must be subjected to complex extraction processes to eliminate this cannabinoid with a high cost.

These genetically edited crops will be the solution to the problem that generates millionaire losers for the industry and will position us as a benchmark in biotechnology applied to this crop, says Oliveira.

With previous experience in highly complex biotechnology projects, such as the cloning of horses and improvements with genetic engineering of crops such as soybeans, wheat and alfalfa, the team has since last year focused on their new venture, the main objective of which is to : Developing them based on technology known as own gene editing tools CRISPR-Cas9 To be able to optimize the properties of the plant. with them biological scissors, the researchers claim they can edit DNA precisely and efficiently.

The first step was to identify the gene that needed to be worked on. In this case, it is associated with the presence of THC in the plant. The team then designed biological scissors to introduce into the plant: an enzyme that cuts d n With a ribonucleic acid guide (arn) to accurately orient the region of the genome to modify it.

We apply an editing strategy in which genetic material from outside the plant is not used. For that we separate the cells from the plants and remove their cell wall. These cells (protoplasts) co-incubate with enzymes and guide [de ARN] To carry out editing, which aims to disrupt and lose its function as the gene responsible for THC synthesis. This makes it possible to produce better plants, without being considered transgenic, explains Oliveira. Country, Once these edited cells are obtained, they are selected and reproduced in a new plant through in vitro culture [en pequeos recipientes con agar rico en hormonas y nutrientes], In the greenhouse, they are molecularly evaluated to check their growth success.

Laboratory tests showed that they were able to fine-tune that process by effectively modifying genome From the cannabis plant. This confirms that our technology works and is a great step forward in science and technology for Argentina. It is a great progress both in the country and in the region that will allow us to think about improvements in other developments productive interest for this harvest, highlights Oliveira.

The team argues that the tool has no limits, as it also allows you to boost the level of others. cannabinoid Plants that are expressed in low concentrations but which have high healing potential and have not yet been studied due to difficulties in purifying them in quantities. It also makes it possible to regulate the ratio of different cannabinoids to their use. medicine or cosmeticsAs medical research advances in defining dosage limits.

Points to development of another application that the team oversees industrial hemp, It is anticipated that hemp fiber will compete with cotton in a few years, predict the entrepreneurs, who are seeing potential demand from other industries in the world. In that case, the cannabis industry will demand better plants that can be applied to comprehensive management. The tools we develop serve to produce plants that are more resistant to inclement weather and pathogens. With these technologies, we will be able to develop non-transgenic plants that are more productive, efficient in use of resources and with lower production costs.

Last month, ahead of a presentation by the team, National Commission on Agricultural Technology (Konabia) informed them that the development of THC-free plant varieties with CRISPR-Cas9 technology is not considered transgenic. This means that these plants can be on the market quickly in two or three years. This not only guarantees the safety of this type of crop, but also saves the company between 50 and 100 million dollars, which It will be necessary to regulate and market a crop considered to be transgenic, concludes the team.

For this project, the team received financial support from ministry of producer development And this Under Secretary of the Knowledge Economy,

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Stephen Hawking says ‘superhumans’ could threaten the future of humanity – Ohmymag

Posted: August 5, 2022 at 2:20 am

Updated on August 4, 2022 at 10:23 AM

In his last book, the late scientist Stephen Hawking warned of the dangers of genetic engineering. According to him, this field of research could threaten the future of humanity.

In his final book, the renowned scientist Stephen Hawking, one of the most brilliant minds of his generation, warned of the dangers of CRISPR and genetic engineering for human evolution.

In his latest - posthumous - book Brief Answers to Big Questions, Stephen Hawking offers his predictions on the future of humanity, the laws of the universe, and everything else. Is time travel possible? Should we colonise space? Does God exist? Or how do we shape the future?

Amongst these thoughts, Hawking warns of the dangers of genetic engineering:

According to Hawking, the first steps in this new phase will be limited to repairing genetic defects. More comprehensive and complex modifications, such as optimising our intelligence or physics, will take more time and energy before they can be implemented. However, we are not immune to the adverse effects of such possibilities.

Hawking fears that as this technology evolves and permeates society, it will become a source of division between human beings.

The elites who benefit from this eugenics - described by Hawking as superhumans - could directly oppose the rest of humanity in a quest for supremacy that would dictate the future management of the planet.

He explains:

According to Hawking, if they are not destined to disappear, they will probably no longer be considered worthy of interest and will find themselves at the back of humanity which is modifying its own characteristics at an ever-increasing rate.

While these predictions may seem, alarmist, they are not new to researchers working on gene-editing technologies like CRISPR. At a time when the future of the planet and the future of humans is at stake, it would be better to look at what unites us.

This article was translated from Gentside FR.

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$964 Billion Worldwide Biotechnology Industry to 2027 – Featuring Amgen, Biogen, Novartis and Pfizer Among Others – ResearchAndMarkets.com – Business…

Posted: August 5, 2022 at 2:20 am

DUBLIN--(BUSINESS WIRE)--The "Biotechnology Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

The global biotechnology market reached a value of US$ 617.98 Billion in 2021. Looking forward, the publisher expects the market to reach a value of US$ 964.96 Billion by 2027, exhibiting a CAGR of 7.71% during 2021-2027.

Companies Mentioned

Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.

Biotechnology refers to the utilization of biological processes and living organisms to modify different products and services for a specific application. One such application includes the production of therapeutic proteins and other drugs through genetic engineering. Biotechnology is employed in the agriculture sector for growing genetically modified plants, improving pest resistance, enhancing crop herbicide tolerance, and facilitating sustainable farming. Moreover, it is gaining traction in wastewater treatment, chemical manufacturing, paper, textiles, and food products, and reducing the environmental footprint of industrial processes and making them cleaner as well as more efficient.

With the increasing food scarcity on account of the growing global population, there is a significant rise in the demand for biotechnology to enhance crop yield. Moreover, the increasing adoption of sustainable manufacturing methods is contributing to the market growth.

Apart from this, the application of biotechnology is expanding in the healthcare sector. It is used in stem cell research and cloning techniques for replacing defective cells and tissues in regenerative medicine. Furthermore, the increasing focus on finding molecular root causes of diseases is encouraging investments in research and development (R&D) activities in the field of biotechnology.

These activities will enable the production of therapeutic proteins and the improvement of existing pharmaceuticals and monoclonal antibodies, which can stop the disease progression. The need for biotechnology is further escalating for finding potential treatments of coronavirus disease (COVID-19). Besides this, the increasing demand for biofuels due to the strict emission regulations set by governing agencies worldwide is anticipated to influence the market growth.

Key Questions Answered in This Report:

Key Topics Covered:

1 Preface

2 Scope and Methodology

3 Executive Summary

4 Introduction

4.1 Overview

4.2 Key Industry Trends

5 Global Biotechnology Market

5.1 Market Overview

5.2 Market Performance

5.3 Impact of COVID-19

5.4 Market Forecast

6 Market Breakup by Product Type

7 Market Breakup by Technology

8 Market Breakup by Application

9 Market Breakup by Region

10 SWOT Analysis

11 Value Chain Analysis

12 Porters Five Forces Analysis

13 Price Analysis

14 Competitive Landscape

14.1 Market Structure

14.2 Key Players

14.3 Profiles of Key Players

For more information about this report visit https://www.researchandmarkets.com/r/xzscm3

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$964 Billion Worldwide Biotechnology Industry to 2027 - Featuring Amgen, Biogen, Novartis and Pfizer Among Others - ResearchAndMarkets.com - Business...

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POSEIDA THERAPEUTICS, INC. : Results of Operations and Financial Condition, Other Events (form 8-K) – Marketscreener.com

Posted: August 5, 2022 at 2:20 am

Item 2.02 Results of Operations and Financial Condition.

On August 3, 2022, Poseida Therapeutics, Inc. (the "Company," "we," "us" and"our") filed a preliminary prospectus supplement with the Securities andExchange Commission (the "SEC") in which we disclosed that, based on currentlyavailable information, we expect our cash, cash equivalents and short-terminvestments as of June 30, 2022 to be approximately $142.6 million.

The preliminary results set forth above are based on management's initial reviewof our operations for the quarter ended June 30, 2022 and are subject tocompletion of financial closing procedures. The preliminary financial results inthis Item 2.02 have been prepared by, and are the responsibility of management.Actual results may differ materially from these preliminary results as a resultof the completion of financial closing procedures, final adjustments, and otherdevelopments arising between now and the time that our financial results arefinalized. In addition, these preliminary results are not a comprehensivestatement of our financial results for the quarter ended June 30, 2022, shouldnot be viewed as a substitute for full financial statements prepared inaccordance with generally accepted accounting principles, and are notnecessarily indicative of our results for any future period.PricewaterhouseCoopers LLP has not audited, reviewed, compiled, or appliedagreed-upon procedures with respect to the preliminary financial results.Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any otherform of assurance with respect thereto.

Item 8.01 Other Events.

We are filing the following information for the purpose of supplementing andupdating certain disclosures contained in our prior filings with the SEC,including those discussed under the heading "Risk Factors" in our most recentQuarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed withthe SEC on May 12, 2022 (the "Quarterly Report") and certain aspects of ourpublicly disclosed description of our business contained in our other filingswith the SEC.

Company Overview

We are a clinical-stage biopharmaceutical company dedicated to utilizing ourproprietary genetic engineering platform technologies to create next-generationcell and gene therapeutics with the capacity to cure. We have discovered and aredeveloping a broad portfolio of product candidates in a variety of indicationsbased on our core proprietary platforms, including our non-viral piggyBac DNADelivery System, Cas-CLOVER Site-specific Gene Editing System and nanoparticleand AAV-based gene delivery technologies. Our core platform technologies haveutility, either alone or in combination, across many cell and gene therapeuticmodalities and enable us to engineer our portfolio of product candidates thatare designed to overcome the primary limitations of current generation cell andgene therapeutics.

Within cell therapy, we believe our technologies allow us to create productcandidates with engineered cells that engraft in the patient's body and drivelasting durable responses that may have the capacity to result in singletreatment cures. Our CAR-T therapy portfolio consists of both autologous andallogeneic, or off-the-shelf, product candidates. We are advancing a broadpipeline and have multiple CAR-T product candidates in the clinical phase inboth hematological and solid tumor oncology indications. Within gene therapy, webelieve our technologies have the potential to create next-generation therapiesthat can deliver long-term, stable gene expression that does not diminish overtime and that may have the capacity to result in single treatment cures.

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CAR-T for Oncology

The following table summarizes our current CAR-T for oncology product candidateportfolio, including a representation of programs that we partnered with F.Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively "Roche") in July2022:

Our most advanced investigational clinical programs are:

We manufacture these product candidates using our non-viral piggyBac DNADelivery System. Our fully allogeneic CAR-T product candidates are developedusing well-characterized cells derived from a healthy donor as starting materialwith the goal of enabling treatment of potentially hundreds of patients from asingle manufacturing run. Doses are cryopreserved and stored at treatmentcenters for future off-the-shelf use. In addition, our allogeneic productcandidates use our proprietary Cas-CLOVER Site-specific Gene Editing System toreduce or eliminate reactivity, as well as our booster molecule technology formanufacturing scalability.

Our most advanced preclinical cell therapy program is:

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Gene Therapy

Our gene therapy product candidates have been developed by utilizing ourpiggyBac technology together with AAV to overcome the major limitations oftraditional AAV gene therapy. We believe that our approach can result inintegration and long-term stable expression at potentially much lower doses thanAAV technology alone, thus also conferring cost and tolerability benefits. Oureventual goal is to completely replace AAV with our non-viral nanoparticletechnology, freeing future product development in gene therapy of AAVlimitations.

The following table summarizes our current gene therapy product candidateportfolio including a representation of programs that we partnered with TakedaPharmaceuticals USA, Inc. (Takeda) in October 2021:

Our most advanced gene therapy programs are:

We expect our expenses and losses to increase substantially for the foreseeablefuture as we continue our development of, and seek regulatory approvals for, ourproduct candidates, including P-PSMA-101 and P-MUC1C-ALLO1, and begin tocommercialize any approved products. While we anticipate an overall increase indevelopment costs as we continue to expand the number of product candidates inour pipeline and pursue clinical development of those candidates, we expect adecrease in our development costs on a per program basis as we are transitioningto our allogeneic platform. In addition, all or some of the development costsrelated to partnered gene therapy programs and cell therapy programs will bereimbursed by Takeda and Roche, respectively. We also expect our general andadministrative expenses will increase for the foreseeable future to support ourincreased research and

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development and other corporate activities. Our net losses may fluctuatesignificantly from quarter-to-quarter and year-to-year, depending on the timingof our clinical trials and our expenditures on other research and developmentactivities.

We do not expect to generate any revenues from product sales unless and until wesuccessfully complete development and obtain regulatory approval for P-PSMA-101and P-MUC1C-ALLO1, or any other product candidates, which will not be for atleast the next several years, if ever. If we obtain regulatory approval for anyof our product candidates, we expect to incur significant commercializationexpenses related to product sales, marketing, manufacturing and distributionactivities. Accordingly, until such time, if ever, as we can generatesubstantial product revenue, we expect to finance our operations through equityofferings, debt financings or other capital sources, including potential grants,collaborations, licenses or other similar arrangements.

However, we may not be able to secure additional financing or enter into suchother arrangements in a timely manner or on favorable terms, if at all. Therecan be no assurances that we will be able to secure such additional sources offunds to support our operations, or, if such funds are available to us, thatsuch additional financing will be sufficient to meet our needs. Our failure toraise capital or enter into such other arrangements when needed would have anegative impact on our financial condition and could force us to delay, reduceor terminate our research and development programs or other operations, or grantrights to develop and market product candidates that we would otherwise preferto develop and market ourselves.

The manufacturing process for our allogeneic product candidates is nearlyidentical to the process for our autologous product candidates, except for thegene editing and related steps. We work with a number of third-party contractmanufacturing organizations for production of our product candidates. We alsowork with a variety of suppliers to provide our manufacturing raw materialsincluding media, DNA and RNA components. We have completed construction of aninternal pilot GMP manufacturing facility in San Diego, California adjacent toour headquarters to develop and manufacture preclinical materials and clinicalsupplies of our product candidates for Phase 1 and Phase 2 clinical trials inthe future. We commenced GMP activity in the third quarter of 2021, however weexpect that we will continue to rely on third parties for various manufacturingneeds. In the future, we may also build one or more commercial manufacturingfacilities for any approved product candidates.

An investment in our common stock is speculative and involves a high degree ofrisk. Our business, reputation, results of operations and financial condition,as well as the price of our common stock, can be affected by a number offactors, whether currently known or unknown, including those described under theheading "Risk Factors" of our Quarterly Report. If any of such risks occur, ourbusiness, financial condition, results of operations and future growth prospectscould be materially and adversely affected. In these circumstances, the marketprice of our common stock could decline, and you may lose all or part of yourinvestment. Below are certain changes to our risk factors included in theQuarterly Report.

Risks Related to Our In-Licenses and Other Strategic Agreements

We may not realize the benefits of any acquisitions, in-license or strategicalliances that we enter into or fail to capitalize on programs that may presenta greater commercial opportunity or for which there is a greater likelihood ofsuccess.

Our business depends upon our ability to identify, develop and commercializeresearch programs or product candidates. A key element of our business strategyis to discover and develop additional programs based upon our core proprietaryplatforms, including our non-viral piggyBac DNA Delivery System, Cas-CLOVERSite-specific Gene Editing System and nanoparticle- and AAV-based gene deliverytechnologies. In addition to internal research and development efforts, we arealso seeking to do so through strategic collaborations, such as ourcollaborations with Roche and Takeda, and may also explore additional strategiccollaborations for the discovery of new programs. We have also entered intoin-license agreements with multiple licensors and in the future may seek toenter into acquisitions or additional licensing arrangements with third partiesthat we believe will complement or augment our existing technologies and productcandidates.

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These transactions can entail numerous operational and financial risks,including exposure to unknown liabilities, disruption of our business anddiversion of our management's time and attention in order to manage acollaboration or develop acquired products, product candidates or technologies,incurrence of substantial debt or dilutive issuances of equity securities to paytransaction consideration or costs, higher than expected development ormanufacturing costs, higher than expected personnel and other resourcecommitments, higher than expected collaboration, acquisition or integrationcosts, write-downs of assets or goodwill or impairment charges, increasedamortization expenses, difficulty and cost in facilitating the collaboration orcombining the operations and personnel of any acquired business, impairment ofrelationships with key suppliers, manufacturers or customers of any acquiredbusiness due to changes in management and ownership and the inability to retainkey employees of any acquired business. As a result, if we enter intoacquisition or in-license agreements or strategic partnerships, we may not beable to realize the benefit of such transactions if we are unable tosuccessfully integrate them with our existing operations and company culture, orif there are materially adverse impacts on our or the counterparty's operationsresulting from COVID-19, which could delay our timelines or otherwise adverselyaffect our business. Further, because we have limited resources, we must chooseto pursue and fund the development of specific types of treatment, or treatmentfor a specific type of cancer, and we may forego or delay pursuit ofopportunities with certain programs or products or for indications that laterprove to have greater commercial potential. Our estimates regarding thepotential market for our program could be inaccurate, and if we do notaccurately evaluate the commercial potential for a particular program, we mayrelinquish valuable rights to that program through a strategic collaboration,licensing or other arrangements in cases in which it would have been moreadvantageous for us to retain sole development and commercialization rights tosuch program. Alternatively, we may allocate internal resources to a program inwhich it would have been more advantageous to enter into a partneringarrangement. If any of these events occur, we may be forced to abandon or delayour development efforts with respect to a particular product candidate or failto develop a potentially successful program.

Our collaborators may not devote sufficient resources to the development orcommercialization of our product candidates or may otherwise fail in developmentor commercialization efforts, which could adversely affect our ability todevelop or commercialize certain of our product candidates and our financialcondition and operating results.

We have, with respect to our collaborations with Roche and Takeda, and willlikely have, with respect to any additional collaboration arrangements with anythird parties, limited control over the amount and timing of resources that ourcollaborators dedicate to the development or commercialization of our productcandidates. For example, while we expect to collaborate with Takeda on thedevelopment of up to six in vivo gene therapy programs, only two such programshave been designated by Takeda and we cannot guarantee that Takeda will elect topursue development of additional gene therapy programs under the collaboration.Similarly, while we expect to collaborate with Roche on the development of up toten allogeneic CAR-T cell therapy programs and have granted to Roche an optionto acquire licenses under certain of our intellectual property to develop,manufacture and commercialize products for up to three solid tumor targets, onlytwo such programs have been designated by Roche and we cannot guarantee thatRoche will elect to pursue development of additional cell therapy programs underthe Roche Collaboration Agreement. In each case, a decision by Roche or Takedato pursue less than the maximum number of targets or programs available forcollaboration under their respective collaboration agreements will limit thepotential payments we may receive under such collaboration agreements, delay ourdevelopment timelines or otherwise adversely affect our business. In general,our ability to generate revenues from these arrangements will depend on ourcollaborators' abilities to successfully perform the functions assigned to themin these arrangements and otherwise to comply with their contractualobligations.

Any of our existing or future collaborations may not ultimately be successful,which could have a negative impact on our business, results of operations,financial condition and growth prospects. In addition, the terms of any suchcollaboration or other arrangement may not prove to be favorable to us or maynot be perceived as favorable, which may negatively impact the trading price ofour common stock. In some cases, we may be responsible for continuingdevelopment or manufacture of a product or product candidate or research programunder collaboration and the payment we receive from our partner may beinsufficient to cover the cost of this development or manufacture. For example,under the Takeda Collaboration Agreement, we are obligated to perform certainplatform development activities at our own cost. In addition, under the RocheCollaboration Agreement, while Roche is obligated to reimburse us for aspecified percentage of certain costs incurred in performance of developmentactivities relating to P-BCMA-ALLO1 and P-CD19CD20-ALLO1, we will be responsiblefor the balance and the amount Roche is obligated to reimburse us is subject toa maximum cap.

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Conflicts may arise between us and our collaborators, such as conflictsconcerning the interpretation of clinical data, the achievement of milestones,the division of development responsibilities or expenses, development plans, theinterpretation of financial provisions, or the ownership of intellectualproperty developed during the collaboration. If any such conflicts arise, acollaborator could act in its own self-interest, which may be adverse to ourbest interests. Any such disagreement between us and a collaborator could delayor prevent the development or commercialization of our product candidates.

Further, we are subject to the following additional risks associated with ourcurrent and any future collaborations with third parties, the occurrence ofwhich could cause our collaboration arrangements to fail:

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Forward-Looking Statements

Statements contained in this Current Report regarding matters that are nothistorical facts are "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995. Such forward-lookingstatements include statements regarding development activities under thecollaboration agreements; our expectations regarding the timing, scope andresults of our development activities, including our ongoing and plannedclinical trials; the timing of and plans for regulatory filings; the potentialbenefits of our product candidates and technologies; our expectations regardingthe use of our platform technologies to generate novel product candidates; themarket opportunities for our product candidates and our ability to maximizethose opportunities; our business strategies and goals; estimates of our cashbalance, expenses, capital requirements, any future revenue, and need foradditional financing; our expectations regarding manufacturing capabilities andplans; the performance of, and reliance on, our third-party suppliers andmanufacturers; our ability to attract and/or retain new and existingcollaborators with development, regulatory, manufacturing and commercializationexpertise and our expectations regarding the potential benefits to be derivedfrom such collaborations; the sufficiency of our existing cash and cashequivalents to fund our operations; and future events and uncertaintiesdescribed under the "Risk Factors" heading of this Current Report. In somecases, you can identify forward-looking statements because they contain wordssuch as "anticipate," "believe," "contemplate," "continue," "could," "estimate,""expect," "intend," "may," "plan," "potential," "predict," "project," "should,""target," "will" or "would" or the negative of these words or other similarterms or expressions. Because such statements are subject to risks anduncertainties, actual results may differ materially from those expressed orimplied by such forward-looking statements. These forward-looking statements arebased upon our current expectations and involve assumptions that may nevermaterialize or may prove to be incorrect. Actual results could differ materiallyfrom those anticipated in such forward-looking statements as a result of variousrisks and uncertainties, which include, without limitation, the fact that theRoche Collaboration Agreement may not become effective based onHart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, clearance, orthe effectiveness may be substantially delayed; our collaboration agreements may. . .

Edgar Online, source Glimpses

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China’s apologists again try to cover up Wuhan lab leak of Covid-19 – The Sunday Guardian Live – The Sunday Guardian

Posted: August 5, 2022 at 2:20 am

Renewed efforts are being made to cover up the origin of Wuhan virus.

Bengaluru: As a defeat by the Democratic Party in the mid-term elections in the United States this year appears to be a certainty, and as possibility increases of the Republicans coming to control the US House of Representatives, the prospects of a Congressional hearing/investigation into the origin of the Wuhan virus, also known as Covid-19, are a given. To head off a possible Congressional probe, the cast of US characters involved in the research and development of this genetically engineered virus that has killed millions all over the globe, is back to obfuscating the source of the virusChinas Wuhan Institute of Virology (WIV)by calling it a natural virus in a bid to whitewash their own and the Xi Jinping regimes culpability. This is apparent from the publishing of two articles on 26 July 2022, in the journal Science. Both these articles have multiple authors under Dr Kristian G. Andersens guidance in the US. Andersen is known for infamously switching from suspecting Covid-19 to be genetically engineered, to trying to prove that it naturally jumped from wild bats to humans. These two latest studies further prove that Covid-19 originated in Wuhan, but do not prove the zoonotic (jumping from animals to humans) origin of the virus that the authors are at pains to prove, based on numerous assumptions. Co-conspirators in the diversion of large US research funds tothe WIV in China ensured the suppression of facts and orchestrated the publication of misleading scientific correspondence in the early days of the pandemic in 2020 to prove that the virus had a natural origin in the Wuhan wet market. This concerted disinformation campaign has been given life once again by some virologists who fear a prospective ban on high risk virus research, an exposure of their role in research like genetic engineering and gain of function, and are more concerned about their own funding than on the safety and welfare of humanity.A MISLEADING STUDY: One of these two articles, an 18-page write-up by 18 authors is titled, The Hunan seafood wholesale market in Wuhan was the early epicentre of the Covid-19 pandemic. It starts with the premise that understanding how Covid-19 virus emerged in 2019 is critical to prevent zoonotic outbreaks. Hence the article predetermines that the virus was natural in origin. The article provides the geographical distribution of the early suspected Covid-19 cases around the wet market in Wuhan, based on a flawed and biased sample. Their spatial distribution maps highlight the wet market location and ignore the Wuhan CDC (the agency that monitored the outbreak initially) just 280 metres away, leave alone the WIV 12 kilometres away. The Wuhan CDC had hosted experimental wild animals including bats collected from Hubei and Zhejiang provinces. The writers of the article found many early cases that had no direct links with the market. They found susceptible mammals such as racoon dogs for sale, but were unable to identify an intermediate host. They conceded that there is insufficient evidence to define upstream events, and exact circumstances remain obscure. They still concluded that our analyses indicate that the emergence of SARS-CoV-2 occurred via the live wildlife trade in China, and show that the Huanan market was the epicentre of the COVID-19 pandemic. It is to be noted that the epicentre of an outbreak would be a crowded place near the source of the virus, and not necessarily the source itself.THE OTHER MISLEADING STUDY: The other article, a 15-page study by 29 authors from the same institutions, and titled, Molecular epidemiology of multiple zoonotic origins of SARS-CoV2 examines the strains of the virus found in the early stages of the outbreak in Wuhan. They mention two virus lineages A and B and propose multiple cross species transmissionsof lineage B virus to humans around 18 November 2019 and later of lineage A within a few weeks. It is simple logic that a cross species transmission that did not occur in centuries of existence of wet markets in China is most unlikely to occur multiple times in quick succession. Their claim papers over the well-known fact that gain of function research produces multiple strains. Who should know this better than these virologists? They speculate about racoon dogs and other mammals being the intermediate hosts, but their numerous errors suggest that animals and their samples may have been contaminated by infected humans. Their conclusion also ignores the fact that the only bats in Wuhan existed in the Wuhan labs and not in the wet market.LAY MEDIA AND PUBLIC MISLED: Newspaper and network news journalists and ombudsman have always had a tough time understanding technical jargon and making sense of scientific claims. It is worse when leading experts publish scientific articles with dubious claims. Ideally the results of a scientific study should be explained rationally and should lead to a logical conclusion. It should not be reverse engineered to achieve a predetermined conclusion. Sometimes, as with these two studies the elaborate data and statistical analysis seems authentic but the authors jump to a conclusion that is not justified. An article by Laura Ungar on 27 July 2020 in Associated Press based on these two studies in Science and titled New studies bolster theory coronavirus emerged from the wild quotes Dr Kristian G. Andersen as saying, Have we disproven the lab leak theory? No, we have not, but I think whats really important here is there are possible scenarios and there are plausible scenarios and its really important to understand that possible does not mean equally likely. This article was prominently republished by many leading Indian newspapers with the headline eventually evolving to an emphatic Covid did originate in Wuhan market, say 2 studies. Tragically, this will now be accepted as gospel truth by many in academia, intelligence, political and administrative circles.SUMMARY OF EVENTS LEADING TO COVID-19 ORIGIN: After leaks even from the safest of western virology laboratories and outcry about creation of deadly Chimera viruses by virologists hoping to profit on vaccines for novel human viruses; this risky virus research with technology, equipment and facilities was outsourced to China. Chinese researchers were trained in gain of function and genetic engineering techniques, funded and hand held by well-connected senior US virologists. Western collaboration enabled Chinese researchers to clandestinely or otherwise collect deadly viruses existing in the wild in various parts of the world and steal samples from western laboratories.THE ORIGINAL COVER-UP: My article of 6 June 2021, in The Sunday Guardian, titled, International scientists covered up the lab origin of Covid-19 details the original cover-up. Here is a brief recap of the original cover-up from that article: On 1 Feb 2021, within hours of the researchers from IIT New Delhi submitting their findings online on bioRxiv, alarm bells rang around the world. Dr Kristian G. Andersen of Scripps Research Institute emailed Dr Fauci: Some of the features look engineered, inconsistent with expectations from evolutionary theory. Following this a concerted suppression of findings, including of the New Delhi group was done by vested interests. On 19 February 2020, a group of 27 senior virologists from the US, Australia, Germany, Spain, UK, Netherlands, Italy, Malaysia, Hong Kong including Peter Daszak, president of the EcoHealth Alliance, that was funding WIV, published in Lancet a Statement in support of the scientists, public health professionals, and medical professionals of China combatting COVID-19. In a correspondence published on 17 March 2020 in Nature titled The proximal origin of SARS-CoV-2, Kristian G. Andersen, who on 1 February had emailed Dr Fauci, now turned contrarian and with four other researchers argued that Our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus. On 26 March 2020, Dr Francis Collins supported Dr Andersens analysis on the NIV directors blog: next time you come across something about COVID-19 online that disturbs or puzzles you, I suggest going to FEMAs new Coronavirus Rumor Control web site. It will help to distinguish rumours from facts.The motto of these compromised researchers is: If you cant convince them, confuse them.Dr P.S. Venkatesh Rao is Consultant Endocrine, Breast & Laparoscopic Surgeon, Bengaluru.

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China's apologists again try to cover up Wuhan lab leak of Covid-19 - The Sunday Guardian Live - The Sunday Guardian

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Do you sleep through the night? Your brain rhythmically oscillates between awake and asleep up to 100 times a night – Genetic Literacy Project

Posted: August 5, 2022 at 2:20 am

Sleep is a complex neurological process characterized by shifting brain patterns, fluids flushing in and out of the skull, and a drop in body temperature, all with the apparent aim of restoring the brain as its waking functions are disabled.

In this process, the hormone norepinephrine appears to play a significant role, even though its released at lower levels during sleep compared to when were awake.

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We have learned that noradrenaline causes you to wake up more than 100 times a night, co-first author Celia Kjrby, an assistant professor from the Center for Translational Neuromedicine, said in a statement.

Neurologically, you do wake up, because your brain activity during these very brief moments is the same as when you are awake. But the moment is so brief that the sleeper will not notice, PhD student Mie Andersen, the other co-first author of the study, added.

You could say that the short awakenings reset the brain so that it is ready to store memory when you dive back into sleep, Maiken Nedergaard, a Professor of Glial Cell Biology at the University of Copenhagen, speculated.

Indeed, when the researchers artificially reduced the amplitude of norepinephrines oscillation in mices sleeping brains, either through genetic engineering or pharmaceuticals, they found that the mice performed worse on memory tests compared to unaltered controls.

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CRISPR and Cas Genes Market: The DNA-free Cas Segment Boost Growth in the Global Market – BioSpace

Posted: July 3, 2022 at 2:12 am

Wilmington, Delaware, United States, Transparency Market Research Inc.: CRISPR cas systems are commonly used in microbial engineering that includes immunization of cultures, bacterial strain typing, and self-targeted cell killing. Further, CRISPR and cas genes market system is also applied to control metabolic pathways for an improved biochemical synthesis. This technology is also used for the improvement of crop production. These factors further drive growth in the CRISPR and cas genes market.

CRISPR and cas genes system has been a revolutionary initiative in the biomedical research field. The application of this technology in somatic cell genome editing events has targeted to its application. The technologies are commonly used for the treatment of different genetic disorders. But, the ethical issues while using the system from the CRISPR and cas genes market are somewhere curtailing the growth in the industry. Furthermore, the market is also witnessing a lack of proficient professionals, which restrains its growth opportunities.

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The market forecast on CRISPR and cas genes market was estimated US$ 1,451.6 Mn. Now it is predicted to climb US$ 7,234.5 Mn during forecast period from 2018 to 2026. The market is estimated to reach a compound annual growth rate (CAGR) of 20.1% from 2018 to 2026.

Multiple Applications and Diverse Dominating Factors in CRISPR and Cas Genes Market

The report from market research on CRISPR and cas genes industry has marked its division on the basis of region, end-user, application, and product type. DNA-free cas and vector-based cas are the two types in which the CRISPR and cas genes market is bifurcated on the basis of product type. Between these two types, the vector-based cas section has dominated the market at international levelin 2017. This expression system is helpful for the researchers who are focusing to enrich Cas9-expressing cells and concentrate on the establishment of a stable cell line. The vector-based cas is available with an analytical that is used to support the creation of durable cell lines. These lines are designed with minimal possible background expression.

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The major advantages of the DNA-free cas segment boost growth in the CRISPR and cas genes market. DNA-free cas components are used for the reduction of potential off-targets. They also find application to trace correlations with human illnesses.

Knockout/activation, functional genomics, disease models, and genome engineering are the classification types in the CRISPR and cas genes market on the basis of application in different verticals. Contract research organizations, government and academic research institutes, pharmaceutical and biotechnology companies are some of the key end-use industries in the market. Further, as per the market analysis report on CRISPR and cas genes market, the industry is spread in different regions that include Middle East & Africa, Latin America, Asia Pacific, Europe, and North America.

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The industry players from market have adopted inorganic and organic growth strategies for the expansion of product offerings, capturing market share, increasing consumer base, and strengthening geographical reach. Some of the key players in the CRISPR and Cas genes market include Dharmacon, Synthego, GenScript, OriGene Technologies, Inc., Applied StemCell, Inc., Addgene, and Cellecta, Inc.

Genome Engineering to Dominate CRISPR and Cas genes market

On the basis of application, the genome engineering section has dominated in the CRISPR and cas genes market. The genetic materials can be added, detached, and altered with the help of CRISPR technology at any specific location in the genome. Genomic engineering is related to the synthetic assembly of comprehensive chromosomal DNA, and it has been commonly taken from natural genomic sequences.

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The CRISPR and Cas genes market has been dominated by pharmaceutical and biotechnology companies in terms of end-user. The strategic partnerships and innovations may boost growth in the market.

North America and Europe are the regions that account for the maximum share in the CRISPR and Cas genes market. Rising technological advancements and research activities are driving growth in the market.

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Plants aren’t good at photosynthesis. We can do it better – Big Think

Posted: July 3, 2022 at 2:12 am

Can we improve photosynthesis?

The examples described in this chapter show at least some of the things we need to do as we try simultaneously to feed our population and keep our planet habitable. As science advances, new possibilities become available and we periodically get excited about futuristic ways of limiting the damage of climate change. Successful demonstrations have shown that giant chemical air scrubbers might help to clean carbon dioxide from the air. Inventors promote the idea of growing new foods in bioreactors. Since we humans are tinkerers, it is perhaps inevitable that we will even try to improve photosynthesis itself.

Why would we meddle with photosynthesis? When compared to the best photovoltaic cells, photosynthesis is simply inefficient. The average land plant converts 0.1 to 1 percent of the sunlight striking it into useful chemical energy. Crop plants, if well managed, achieve an overall rate of 1 to 2 percent of effective energy conversion. Even at peak performance, our own microalgae in our sun-filled desert ponds only operate at 6 percent efficiency. That is rather poor performance when compared to the latest six-junction photovoltaic cells with light concentrators that are nearing 50 percent of light to useful electric energy conversion, developed at the U.S. National Renewable Energy Laboratory (NREL). Clearly, theres a lot of potential for improving photosynthesis.

I am one of the scientists who have tried. Back in the mid-1980s at the Massachusetts Institute of Technology, I helped create the first site-directed mutants of something called Photosystem II. After the exhausted excitement of working several-hundred hour weeks and sleeping in the lab, we discovered that it is difficult to improve on four billion years of evolution. The idea, however, was a good one. We were trying to understand how the photosynthetic machinery converts light into chemical energy.

Similarly, scientists have tried to tackle the problem of photorespiration. As discussed in Chapter 2, this is the paradox in which photosynthesizing organisms struggle to deal with the oxygen they produce, which reduces their ability to fix carbon by around 25 percent. There are multiple genetic engineering initiatives to reduce this photorespiration waste and increase the overall productivity of agricultural crops. Some plants, such as corn, have ways of storing carbon produced during the night so that they can enrich the photosynthetic conversion of carbon dioxide into complex chemicals during the day. There are projects currently underway that are seeking to introduce these carbon-concentrating mechanisms into other commercially significant crops. Scientists at the US Agricultural Research Service and the University of Illinois have, for instance, successfully increased photosynthetic efficiency in tobacco leaves by 20 percent. Wild mustard, pumpkin, and green algal and bacterial genes were recombined and promoted, to optimize the photosynthetic metabolism. Now the team is seeking to import this upgraded photosynthetic system into crop plants, such as wheat, rice, or soy. A 20 percent increase in their productivity would mean that we could feed significantly more people without using more land.

Others have attempted to create artificial leaves or artificial photosynthesis. These are important efforts to isolate, focus, and improve the advantages of photosynthesis in more efficient devices. Some create devices that perform the same function of capturing CO2 and turning it into useful chemicals such as syngas (synthetic gas: a fuel-gas mixture), while others are using photovoltaic energydriven membranes to capture CO2 to concentrate it with electrically charged membranes. In recent years, a major step toward artificial, but still biological, photosynthesis has been achieved by isolating chloroplast components in microscopic assemblages and separating them from the rest of the cell to boost their efficiency. The Franco-German team behind this project envisions that their enhanced photosynthetic machinery might be used to synthesize, for example, complex pharmaceutical molecules with the power of light.

All these inventive approaches have advantages and limitations. Often the net environmental impact is uncertain or very costly. In some cases, these improvement efforts simply transfer the efficiency or cost problem elsewhere. Most of these new devices lack long-term sustainability; they also take a lot of time and large amounts of money. The latest photovoltaic cells took more than fifty years to reach their current peak efficiencies, while the average installed base of photovoltaic cells linger between 15 and 20 percent efficiency.

Yet we need to try every advance, assess every potential solution, use every method to engage people and keep them engaged. Growing our world again will require hyperbolic entrepreneurism, new technology, and traditional methods. As we have seen, science is helping us in all sorts of waysupgrading pasturelands through managed grazing, inventing low-energy methods for making ammonia, providing new methods of recycling organic materials. There are nearly 63,000 power plants, hundreds of millions of hearths, and billions of cars, all burning fossil fuels. It requires as many ideas, methods, and approaches to balance their legacy.

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Of course, we need to improve agriculture and photosynthesis to use the agricultural land we have more effectively to grow food for all of us. We must continue to innovate, experiment, and push the limits of what is possible in terms of carbon removal and to increase the efficiency of photosynthesis itself, even if this is difficult. But that misses the opportunity to use photosynthesis in its current state, as it is today. Photosynthesizers grow in every environment: under the ice in Antarctica; stuck to the side of granite buildings; in forests, fields, oceans, and modern urban greenhouses. Even if less efficient, plant life covers a much larger surface area than all other carbon-capturing technologies combined, including both natural processes and artificial onesthe latter taking years to design, build, and commission. Plants have installed themselves already; they capture carbon while repairing, seeding, and multiplying themselves, feeding all ecosystems, and flexibly responding to environmental change, seasonality, and weather. Nobody must come and clear leaves of dust in the same way we need to clear photovoltaic cells to keep them operating. Most importantly, photosynthetic organisms are free to use today, and we have known, for thousands of years, how to propagate them. All societies know how to grow plants in their local environment, instead of waiting for a future technological breakthrough in efficiency.

Instead of schemes to shade the sun, fill the atmosphere with aerosols, or blast us to other planets, we have the planet-transforming potential of plants working for us today. I am an inventor and I am excited by technology, and I also value prosaic projects that enrich us biologically and economicallylike making a bit more dirt and planting a lot more trees. We can transform our planet for the better, with self-sufficientif not the most efficient photosynthetic technology right now.

This article is an adapted excerpt from How Light Makes Life: The Hidden Wonders and World-Saving Powers of Photosynthesis 2021 by Raffael Jovine. Reprinted with permission of The Experiment. Available wherever books are sold. theexperimentpublishing.com

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Plants aren't good at photosynthesis. We can do it better - Big Think

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