Category Archives: Genetic Engineering

What is CRISPR?

CRISPR is a powerful tool for editing genomes, meaning it allows researchers to easily alter DNA sequences and modify gene function. It has many potential applications, including correcting genetic defects, treating and preventing the spread of diseases, and improving the growth and resilience of crops. However, despite its promise, the technology also raises ethical concerns.

In popular usage, "CRISPR" (pronounced "crisper") is shorthand for "CRISPR-Cas9." CRISPRs are specialized stretches of DNA, and the protein Cas9 where Cas stands for "CRISPR-associated" is an enzyme that acts like a pair of molecular scissors, capable of cutting strands of DNA.

CRISPR technology was adapted from the natural defense mechanisms of bacteria and archaea, a domain of relatively simple single-celled microorganisms. These organisms use CRISPR-derived RNA, a molecular cousin to DNA, and various Cas proteins to foil attacks by viruses. To foil attacks, the organisms chop up the DNA of viruses and then stow bits of that DNA in their own genome, to be used as a weapon against the foreign invaders should those viruses attack again.

When the components of CRISPR are transferred into other, more complex, organisms, those components can then manipulate genes, a process called "gene editing." No one really knew what this process looked like until 2017, when a team of researchers led by Mikihiro Shibata of Kanazawa University in Japan and Hiroshi Nishimasu of the University of Tokyo showed, for the very first time, what it looks like when a CRISPR is in action, Live Science previously reported.

Related: Genetics by the numbers: 10 tantalizing tales

CRISPRs: The term "CRISPR" stands for "clusters of regularly interspaced short palindromic repeats" and describes a region of DNA made up of short, repeated sequences with so-called "spacers" sandwiched between each repeat.

When we talk about repeats in the genetic code, we're talking about the ordering of rungs within the spiral ladder of a DNA molecule. Each rung contains two chemical bases bound together: A base called adenine (A) links up to another called thymine (T), and the base guanine (G) pairs with cytosine (C).

In a CRISPR region, these bases appear in the same order several times, and in these repeated segments, they form what's known as "palindromic" sequences, according to the Max Planck Institute. A palindrome, like the word "racecar," reads the same forward as it does backward; similarly, in a palindromic sequence, bases on one side of the DNA ladder match those on the opposing side when you read them in opposite directions.

For example, a super simple palindromic sequence might look like this:

Short palindromic repeats appear throughout CRISPR regions of DNA, with each repeat bookended by "spacers." Bacteria swipe such spacers from viruses that have attacked them, meaning they incorporate a bit of viral DNA into their own genome. These spacers serve as a bank of memories, which enables the bacteria to recognize the viruses if they should ever attack again. You can also think of spacers like "Wanted" posters, providing a snapshot of the bad guys so they can be easily spotted and brought to justice.

Related: Going viral: 6 new findings about viruses

Rodolphe Barrangou and a team of researchers at Danisco, a food ingredients company, first demonstrated this process experimentally. In a 2007 paper published in the journal Science, the researchers used Streptococcus thermophilus bacteria, which are commonly found in yogurt and other dairy cultures, as their model, according to the Joint Genome Institute, part of the U.S. Department of Energy. They observed that after a viral attack, the bacteria incorporated new spacers into their CRISPR regions. Moreover, the DNA sequence of these spacers was identical to parts of the virus genome.

The team also manipulated the spacers by removing them and inserting new viral DNA sequences in their place. In this way, the researchers were able to alter the bacteria's resistance to an attack by a specific virus, confirming CRISPRs' role in regulating bacterial immunity.

CRISPR RNA (crRNA): CRISPR regions of DNA act as a kind of bank of viral memories; but for that stored information to be useful elsewhere in the cell, it must be copied, or "transcribed," into a different genetic molecule called RNA. Unlike DNA sequences, which remain lodged inside the DNA molecule, this CRISPR RNA (crRNA) can roam about the cell and team up with proteins namely the molecular scissors that snip viruses to bits.

RNA also differs from DNA in that it's only one strand, rather than two, meaning it looks like just a half of a ladder. To build an RNA molecule, one part of the CRISPR acts as a template and proteins called polymerases swoop in to construct an RNA molecule that is "complementary" to that template, meaning the two strands' bases would fit together like puzzle pieces. For example, a G in the DNA molecule would get transcribed as a C in the RNA.

Each snippet of CRISPR RNA contains a copy of a repeat and a spacer from a CRISPR region of DNA, according to a 2014 review by Jennifer Doudna and Emmanuelle Charpentier, published in the journal Science. The crRNA interacts with the Cas9 protein and another kind of RNA, called "trans-activating crRNA" or tracrRNA, in order to help bacteria fend off viruses.

Cas9: The Cas9 protein is an enzyme that cuts foreign DNA. The protein binds to crRNA and tracrRNA, which together guide Cas9 to a target site on the virus's DNA strand where the protein will make its cut. The target DNA that the Cas9 will cut through is complementary to a 20-nucleotide stretch of the crRNA, where a "nucleotide" is a building block of DNA that contains one base.

Using two separate regions or "domains" on its structure, Cas9 cuts both strands of the DNA double helix, making what is known as a "double-stranded break," according to the 2014 Science article.

There is a built-in safety mechanism that ensures that Cas9 doesn't just cut just anywhere in a genome. Short DNA sequences known as "protospacer adjacent motifs," or PAMs, serve as tags and sit adjacent to the target DNA sequence. If the Cas9 complex doesn't see a PAM next to its target DNA sequence, it won't cut. This is one possible reason that Cas9 doesn't ever attack the CRISPR region in bacteria, according to a 2014 review published in Nature Biotechnology (opens in new tab).

Genomes encode a series of messages and instructions within their DNA sequences, and genome editing involves changing those sequences, thereby changing the messages they contain. This can be done by inserting a cut or break in the DNA and tricking a cell's natural DNA repair mechanisms into introducing the targeted changes. CRISPR-Cas9 provides a means to do so.

In 2012, two pivotal research papers were published in the journals Science and PNAS, describing how the bacterial CRISPR-Cas9 could be used to chop up any DNA, not just that of viruses. In this way, the natural CRISPR system could be transformed into a simple, programmable genome-editing tool.

To direct Cas9 to snip a specific region of DNA, scientists can simply change the sequence of the crRNA, which binds to a complementary sequence in the target DNA, the studies concluded.In the 2012 Science article, Martin Jinek and his colleagues further simplified the system by fusing crRNA and tracrRNA to create a single "guide RNA." Thus, genome editing requires only two components: a guide RNA and the Cas9 protein.

"Operationally, you design a stretch of 20 base pairs that match a gene that you want to edit," and from there, one can figure out what the complementary crRNA sequence would be, George Church, a professor of genetics at Harvard Medical School, told Live Science. Church emphasized the importance of making sure that the nucleotide sequence is found only in the target gene and nowhere else in the genome.

"Then the RNA plus the protein [Cas9] will cut like a pair of scissors the DNA at that site, and ideally nowhere else," Church explained. Once the DNA is cut, the cell's natural repair mechanisms kick in and work to piece the DNA back together, and at this point, edits can be made to the genome. There are two ways this can happen:

According to the Huntington's Outreach Project at Stanford University, one repair method involves gluing the two cuts back together. This method, known as "non-homologous end joining," tends to introduce errors where nucleotides are accidentally inserted or deleted, resulting in mutations that could disrupt a gene.

In the second method, the break is fixed by filling in the gap with a sequence of nucleotides. In order to do so, the cell uses a short strand of DNA as a template. Scientists can supply the DNA template of their choosing, thereby writing-in any gene they want, or correcting a mutation.

Scientists originally discovered the CRISPRs in bacteria in 1987, but they didn't initially understand the biological significance of the DNA sequences, and they didn't yet call them "CRISPRs," according to Quanta Magazine (opens in new tab). Yoshizumi Ishino and colleagues at Osaka University in Japan first found the characteristic nucleotide repeats and spacers in the gut microbe Escherichia coli, and as the technology for genetic analysis improved in the 1990s, other researchers found CRISPRs in many other microbes.

Francisco Mojica, a scientist at the University of Alicante in Spain, was the first to describe the distinct characteristics of CRISPRs and found the sequences in 20 different microbes, according to a 2016 report (opens in new tab) in the journal Cell. At one point, he dubbed the sequences "short regularly spaced repeats" (SRSRs), but he later suggested that they be called CRISPRs instead. The term CRISPR first appeared in a 2002 report, published in the journal Molecular Microbiology and authored by Ruud Jansen of Utrecht University, with whom Mojica had been in correspondence.

In the following years, scientists also discovered Cas genes and the function of Cas enzymes, and they figured out that the spacers in CRISPRs came from invasive viruses, Quanta reported.

Among these pioneering researchers was Jennifer Doudna, a professor of biochemistry, biophysics and structural biology at the University of California, Berkeley, who went on to share the 2020 Nobel Prize in chemistry with Emmanuelle Charpentier, director of the Max Planck Unit for the Science of Pathogens. The two scientists are credited with adapting the bacterial CRISPR/Cas system into a handy gene-editing tool, Live Science previously reported.

Related: Nobel Prize in Chemistry: 1901-Present

Charpentier initially discovered tracrRNA while studying the bacteria Streptococcus pyogenes, which causes a range of diseases from tonsillitis to sepsis. Having uncovered tracrRNA as a previously unknown component of the CRISPR/Cas system, Charpentier began collaborating with Doudna to recreate that system in a test tube. In 2012, the team published their seminal work (opens in new tab) in the journal Science, announcing that they'd successfully simplified the molecular scissors into a gene-editing tool.

Some thought that biochemist Feng Zhang of the Broad Institute might also earn the Nobel for his own, separate work with the CRISPR system, Science Magazine reported. Zhang demonstrated that the CRISPR system works in mammalian cells, and based on this work, the Broad Institute earned the first patent for the use of CRISPR gene-editing technology in eukaryotes, or complex cells with nuclei to hold their DNA.

In 2013, researchers in the labs of Church and Zhang published the first reports describing the use of CRISPR-Cas9 to edit human cells in an experimental setting. Studies conducted in lab dish and animal models of human disease have demonstrated that the technology can effectively correct genetic defects. Examples of such diseases include cystic fibrosis, cataracts and Fanconi anemia, according to a 2016 review article (opens in new tab) published in the journal Nature Biotechnology. These studies have paved the way for therapeutic applications in humans.

In the realm of medicine, CRISPR has been tested in early-stage clinical trials as cancer therapy and as a treatment for an inherited disorder that causes blindness. It's also been investigated as a strategy for preventing the spread of Lyme disease and malaria from viral vectors to people, and it's also been studied in animal models of HIV as a way to rid infected cells of the virus, Live Science previously reported. One research team in China attempted to treat a human patient's HIV using CRISPR, and while the treatment wasn't successful in curing the infection, the gene therapy also didn't cause any harmful effects, Live Science reported.

"I think the public perception of CRISPR is very focused on the idea of using gene editing clinically to cure disease," said Neville Sanjana of the New York Genome Center and an assistant professor of biology, neuroscience and physiology at New York University. "This is no doubt an exciting possibility, but this is only one small piece."

Related: 10 amazing things scientists just did with CRISPR

CRISPR technology has also been applied in the food and agricultural industries to engineer probiotic cultures and to vaccinate industrial cultures (yogurt, for example) against viruses. It is also being used in crops to improve yield, drought tolerance and nutritional properties.

One other potential application is to create gene drives, a genetic engineering technique that increases the chances of a particular trait passing on from parent to offspring; this kind of genetic engineering derives from a natural phenomenon, where specific versions of genes are more likely to be inherited. Eventually, over the course of generations, the trait spreads through entire populations, according to the Wyss Institute. Gene drives could be used for various applications, such as eradicating invasive species or reversing pesticide and herbicide resistance in crops, according to a 2014 report published in the journal Science.

During the COVID-19 pandemic, the CRISPR-Cas9 system has been used to develop various diagnostic tests for the viral infection, BBC News reported.

In addition, CRISPR has recently been used in the following ways:

However, despite its wide range of uses, the tool is not without its drawbacks.

"I think the biggest limitation of CRISPR is it is not a hundred percent efficient," Church told Live Science. That means, in a given experiment, CRISPR may successfully edit only a percentage of the targeted DNA. According to the 2014 Science article by Doudna and Charpentier, in a study conducted in rice, gene editing occurred in nearly 50% of the cells that received the Cas9-RNA complex. Meanwhile, other analyses have shown that depending on the target, editing efficiencies can reach as high as 80% or more.

The technology can also create "off-target effects" when DNA is cut at sites other than the intended target. This can lead to the introduction of unintended mutations. Furthermore, Church noted, even when the system cuts on target, there is a chance of not getting a precise edit. He called this "genome vandalism."

The many potential applications of CRISPR technology raise questions about the ethical merits and consequences of tampering with genomes. And in particular, a slew of ethical debates flared up in 2018 when He Jiankui, formerly a biophysicist at the Southern University of Science and Technology in Shenzhen, announced that his team had edited DNA in human embryos and thus created the world's first gene-edited babies.

He was subsequently sentenced to three years in prison and fined 3 million yuan ($560,000) for practicing medicine without a license, violating Chinese regulations on human-assisted reproductive technology and fabricating ethical review documents, Live Science previously reported. But even after his sentencing, He's experiments raised questions about how the use of CRISPR should be regulated going forward, especially given that the technology is still fairly new.

Related: Here's what we know about CRISPR safety

Illegal experimentation in human embryos represents an extreme misuse of CRISPR, of course, but even seemingly ethical uses of the technology could carry risks, scientists say.

In general, making genetic modifications to human embryos and reproductive cells such as sperm and eggs is known as germline editing. Since changes to these cells can be passed on to subsequent generations, using CRISPR technology to make germline edits has raised a number of ethical concerns.

Variable efficacy, off-target effects and imprecise edits all pose safety risks. In addition, there is much that is still unknown to the scientific community. In a 2015 article published in Science, David Baltimore and a group of scientists, ethicists and legal experts note that germline editing raises the possibility of unintended consequences for future generations "because there are limits to our knowledge of human genetics, gene-environment interactions, and the pathways of disease (including the interplay between one disease and other conditions or diseases in the same patient)."

In the 2014 Science article, Oye and colleagues point to the potential ecological impact of using gene drives. An introduced trait could spread beyond the target population to other organisms through crossbreeding. Gene drives could also reduce the genetic diversity of the target population, potentially hampering its ability to survive.

Other ethical concerns are more nuanced. Should we make changes that could fundamentally affect future generations without having their consent? What if the use of germline editing veers from being a therapeutic tool to an enhancement tool for various human characteristics?

To address these concerns, the National Academies of Sciences, Engineering and Medicine put together a comprehensive report with guidelines and recommendations for genome editing.

Although the National Academies urge caution in pursuing germline editing, they emphasize "caution does not mean prohibition." They recommend that germline editing be done only on genes that lead to serious diseases and only when there are no other reasonable treatment alternatives. Among other criteria, they stress the need to collect data on the health risks and benefits and to maintain continuous oversight during clinical trials. They also recommend that, after a trial concludes, trial organizers should follow up with the participants' families for multiple generations to see what changes persist in the genome over time.

This article includes additional reporting by Alina Bradford, Live Science contributor.

Originally published on Live Science.

Continued here:
What is CRISPR? | Live Science

Against the backdrop of the cost-of-living crisis it is argued that the UK could bolster food security, combat climate change and lower food prices by relaxing the rules on and around genetic engineering. By designing more resistant crops which are less reliant on fertiliser and are more nutritious, progress could be made. On the other hand, this may be a short-sighted approach to deregulation and taking the risk could result in disastrous consequences.

The Genetic Technology (Precision Breeding) Bill 2022

The arguments are surfacing as The Genetic Technology (Precision Breeding) Bill (GT (PB) Bill) which is currently in the House of Commons at the report stage (allowing the House to consider further amendments) heading for its 3rd reading. Much of the debate centres around the understanding of the technology.

Genetically Modified Organisms (GMOs) are organisms in which the genetic material (DNA or RNA) has been altered in a way that does not occur naturally, and the modification can be replicated and/or transferred to other cells or organisms. This typically involves the removal of DNA, manipulation outside the cell and reinsertion into the same or other organism. Gene editing (GE) is arguably different as rather than inserting new DNA it edits the organisms own DNA - which could happen over time, but this essentially speeds up the natural process. Both plants and animals can be genetically manipulated.

Regulation (EC) No 1829/2003 provides the general framework for regulating genetically modified (GM) food in the EU with a centralised procedure for applications to place GM food on the EU market. It focusses on the traceability and labelling of GMO and the traceability of food and feed products to ensure a high level of protection of human life and health. GM foods can only be placed on the market after scientific risk assessment of the risks to human health and the environment.

The EU implemented these regulations back in 2001 which heavily restricted the use of GMOs and it has maintained that conservative position since. To continue not to allow GMOs is at odds with other countries, such as Australia, Japan and the US. As the technology developed several member states (including the UK) felt that a more relaxed approach to genetic editing would be beneficial. However, in 2018 the European Court of Justice in, Confederation Paysanne v Premier Minister (C-528/16) decided that there was no real distinction with gene editing (also described as Precision breeding) and they were to be treated as GMOs within the meaning of the GMO Release Directive 2001.

Nevertheless, in the UK in 2019 the then prime minister famously declared that he would liberate the U.K.s extraordinary bio science sector from anti-genetic modification rules. Consequently, since leaving the EU the UK has been working on moving away from the EUs stricter definition of a GMO as evidenced by the GT (PB) Bill.

The Bill defines precision bred to be, if any, or every feature of its genome results from the application of modern biotechnology and every feature of its genome could have resulted from either traditional processes or natural transformation.[1]

It is argued that this removes unnecessary barriers to innovation inherited from the EU to allow the development and marketing of precision bred plants and animals, which will drive economic growth and position the UK as a leading country in which to invest in agri-food research and innovation.

The main elements of the Genetic Technology (Precision Breeding) Bill are:

Creating a new, simpler regulatory regime for precision bred plants and animals that have genetic changes that could have arisen through traditional breeding or natural processes. No changes are proposed to the regulation of animals until animal welfare is safeguarded.

Introducing two notification systems for research and marketing purposes where breeders and researchers will need to notify Department for Environment, food and Rural Affairs (Defra) of precision bred organisms. The information collected on precision bred organisms will be published on a public register.

Establishing a new science-based authorisation process for food and feed products developed using precision bred organisms.

This is the result of an All-Party Parliamentary Group which called for amendments to be made in 2020 to the, at the time, forthcoming Agriculture Bill 2019-21 (now the Agriculture Act 2020) to allow precision breeding in the UK.

The amendments would require changes to the UK Environmental Protection Act 1990, including changing the use of the EU definition of a GMO which would allow UK scientists, farmers and both plant and animal breeders access to gene editing technologies that other countries outside the EU have.

The focus in the UK is to allow traditional breeding methods to alleviate some of the effects such as extreme weather, food shortages, the cost-of-living crisis and to encourage pest-resistance.

The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022

On 11th April 2022, the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 implemented an alignment of GE with the regulation of plants using traditional breeding methods. The Regulations removed the need to submit a risk assessment and seek consent from the Secretary of State before releasing certain GE plants for non-marketing purposes. They apply to England only.

This will allow for the release and marketing of gene edited products under certain circumstances that has so far been prohibited by the EU. It will allow UK scientists to develop plant varieties and animals with beneficial traits that could also occur through traditional breeding and natural processes, while providing safeguards in both marketing and authorisations via regulation.

Taking a Risk?

Another consequence of leaving the EU is that the Food Standards authority (FSA) is now responsible for authorising Novel foods applications in the UK. The FSA points to this need for authorisation as a further check and balance on any risks that may arise from a divergence from EU regulation.

Although it is argued that the Bill may have been drafted a little hastily, any food developed using new technology is subject to the scientific scrutiny of a Novel foods application. If there is a risk of unintended consequences from GE (it is argued that there is a risk of unidentified and untested mutations resulting from gene editing) the role of regulatory authorities such as DEFRA and the FSA is to ensure that no unintended product gains approval.

The debate is becoming increasingly focussed as the cost-of-living crises deepens.

Co-Authored by Laura Hipwell, Trainee Solicitor at CMS.

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To modify or not to modify? Genetic Modification and Gene Editing - A divergence by the UK - Lexology

THE double helix structure of DNA was discovered in 1953, but at the time the structure of genes themselves remained unknown. But the term gene had already been in use for decades as a convenient term for the mysterious basic unit of heredity.

Writing in 1911, the Danish botanist Wilhelm Johannsen referred to the term as nothing but a very applicable little word, easily combined with others. Once it was understood that genes were made of DNA, new questions opened up.

In the 1950s and onwards, the only organisms that could really be investigated in detail were microorganisms. As a result, almost all early molecular biology was done on bacteria and their viruses.

A bacterial chromosome contains many genes. Escherichia coli, the most-studied bacterial species, has a circular chromosome that has thousands of genes, arranged one after the other.

Could it be possible to make a molecule of DNA that consisted of only one of these genes in other words, to isolate a gene from the chromosome?

One of the most-studied groups of genes in this early period was the lac operon. An operon is a small set of neighbouring genes under the influence of a single molecular switch.

The lac operon contains genes that encode proteins that allow for lactose to be used as an energy source, allowing the production of these proteins to be turned on only when another sugar is not present. French scientists Francois Jacob and Jacques Monod won a Nobel Prize in 1965 for uncovering how this system of genetic regulation worked.

In 1969, scientists at Harvard managed to make a DNA molecule that contained only the lac operon and no other genes. To do this, they used two viruses of bacteria which, together with other genes, carried the lac operon in opposite orientations.

These could then be joined together to create a double helix molecule with only the lac operon on it. This meant they had isolated a small set of genes which could be entirely switched on or off with a single molecular switch, which allowed amazing possibilities for future experiments.

The team felt the findings were so important that they held a press conference to announce them. But unusually, this was not framed as a positive announcement: Jon Beckwith, the leader of the research, described the possible implications of their own work as frightening.

In a New York Times article on this brilliant isolation of a gene, appearing underneath a piece on dialogue between East and West Germany, scientist Jim Shapiro was quoted as saying that the work may have bad consequences over which we have no control possibilities such as genetic warfare.

A graduate student involved wrote afterwards that the only reason the news was released to the press was to emphasise its [the sciences] negative aspects. The atmosphere Beckwith promoted in his group was unusual and came from his political convictions.

In the same year that the lac operon paper was published, he accepted the Eli Lilly award, a prominent award for microbiologists funded by a pharmaceutical company.

In his acceptance speech, he stated science in the hands of the people who rule this country and who run our industries is being used to exploit and oppress people all over the world.

He then donated all of the prize money to the Black Panther movement: one half of the prize money to the Boston Panther Free Health Movement and the other half to the Defence Fund for the Panther 21 in New York.

Beckwith knew that, unlike genes, science could never be isolated from its social and political context. The field that developed out of these discoveries already had a name by 1969: genetic engineering.

These days genetic engineering has become a huge field that involves applications, not just experiments in the lab. However, many of the crucial tools continue to be developed from microorganisms.

Viruses and bacteria deal with genes entering and leaving their genomes all the time. As a result, their evolution has produced many exquisite solutions for gene manipulation: recombinant DNA and CRISPR being two famous examples.

Gene therapy based on these tricks to deliver new genetic material into the human genome is already being used in clinical medicine.

With growing databases of known genomes, scientists can now search systematically for evolutionary solutions that might be adapted further for human genetic engineering.

In a Nature Biotechnology paper out this week, scientists from Stanford and Berkeley computationally searched through nearly 200,000 genomes to predict new enzymes belonging to a type known as large serine recombinases.

These enzymes can recombineDNA, meaning they integrate new DNA into specific sites in a genome an ideal tool for genetic engineering.

They then experimentally tested these recombinases and their integration sites, they managed to increase the number of known enzymes and corresponding sites by over 100 times.

The scientists write in an understated way that their work has potential clinical and research utility. The new catalogue of recombinases does offer huge potential for gene therapy, replacing missing or mutated genes in very sick patients.

But genetic engineering also has risks. As the New York Times noted in 1969, it is nice to believe that the powers of science will be used only for benefit but every days newspaper provides evidence suggesting that the contrary may be true. The political convictions of the lead scientist in 1969 made a huge difference to the understanding of the research in public.

The lead scientist, Patrick Hsu, is a founder of the Arc Institute, a non-profit but independent research organisation co-founded with scientist Silvana Konermann and the entrepreneur Patrick Collison, the CEO of payments company Stripe.

The aim of Arc is a new model of science funding to get important discoveries into the public domain as quickly as possible. The announcements from the Arc Institute are relentlessly positive.

But the nuanced message of Beckwiths press conference during the beginnings of the field should stay with us as a warning: what happens after a scientific discovery is important. Responsible science means articulating risks as well as benefits.

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DNA and the impossibility of research in isolation - Morning Star Online

The Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO)* has achieved the final step of the re-examination process of Article 13 of the Convention on Human Rights and Biomedicine (Oviedo Convention) with the adoption of the clarifications on the scope of the provisions with regard to research and the purposes limitation provided for any intervention on the human genome.

In June 2021, as a first conclusion, the Committee had agreed that taking into account the technical and scientific aspects of theses developments, as well as the ethical issues they raise, it considered that the conditions were not met for a modification of the provisions of Article 13. However, it agreed on the need to provide clarifications, in particular on the terms preventive, diagnostic and therapeutic and to avoid misinterpretation of the applicability of this provision to research.

These clarifications were adopted by the CDBIO at its 1st plenary meeting (31 May 3 June 2022) and presented to the Committee of Ministers on 27 September 2022.

In this video, Anne Forus, Chair, and Pete Mills, member, of the CDBIO Drafting group on genome editing present the context, the content and the importance of these clarifications.

Context

This re-examination process of Article 13 was undertaken within the framework of the Strategic Action Plan on Human Rights and Technologies (2020 2025), as part of the actions planned under its Governance pilar and the specific objective of embedding human rights in the development of technologies which have an application in the field of biomedicine.

As underlined by the DH-BIO in November 2018, ethics and human rights must guide any use of genome editing technologies in human beings in accordance with the Convention on Human Rights and Biomedicine (the Oviedo Convention, 1997) - the only international legally binding instrument addressing human rights in the biomedical field which provides a unique reference framework to that end. The Oviedo Convention represents the outcome of an in-depth discussion at European level, on developments in the biomedical field, including in the field of genetics.

Article 13 of the Convention addresses these concerns about genetic enhancement or germline genetic engineering by limiting the purposes of any intervention on the human genome, including in the field of research, to prevention, diagnosis or therapy. Furthermore, it prohibits any intervention with the aim of introducing a modification in the genome of any descendants. This Article was guided by the acknowledgement of the positive perspectives of genetic modification with the development of knowledge of the human genome; but also by the greater possibility to intervene on and control genetic characteristics of human beings, raising concern about possible misuse and abuses.

More information:

* In January 2022, the CDBIO took over the responsibility of the Committee on Bioethics (DH-BIO) as the committee responsible for the conduct of the intergovernmental work on human rights in the fields of biomedicine and health. The CDBIO is also advising and providing expertise to the Committee of Ministers of the Council of Europe on all questions within its field of competence.

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Genome editing technologies: final conclusions of the re-examination of Article 13 of the Oviedo Convention - Council of Europe

San Diego, CAThe annual Cell & Gene Meeting on the Mesa in San Diego kicked off this week with a packed schedule of sessions and some 40 company presentations that speak to the significant progress in these burgeoning therapeutic fields.

Organized by the Alliance for Regenerative Medicine, the program has attracted more than 1,700 attendees, 20% of whom are C-level executives. Although opting for a hybrid format, the enthusiastic number of live attendees signaled the thrill and benefits of live conferences and networking.

Commercialization is around the bend

The opening plenary session covered current trends and challenges surrounding gene therapy commercialization. Moderated by Dave Lennon, PhD, CEO of Satellite Bio, the panel discussed critical topics related to bringing these potentially life-changing treatments to market: pricing, the hurdles of early access, accelerated approval requirements, novel go-to-market challenges, and considerations of global equity.

Arguably the key rate-limiting step for commercialization is regulatory approval. Debbie Drane, senior vice president (SVP) of Global Commercial Development and Therapeutic Area (TA) Strategy at CSL Behring, discussed how regulators do not understand all diseases equally. Some of the targeted rare diseases do not have a clinical or regulatory precedent. Regardless of a regulatory bodys familiarity with a disease, Drane thinks making durability claims with gene editing can be tricky. For example, CSL Behrings EtranaDez, potentially the first gene therapy for patients living with hemophilia B, accepted by the FDA for priority review last May, will have to be compared to existing chronic treatments.

Regarding access to gene therapy before approval, Matthew Klein, MD, chief operating officer (COO) at PTC Therapeutics, said, Were in a special situation with one-time administered gene therapies. Thats different than when you have a repeat-administered small molecule, for example, where you can leverage compassionate use programs and expanded access programs to accelerate commercialization on the other side of approval. Obviously, with a one-time administrative therapy, you must think carefully about how that plays out.

Klein laid out PTCs different approaches, including early access programs to leverage treating patients before finalizing pricing and negotiation. Were looking to European countries like France with early access programs that allow us to provide commercial drugs prior to finalizing reimbursement discussions, he said.

Upon drug approval, one of the first things that happen is that patients and families worldwide start to reach out. According to Leslie Meltzer, PhD, chief medical officer (CMO) at Orchard Therapeutics, this is a relationship that needs to be cultivated from the earliest stages of development.

Meltzer said companies need to consider what questions the patient communities might have about the safety and efficacy of therapy and how to motivate participation in a corresponding clinical trial. Meltzer advocates for early and frequent patient engagement with a unified voice on the value of a gene therapy product. This can be transformative in reaching communities and setting expectations about timelines and whats involved with therapy.

The high price of one-shot cures

On pricing, Thomas Klima, Chief Commercial and Operating Officer of bluebird bio, discussed the pricing of the cell-based gene therapy product Zynteglo, approved by the FDA in August to treat beta-thalassemia, which will cost $2.8 million per patient. Klima highlighted that people with the most severe form of beta-thalassemia live their lives tethered to the healthcare system. They require regular transfusions and spend an average of 9.8 hours every three to four weeks in a hospital to receive the blood transfusions necessary for survival. Klima claimed that lifetime treatment for transfusion-dependent thalassemia costs more than $6 millionwhich is in line with the projection of $5.4 million from a recent study by Vertexand argued for the value of bluebirds treatment for $2.8 million.

For how commercialization models can expand and evolve, Christine Fox, president of Novartis Gene Therapies, said that part of the equation is bringing these treatments to countries around the world. At the heart of this problem is bringing patient advocacy and medical advisory to countries greatly affected by the clinical indication.

Overall, there was optimism that there would be an upswing in approved gene therapy products, as evidenced by a growing number of clinical trials using CRISPR gene editing. The first-ever approval of a CRISPR gene-editing therapy could be less than a year away. At the same time, base editing has already entered the clinic, and the first in vivo CRISPR approaches are progressing in clinical trials. This progress reflects how much has been learned in assembling the necessary pieces to get these treatments to commercialization, from development and manufacturing to the clinical and regulatory side of the equation.

More than one way to skin a [gene editing] cat

Another interesting session at the Cell & Gene Meeting on the Mesa offered forecasts of near- and longer-term future breakthroughs in clinical genome editing, featuring the CEOs of LogicBio, Homology Medicines, and Arbor Biotechnology as well as the CSO of Editas Medicine.

Devyn Smith, PhD, CEO at Arbor Biotechnologies, said investors understood the promise of genome editing, noting that the valuations of key public companies have held up remarkably well considering the market turmoil over the past two years. [It] is incumbent on all of us in this space to continue executing and hopefully generating positive clinical data so that momentum continues, Smith said.

Mark Shearman, PhD, CSO at Editas Medicine, agreed. With any new technology, the [focus is] on clinical data and proving that its safe and efficacious. Typically, [investors] also want to see a projection of where the programs going and a timeline over which youll be able to submit an application. Theyre also interested in whether you are in control of the technology and have all the infrastructures to monitor the technology to be confident that you can advance it. Lastly, if you have examples where a regulatory authority has reviewed your process and analytics, confidence boosts when approved or accepted.

Tim Farries, PhD, Principal Consultant and Senior Director with the consultancy Biopharma Excellence, also questioned the benefit of launching gene editing programs on rare diseases with small populations to show the relative ease and benefits before expanding to broader indications and populations. But for the most part, genome editing involves modifying DNA at one specific site. Thats why you see gene editing therapies in monogenic disorders right nowbecause you have to know exactly what part of the genome is contributing at a big effect size to the disease that youre trying to treat, said Albert Seymour, PhD, President and CEO at Homology Medicines. Thats a great place to start as we understand a little bit more about larger monogenic indications.

During a discussion on choosing between developing editing tools or understanding biological targets, all panelists hedged towards editing technology. Fred Chereau, president and CEO of LogicBio, favored starting with the editing technology because its where the safety concerns can emerge. Understanding an editing technologys efficiency and precision helps inform product development.

That said, each disease will require a different approach. According to Smith, certain indications will require a cut-and-kill approach to knock out or down a gene, changing an individual base or a series of bases, or impacting regulatory regions. The reality is there are going to be a lot of different ways weve got to skin this cat, and its not going to be one-size-fits-all, said Smith.

Another question addressed what payers would like to see gene editing show over the next three to five years. Shearman answered, For the rare disease area, this should get worked out pretty quickly because, ultimately, [it] wont be an issue of money based on the number of patients. I think the transition to treating large patient populations is going be an interesting one.

Smith said that someone could be wildly successful and completely upend the payers way of doing things. Its an opportunity for new upstarts to come in and figure out new different approaches to innovate, he said. On trying to fit the current approach to reimbursement into the one-and-done therapies, Smith added, its not even a square peg-round holetheyre in different planets. Something has got to give somewhere. This will require different thinking because applying existing models will limit access to patients.

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Approval, Commercialization Highlighted at Cell & Gene Meeting on the Mesa - Genetic Engineering & Biotechnology News

Photo: Galpagos finch, by Mike's Birds from Riverside, CA, US, CC BY-SA 2.0 , via Wikimedia Commons.

Editors note:We are a delighted to present a new series by biologist Jonathan Wells asking, Is Darwinism a Theory in Crisis? This is the third post in the series, which is adapted from the recent book,The Comprehensive Guide to Science and Faith.Find the full series here.

A scientific revolution is fueled in part by growing dissatisfaction among adherents of the old paradigm. This leads to new versions of the theoretical underpinnings of the paradigm. In his 1962 bookThe Structure of Scientific Revolutions, philosopher of science Thomas Kuhn wrote:

The proliferation of competing articulations, the willingness to try anything, the expression of explicit discontent, the recourse to philosophy and to debate over fundamentals, all these are symptoms of a transition from normal to extraordinary research.1

A growing number of biologists now acknowledge that there are serious problems with modern evolutionary theory. In 2007, biologist and philosopherMassimoPigliucci published a paper asking whether we need an extended evolutionary synthesis that goes beyond neo-Darwinism.2The following year, Pigliucci and 15 other biologists (none of them intelligent design advocates) gathered at the Konrad Lorenz Institute for Evolution and Cognition Research just north of Vienna to discuss the question. Science journalist Suzan Mazur called this group the Altenberg 16.3In 2010, the group published a collection of their essays. The authors challenged the Darwinian idea that organisms could evolve solely by the gradual accumulation of small variations preserved by natural selection, and the neo-Darwinian idea that DNA is the sole agent of variation and unit of inheritance.4

In 2011, biologist James Shapiro (who was not one of Altenberg 16 and is not an intelligent design advocate) published a book titledEvolution: A View from the 21st Century. Shapiro expounded on a concept he callednatural genetic engineeringand provided evidence that cells can reorganize their genomes in purposeful ways. According to Shapiro, many scientists reacted to the phrase natural genetic engineering in the same way they react to intelligent design because it seems to violate the principles of naturalism that exclude any role for a guiding intelligence outside of nature. But Shapiro argued that

the concept of cell-guided natural genetic engineering is well within the boundaries of twenty-first century biological science. Despite widespread philosophical prejudices, cells are now reasonably seen to operate teleologically: Their goals are survival, growth, and reproduction.5

In 2015,Naturepublished an exchange of views between scientists who believed that evolutionary theory needs a rethink and scientists who believed it is fine as it is. Those who believed that the theory needs rethinking suggested that those defending it might be haunted by the specter of intelligent design and thus want to show a united front to those hostile to science. Nevertheless, the former concluded that recent findings in several fields require a conceptual change in evolutionary biology.6These same scientists also published an article inProceedings of the Royal Society of London,in which they proposed an alternative conceptual framework, an extended evolutionary synthesis that retains the fundamentals of evolutionary theory but differs in its emphasis on the role of constructive processes in development and evolution.7

In 2016, an international group of biologists organized a public meeting to discuss an extended evolutionary synthesis at the Royal Society in London. Biologist Gerd Mller opened the meeting by pointing out that current evolutionary theory fails to explain (among other things) the origin of new anatomical structures (that is, macroevolution). Most of the other speakers agreed that the current theory is inadequate, though two speakers defended it. None of the speakers considered intelligent design an option. One speaker even caricatured intelligent design as God did it, and at one point another participant blurted out, NotGod were excluding God.8

The advocates of an extended evolutionary synthesis proposed various mechanisms that they argued were ignored or downplayed in current theory, but none of the proposed mechanisms moved beyond microevolution (minor changes within existing species). By the end of the meeting, it was clear that none of the speakers had met the challenge posed by Mller on the first day.9

A 2018 article inEvolutionary Biologyreviewed some of the still-competing articulations of evolutionary theory. The article concluded by wondering whether the continuing conceptual rifts and explanatory tensions will be overcome.10As long as they continue, however, they suggest that a scientific revolution is in progress.

Next,Theory in Crisis? Circling the Wagons.

More:
Dissatisfaction and New Articulations - Discovery Institute

FoodPhotography #climate crisis#farming#flat lay#plants#Uli Westphal#vegetables

Lycopersicum III (2013). All images Uli Westphal, shared with permission

Earlier this year, Russias war in Ukraine obstructed the global food supply in a way that exposed just how precarious the entire system is. The conflict confined25 million tons of corn and wheatto the country, making such a crucial stock inaccessible and compounding the effects of an already urgent crisis.

Combined with disruptions from the COVID-19 pandemic and the continual issues of the climate crisis, the war helped propel global food insecurity to levels unseen in decades. Itsestimated thatapproximately 800 million people around the world dont have enough to eat due to skyrocketing prices caused by increased demand for a reduced supply. These problems are predicted to decimate local economies and prompt widespread unrestin the coming years.

Part of combating such an emergency involves understanding the core of modern production and how growing practices have evolved over time. Back in 2010,artistUli Westphaltook an interest in the ways farming and cultivation were affecting the availability of certain plants after a visit to VERN e.V. The German nonprofit cares for thousands of specimens, makes obscure or rare varieties available to the public, and is also aregional network of gardeners, farmers, and local garden sites. They have a large garden plot in a tiny village two hours north of Berlin, where they grow a kaleidoscope of rare and forgotten crop varieties, he shares. I walked into a greenhouse full of tomato plants bearing fruits that I had never seen in my life.

Cucurbita I (2014)

This encounter prompted whats become a years-long project of documenting the planets incredible agricultural diversity. Encompassing both the wild and the domestic, Westphals ongoing and endlessCultivar Seriesilluminates a vast array of specimens through striking flat-lay photos. Fruits, vegetables, legumes, and other produce arranged by color capture the breadth of the worlds crops, comparing their shapes, sizes, and molecular makeuphigher levels of chlorophyll promote the verdant pigments of leafy greens, for example, while carotenoids are responsible for bright orange carrots.

FromAmsterdam and Potsdam, Germany, to Mexico City and Tucson, the sources of Westphals subject matter are broad, with some fare coming fully grown from farmers and others as seeds to be cultivated.Cucumis sativus I features fifty cucumber varieties the photographer grew in a greenhouse once connected to his Berlin-based studiofrom seeds gifted bya Dutch organization, for example, while the pumpkins and peppers in two of his other works were a collaboration withPeaceful Belly Farm in Boise, Idaho.

Zea Mays II (2022)

Whether depicting potatoes or pears, the imagesoffer a rare glimpse of species that often arent available in the grocery store or markets. Since the industrialization of agriculture, our focus has shifted to only a few modern, high-yielding, robust, good looking, uniform, and predictable varieties. This change has led to the displacement of traditional crop varieties, Westphal writes, noting that when a plant isnt actively cultivated, it often falls under threat of extinction, and such strains tend to be protected by conservation organizations like the seed banks hes collaborated with in the past. A majority of all varieties developed by humans have already become extinct during the last 50 years. With them, we not only lose genetic diversity but also a living cultural and culinary heritage.

The photos also elicit questions about contemporary domestication practices that are of increasing concern as biodiversity dwindles. Westphal tells Colossal:

Synthetic biology is evolving at a rapid speed, out-pacing public awareness, debate, and regulation and is altering life in ways that are unprecedented.My main concerns about synthetic biology (and genetic engineering) are the havoc that the inevitable release of significantly altered organisms into ecosystems can cause and the increasing consolidation of corporate control over what we grow and eat.

Three photos fromThe Cultivar Series are on view as part of the group exhibitionFood in New Yorkthrough September 30, 2023, at the Museum of the City of New York, andWestphal is currently working to document the worlds edible plants, of which hes culled a shortlist of 3,000 species.Prints of his flat lays are available on his site, along with similar collections centered on fruits and other consumables, and you can follow his practice on Instagram. (via Present & Correct)

Cucumis sativus I (2014)

Pyrus I (2018)

Capsicum I (2016)

Phaseolus vulgaris I (2013)

Brassica oleacea I (2018)

Solanum tuberosum II (2020)

Do stories and artists like this matter to you? Become a Colossal Member today and support independent arts publishing for as little as $5 per month. You'll connect with a community of like-minded readers who are passionate about contemporary art, read articles and newsletters ad-free, sustain our interview series, get discounts and early access to our limited-edition print releases, and much more. Join now!

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In 'The Cultivar Series,' Uli Westphal Gets to the Root of Crop Diversity and Agricultural Modification - Colossal

A research team led by a University of Massachusetts Amherst scientist has made a significant genetic discovery that sheds light on the use of the drug caspofungin to treat a deadly fungal infection, Aspergillus fumigatus, which kills some 100,000 severely immunocompromised people each year.

Typically, healthy people inhale about 50 to 100 spores of A. fumigatus every day when outdoors. Our body does a great job of identifying them and destroying them, says UMass Amherst associate professor of food science John Gibbons, whose microbial genomics lab studies the fungus.

But in people with compromised immune systems from cancer treatment, organ transplants, HIV, COVID-19 and other conditions, A. fumigatus can cause a really nasty infection, invasive pulmonary aspergillosis, with a 50% mortality rate, Gibbons says. And theres a limited way to treat these infections.

To complicate matters, when given in high concentrations as a treatment for an A. fumigatus infection, the anti-fungal drug sometimes creates a caspofungin paradoxical effect [CPE], which increases the fungal growth rather than eradicating it.

In research published in the journal Microbiology Spectrum, senior author Gibbons, Shu Zhao, a former graduate student in the Gibbons lab, and colleagues describe a first important step in the effort to understand when and why treatment with caspofungin could be more harmful than beneficial. The team, including scientists from Vanderbilt University, the University of Tennessee Science Health Center and the University of So Paolo in Brazil, completed the first genomic and molecular identification of two genes that contribute to the paradoxical effect in A. fumigatus.

This is one of the first studies to apply genome-wide association (GWA) analysis to identify genes involved in an Aspergillus fumigatus phenotype, the paper states.

The team sequenced the genome of 67 clinical samples, about half of which had CPE, spotting genetic differences between the groups and then using GWA, a statistical method, to determine how these genetic variants are associated with growth patterns at high concentrations of caspofungin. We identified a few candidate genes that we thought might contribute to this paradoxical effect, Gibbons says.

The scientists then used the genetic engineering technology, CRISPR, to delete those candidate genes from the genome, creating gene-deletion mutants and enabling the researchers to determine that two of the genes were involved in the paradoxical effect.

It looks like there are many genes and many genetic variants that contribute to this phenotype, Gibbons says. We arent done yet. One idea is that we could potentially generate new drug targets if we find the full collection of genes. We dont understand the mechanisms yet.

Ultimately the team hopes they can use DNA sequencing to understand the genetic basis of different phenotypes in general and to predict for clinical benefits if a patient sample of A. fumigatus has a genotype that is associated with the paradoxical effect.

That would be an important tool that could really improve treatment, Gibbons says.

Link:
Genomic Research Aids in the Effort to Understand How Best to Treat Deadly Infections Caused by a Fungus - UMass News and Media Relations

Douglas Insights

The key players in the market currently include Scientific Genomics Inc, Thermo Fischer Scientific, Blue Heron, TeselaGen, GenScript, DNA2.0, Integrated DNA Technologies, Eurofins Scientific, Inc, Editas Medicine Inc., among others.

Isle of man, Oct. 10, 2022 (GLOBE NEWSWIRE) -- The Douglas Insights Search Engine is the worlds first engine that offers comparative market analysis, and it has also recently addedSynthetic Biologyto the database. Market analysts, industry specialists, business personnel, and all relevant entities can make use of this comparative engine to identify the drivers, hindrances, obstacles, limitations, and opportunities for growth in each market. With the help of these insights, future market predictions can also be made. The engine users will be able to sort the relevant information by price, publication date, publisher rating, and table of contents, all of which will make access easier.

Synthetic biology refers to using lab-generated technology to help with biological processes and concerns. Synthetic biology refers to the development of testing kits, vaccines, treatments, and infectious diseases. In fact, synthetic biology played a key element in the Covid-19 pandemic as well. The development of the vaccine was accelerated, and new technology was used for vaccine development, showing how Synthetic integral biology was to the ordeal. Other than medical applications, the industry also helps to further develop the food and agriculture industry through genetic engineering and genome synthesis and helps industries by manufacturing Biofuels, biomaterials, industrial enzymes, and other useful products.

There are many drivers in the field of synthetic biology due to its need in the current era. For example, the wide range of applications of synthetic biology is one of the main factors driving the market growth. Synthetic biology can be applied to various industries, including food and agriculture, industrial work, and of course, many medical applications. The medical applications of synthetic biology will be driving the market the most.

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Other than that, the market will also continue to grow due to the increased funding of research and development projects by many governments. This funding will fuel research into the industry and allow for more applications of synthetic biology to arise moving forward. One example is biofuels, which will be much more common and necessary for the environment in the coming years as well.

However, there are still quite a few factors that are currently restricting market growth. These include biosafety, ethical, and security concerns regarding biological safety. One example of ethical and safety concerns is the possible intentional or unintentional introduction of synthetic organisms into ecosystems which can cause great disruption. These organisms can also breed with naturally occurring microorganisms, causing hybrid species to be released and hampering the environment as we know it. In fact, this is one of the ways in which antibiotic-resistant microorganisms can also be generated.

The largest market share of synthetic biology goes to North America. This is because it is the hub of most of the market's key players and has the most funding for medically forward projects. Other than that, Europe and the Asia Pacific also have large shares in the market and will use them for further development in the arena.

The key players in the market currently include Scientific Genomics Inc, Thermo Fischer Scientific, Blue Heron, TeselaGen, GenScript, DNA2.0, Integrated DNA Technologies, Eurofins Scientific, Inc, Editas Medicine Inc., among others. These players are working on further developments while also adding to the industry at present.

The tools currently used in the synthetic biology market include enzymes, Oligonucleotides, synthetic DNA, Synthetic cells, cloning technology, xeno nucleic acids, and chassis organisms. The technology being used in the market at present includes gene synthesis and genetic engineering, cloning, bioinformatics, sequencing, nanotechnology, micro fluids, among many others.

Key questions answered in this report

COVID 19 impact analysis on global Synthetic Biology industry.

What are the current market trends and dynamics in the Synthetic Biology market and valuable opportunities for emerging players?

What is driving Synthetic Biology market?

What are the key challenges to market growth?

Which segment accounts for the fastest CAGR during the forecast period?

Which product type segment holds a larger market share and why?

Are low and middle-income economies investing in the Synthetic Biology market?

Key growth pockets on the basis of regions, types, applications, and end-users

What is the market trend and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?

Unique data points of this report

Statistics on Synthetic Biology and spending worldwide

Recent trends across different regions in terms of adoption of Synthetic Biology across industries

Notable developments going on in the industry

Attractive investment proposition for segments as well as geography

Comparative scenario for all the segments for years 2018 (actual) and 2031 (forecast)

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Computational Biology Market: The computational biology market is growing rapidly due to the increasing demand for personalized medicine and drug development, and the need for early diagnosis of diseases. Computational biology is the study of biological processes using computational techniques.

Industrial Microbiology Market: Industrial microbiology is the study of microorganisms that are useful in the production of food, chemicals, pharmaceuticals, and other industrial products. The demand for industrial microbiology is driven by the need for efficient and eco-friendly production processes, as well as the need for improved product quality.

Automated Microbiology Market: This market is primarily driven by the increasing demand for rapid and accurate detection of microorganisms in food, water, and pharmaceuticals. The rising incidents of foodborne illnesses and the increasing stringent regulations regarding food safety are also fueling the growth of this market.

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Synthetic Biology Market is Expected to Report a CAGR of ~21% from 2021 to 2029: Industry Size, Growth & Forecast at Douglas Insights - Yahoo...

There is no doubt that GMOs are beneficial to us, but there is sufficient data to demonstrate that GMOs have great potential for harm too.[Istockphoto]

The debate on Genetically Modified Organisms (GMOs) is upon us again and is still emotive and quite divisive.

Although we have more research, we still cannot be absolutely certain that we have adequate science to fully support GM foods. Genetic engineering (also called genetic modification of organisms - GMOs) uses laboratory-based technologies to alter the DNA makeup of an organism. This may involve changing a single base pair (A-T or C-G), deleting a region of DNA or adding a new segment of DNA.

This happens when a scientist tweaks a gene to create a more desirable organism by taking DNA from organism A and inserting it in organism B to improve it. The result is known as recombinant (a combination of DNAs of two organisms) or in cases of drugs the modified drug is known as transgenic. There are many reasons why organisms are genetically modified. For example, to make them more resistant to diseases, insects/bugs or to make them mature/ripen faster, stronger, bigger, better, sweater. For example, food crops have been modified by food engineers to be resistant to specific bugs, bad weather or to grow faster.

Genetic engineering is very different from cloning. Cloning is the process of creating a genetically identical copy or duplication of a cell or an organism. It has far-reaching ethical concerns although people tend to confuse the two, especially when criticising GMOs.

There are many persuasive arguments for and against GMOs. There is no doubt that GMOs are beneficial to us, but there is sufficient data to demonstrate that GMOs have great potential for harm too. Those who support GMOs have advanced persuasive arguments that genetic engineering can help us cure diseases, ensure food security and nutrition, improve the quality of lives and well-being and even lengthen our lives. For example, most drugs such as insulin and vaccinations are all genetically modified or engineered, without which many people would die. There are also ethical, safety and environmental concerns about GMOs.

No side of the argument for or against, can state with absolute certainty that GMOs are devoid of risks and concerns or they are all bad for us. The question is, can scientists guarantee that there will be no side effects after consuming GM foods? Or that huge multinational companies will ensure environmental and safety requirements are complied with when they come to Kenya?

The potential for abuse of GMOs has necessitated very elaborate checks and controls at both international and national levels. The issue of concern now is, does Kenya have such elaborate and well-resourced checks and controls in place? According to the National Biosafety Authority (NBA), Kenya has robust policy, legislative and institutional mechanisms to implement biotechnology innovations having ratified the Cartagena Protocol on Biosafety in 2003 and approved the National Policy on Biotechnology Development in 2006 to guide research and commercialization of modern biotechnology products.

The Biosafety Act, 2009 provides for the legal and institutional frameworks governing modern biotechnology which are implemented by the NBA established under the Act in 2010. The NBA developed regulations in 4 areas; contained use, environmental release, export, import and transit; all three in 2011 and for labeling in 2012. The NBA says it has put in place GM safety assessment with the goal to provide assurance that GM foods do not cause harm based on their best available scientific knowledge, although, we are not so certain that we indeed have that best scientific knowledge available so far.

The NBA indicates that, research on genetic modification is done under appropriate experimental conditions; open cultivation of genetically modified crops is safe for human health and the environment; they ensure safe movement of genetically modified materials in and out of the country and ensure accurate consumer information and traceability of genetically modified products in the food supply chain.

They say that they do this through collaboration with other eight bodies in Kenya, including KEBs. Because GMOs require very careful scientific monitoring and control, it is important to ensure that open cultivation is done in phases and only on a case-by-case basis at a time.

Continued here:
Farmers, consumers will embrace GMOs if they understand them - The Standard