genetically modified organisms

转基因生物
  • 文章类型: Journal Article
    埃斯瓦蒂尼王国是《生物多样性公约》和《卡塔赫纳生物安全议定书》的缔约国。作为派对,埃斯瓦蒂尼通过《生物安全法》将这些协议归化,2012年的规定,以提供安全处理,转让,以及在该国使用改性活生物体(LMOs)。该法规定了用于密闭田间试验的改性活生物体,商业发布,进口,export,和过境,和食物,饲料,和处理。在向主管当局提出任何申请之前,将为潜在申请人提供指导。该框架还提供了对合成生物学和基因组编辑等新兴技术的调节。改性活生物体监管框架旨在为该国预防性使用现代生物技术及其产品提供有利环境,以保护生物多样性和人类健康。
    The Kingdom of Eswatini is a Party to the Convention on Biological Diversity and to the Cartagena Protocol on Biosafety. As Party, Eswatini has domesticated these agreements by passing the Biosafety Act, of 2012 to provide for the safe handling, transfer, and use of living modified organisms (LMOs) in the country. The Act regulates living modified organisms to be used for confined field trials, commercial release, import, export, and transit, and for food, feed, and processing. Guidance is provided for prospective applicants before any application is made to the Competent Authority. This framework also provides for the regulation of emerging technologies such as synthetic biology and genome editing. The regulatory framework for living modified organisms aims to provide an enabling environment for the precautionary use of modern biotechnology and its products in the country in order to safeguard biological diversity and human health.
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  • 文章类型: Journal Article
    作为转基因(GM)植物风险评估(RA)要求的一部分,根据法规(EU)No503/2013和EFSA关于转基因植物食品和饲料的RA的指南(EFSAGMO小组2011),申请人需要对插入到转基因植物基因组中的DNA序列进行分子表征。给申请人的本技术说明将方法质量评估的要求和建议放在一起,当DNA测序用于转基因植物的分子表征时,分析和报告。特别是,它适用于使用Sanger测序和下一代测序来表征插入的遗传物质及其在每个插入位点的侧翼区,测定所有可检测的插入物的拷贝数和分析插入物的遗传稳定性。此更新文件取代了EFSA2018技术说明,并反映了用于生成和验证的科学技术方法的当前知识,以标准化的方式,转基因植物RA背景下的DNA测序数据。它没有考虑到检测方法的验证和验证,这仍然在联合研究中心(JRC)的职权范围内。
    As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. This Technical Note to the applicants puts together requirements and recommendations for the quality assessment of the methodology, analysis and reporting when DNA sequencing is used for the molecular characterisation of GM plants. In particular, it applies to the use of Sanger sequencing and next-generation sequencing for the characterisation of the inserted genetic material and its flanking regions at each insertion site, the determination of the copy number of all detectable inserts and the analysis of the genetic stability of the inserts. This updated document replaces the EFSA 2018 Technical Note and reflects the current knowledge in scientific-technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. It does not take into consideration the verification and validation of the detection method which remains under the remit of the Joint Research Centre (JRC).
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  • 文章类型: Journal Article
    本研究分析了巴拉圭的生物技术监管框架及其与生物技术进步中的国际标准的一致性。它还确定了提高框架效力的改进领域。通过这项工作,我们的目标是为政策制定者提供资源,利益相关者,和研究人员浏览巴拉圭的生物技术法规。
    This study analyzes Paraguay\'s biotechnology regulatory framework and its alignment with international standards amid biotechnological advancements. It also identifies areas of improvement for enhancing framework effectiveness. Through this work, we aim to provide a resource for policymakers, stakeholders, and researchers navigating Paraguay\'s biotechnology regulation.
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  • 文章类型: Journal Article
    标签是市场上有影响力的信号,旨在告知并消除买家的困惑。尽管如此,食品标签仍然是争论的话题。没有比非转基因(转基因生物)标签更多。该手稿提供了转基因标签演变的时间表,从反转基因运动的早期历史开始,到美国当前的国家生物工程食品披露标准。使用通过Buzzsumo™和Mintel™收集的媒体和市场情报数据,对转基因生物的公共话语进行了分析,涉及社会政治事件和带有反转基因标签的新食品的数量,分别。通过Overton™收集政策文档和发布数据,以说明GMO主题的政策格局及其随时间的变化。对集体数据的分析表明,尽管围绕转基因生物主题的社交媒体和政策参与随着时间的推移而减少,无转基因产品的数量持续增长。虽然话语在某一时刻达到顶峰,此后下降了,我们的结果表明,反转基因叙事的遗产仍然牢牢地嵌入在社会心理学中,无转基因产品的持续增长证明了这一点。为满足消费者的知情权而开展的转基因食品标签宣传活动是成功的,对这些信息的感知需求现在似乎是自我维持的。
    Labels are influential signals in the marketplace intended to inform and to eliminate buyer confusion. Despite this, food labels continue to be the subject of debate. None more so than non-GMO (genetically modified organisms) labels. This manuscript provides a timeline of the evolution of GMO labels beginning with the early history of the anti-GMO movement to the current National Bioengineered Food Disclosure Standard in the United States. Using media and market intelligence data collected through Buzzsumo™ and Mintel™, public discourse of GMOs is analyzed in relation to sociopolitical events and the number of new food products with anti-GMO labels, respectively. Policy document and publication data is collected with Overton™ to illustrate the policy landscape for the GMO topic and how it has changed over time. Analysis of the collective data illustrates that while social media and policy engagement around the topic of GMOs has diminished over time, the number of new products with a GMO-free designation continues to grow. While discourse peaked at one point, and has since declined, our results suggest that the legacy of an anti-GMO narrative remains firmly embedded in the social psyche, evidenced by the continuing rise of products with GMO-free designation. Campaigns for GMO food labels to satisfy consumers\' right to know were successful and the perceived need for this information now appears to be self-sustaining.
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  • 文章类型: Journal Article
    术语新基因组技术(NGT)是一个总称,用于描述各种技术,这些技术可以改变生物体的遗传物质,并且自2001年现有的转基因生物(GMO)立法以来已经出现或已经开发通过。用于检测欧洲转基因生物的分析框架是一个既定的单一协调程序,对于转基因食品和饲料的授权是强制性的,从而产生一个可靠的,透明,和有效的GMO产品标签计划。然而,NGT产品可以挑战欧盟现行监管体系的实施和执行,特别涉及检测不含外来遗传物质的NGT产品。因此,当前的检测方法可能无法满足最低性能要求。尽管现有的检测方法可能能够检测和量化基因组中的微小变化,这并不一定确认受GMO法规约束的NGT产品与其他产品之间的区别。因此,本研究通过测试当前基因组数据库中扩增子和引物集搜索的生物信息学管道,为PCR系统特异性的计算机模拟预测提供了一种逐步的方法.此外,它还根据经验测试了在计算机分析期间评估的PCR系统。CRISPR-Cas9在拟南芥中产生的两种突变基因型被用作案例研究。总的来说,我们的结果表明,为识别grf1-3基因型中的核苷酸插入而开发的单个PCR系统在数据库中具有多个匹配,这不能区分这种突变事件。经验分析进一步支持这种证明。相比之下,第二个突变的基因型,grf8-61,包含一个-3bp的缺失,在序列变体数据库中未产生任何匹配。然而,在经验测定期间引物序列效率不高。我们的方法代表了NGT检测分析方法决策的第一步,identification,并根据欧洲标签法规进行量化。
    The term new genomic techniques (NGTs) is an umbrella term used to describe a variety of techniques that can alter the genetic material of an organism and that have emerged or have been developed since 2001, when the existing genetically modified organism (GMO) legislation was adopted. The analytical framework used to detect GMOs in Europe is an established single harmonized procedure that is mandatory for the authorization of GM food and feed, thus generating a reliable, transparent, and effective labeling scheme for GMO products. However, NGT products can challenge the implementation and enforcement of the current regulatory system in the EU, relating in particular to the detection of NGT products that contain no foreign genetic material. Consequently, the current detection methods might fail to meet the minimum performance requirements. Although existing detection methods may be able to detect and quantify even small alterations in the genome, this does not necessarily confirm the distinction between products resulting from NGTs subject to the GMO legislation and other products. Therefore, this study provides a stepwise approach for the in silico prediction of PCR systems\' specificity by testing a bioinformatics pipeline for amplicon and primer set searches in current genomic databases. In addition, it also empirically tested the PCR system evaluated during the in silico analysis. Two mutant genotypes produced by CRISPR-Cas9 in Arabidopsis thaliana were used as a case study. Overall, our results demonstrate that the single PCR system developed for identifying a nucleotide insertion in the grf1-3 genotype has multiple matches in the databases, which do not enable the discrimination of this mutated event. Empirical assays further support this demonstration. In contrast, the second mutated genotype, grf8-61, which contains a -3 bp deletion, did not yield any matches in the sequence variant database. However, the primer sequences were not efficient during the empirical assay. Our approach represents a first step in decision making for analytical methods for NGT detection, identification, and quantification in light of the European labeling regulations.
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  • 文章类型: Journal Article
    转基因生物(GMOs)的扩散给转基因检测实验室和政策制定者带来了挑战。传统方法,如定量实时PCR(qPCR),在量化单个样本中不断增加的转基因生物数量方面面临局限性。数字PCR(dPCR),特别是多路复用,通过实现多个GMO目标的同时量化提供解决方案。这项研究探索了Naica六色CrystaldPCR平台在单个六重测定中定量五个转基因大豆品系的使用。还开发了两种四色测定法以增加灵活性。这些试验证明了高特异性,灵敏度(检测限或每个反应的LOD<25个拷贝)和精密度(偏向于估计的拷贝数浓度<15%)。此外,实施了两种优化数据分析的方法。通过应用空白限制(LOB)校正,可以更精确地确定定量限(LOQ)和LOD。汇集反应额外降低了LOD,灵敏度提高了两到八倍。来自常规测试的真实样品用于确认定量复杂样品中转基因大豆品系的测定适用性。本研究展示了六色CrystaldPCR平台彻底改变GMO测试的潜力,促进对复杂样品中转基因生物的综合分析。
    The proliferation of genetically modified organisms (GMOs) presents challenges to GMO testing laboratories and policymakers. Traditional methods, like quantitative real-time PCR (qPCR), face limitations in quantifying the increasing number of GMOs in a single sample. Digital PCR (dPCR), specifically multiplexing, offers a solution by enabling simultaneous quantification of multiple GMO targets. This study explores the use of the Naica six-color Crystal dPCR platform for quantifying five GM soybean lines within a single six-plex assay. Two four-color assays were also developed for added flexibility. These assays demonstrated high specificity, sensitivity (limit of detection or LOD < 25 copies per reaction) and precision (bias to an estimated copy number concentration <15%). Additionally, two approaches for the optimization of data analysis were implemented. By applying a limit-of-blank (LOB) correction, the limit of quantification (LOQ) and LOD could be more precisely determined. Pooling of reactions additionally lowered the LOD, with a two- to eight-fold increase in sensitivity. Real-life samples from routine testing were used to confirm the assays\' applicability for quantifying GM soybean lines in complex samples. This study showcases the potential of the six-color Crystal dPCR platform to revolutionize GMO testing, facilitating comprehensive analysis of GMOs in complex samples.
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  • 文章类型: Journal Article
    许多生物伦理学作家,科学,医学认为,胚胎选择在道德上比基因编辑更好地避免遗传疾病,因为后者有前者没有的风险。我们认为,使用基因编辑的一个原因是,在许多情况下,这对从编辑的胚胎发育的人来说会更好,所以如果不这样做,对那个人来说会更糟。相比之下,胚胎选择是从来没有更好的人从选定的胚胎发育。这个原因使用基因编辑,然而,受到两个挑战:第一,这没什么区别,道德上,坏的效果是否对某人更糟糕,或对某人更好的效果;并且,第二,对于从编辑的胚胎发育的人来说,这种有益的基因编辑不会明确地更好。我们认为,这两个反对意见都可以得到令人满意的回答,因此确实有一个重要的道德原因,至少在某些情况下,使用基因编辑而不是胚胎选择。
    Many writers in bioethics, science, and medicine contend that embryo selection is a morally better way of avoiding genetic disorders then gene editing, as the latter has risks that the former does not. We argue that one reason to use gene editing is that in many cases it would be better for the person who would develop from the edited embryo, so that not to have done it would have been worse for that person. By contrast, embryo selection is never better for the person who develops from the selected embryo. This reason to use gene editing has, however, been challenged on two grounds: first, that it makes no difference, morally, whether a bad effect is worse for someone, or a good effect better for someone; and, second, that beneficent gene editing would not be unequivocally better for the person who would develop from the edited embryo. We argue that both of these objections can be satisfactorily answered and thus that there is indeed a significant moral reason, at least in some cases, to use gene editing rather than embryo selection.
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  • 文章类型: Journal Article
    由于它们能够迅速增加频率,基因驱动可用于在驱动个体初始释放后修饰或抑制目标群体。最近的进步揭示了不同类型驱动器的许多可能性,其中一些已经在实验中实现。这些驱动器具有与它们的构造简易性相关的优点和缺点。限制和容量用于修改或抑制。尽管在建模研究中已经探索了这些驱动器的特征,在连续空间环境中的评估受到限制,经常关注结果而不是基本属性。这里,我们对许多不同的基因驱动类型进行了比较分析,这些基因驱动类型有能力在连续空间中使用基于个体的模拟在连续空间中形成一波前进。我们评估驱动波速度作为驱动性能和生态参数的函数,这揭示了大众环境与空间环境中驱动器性能之间的实质性差异。特别是,我们发现,由于母体沉积,抑制驱动波对胚胎中的适应性成本和不期望的CRISPR卵裂活性具有独特的脆弱性.一些驱动器,然而,即使效率参数变化很大,也能保持稳健的性能。为了更好地了解驱动波,我们比较了它们的恐慌表现,发现野生型等位基因的去除率与驱动波速度相关,尽管这也受到其他因素的影响。总的来说,我们的结果为理解空间连续环境中驱动器的性能提供了有用的资源,这可能是许多相关场景中潜在驱动器部署的最具代表性的。
    With their ability to rapidly increase in frequency, gene drives can be used to modify or suppress target populations after an initial release of drive individuals. Recent advances have revealed many possibilities for different types of drives, and several of these have been realized in experiments. These drives have advantages and disadvantages related to their ease of construction, confinement and capacity to be used for modification or suppression. Though characteristics of these drives have been explored in modelling studies, assessment in continuous space environments has been limited, often focusing on outcomes rather than fundamental properties. Here, we conduct a comparative analysis of many different gene drive types that have the capacity to form a wave of advance in continuous space using individual-based simulations in continuous space. We evaluate the drive wave speed as a function of drive performance and ecological parameters, which reveals substantial differences between drive performance in panmictic versus spatial environments. In particular, we find that suppression drive waves are uniquely vulnerable to fitness costs and undesired CRISPR cleavage activity in embryos by maternal deposition. Some drives, however, retain robust performance even with widely varying efficiency parameters. To gain a better understanding of drive waves, we compare their panmictic performance and find that the rate of wild-type allele removal is correlated with drive wave speed, though this is also affected by other factors. Overall, our results provide a useful resource for understanding the performance of drives in spatially continuous environments, which may be most representative of potential drive deployment in many relevant scenarios.
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  • 文章类型: Journal Article
    基因编辑工具已成为细胞生物学基本方面研究不可或缺的一部分。基于下一代测序技术产生了大量文献,跟踪这个不断增长的信息仍然具有挑战性。这就需要将基因组数据转化为实际应用。为了实现这一目标,生成的下一代测序(NGS)数据构成了靶向基因组编辑策略的基础,使用已知的各种细胞机制的酶,产生具有特定表型的生物体。这篇综述主要集中在CRISPR/Cas9技术的背景下,其优势优于锌指蛋白(ZNF)和转录激活因子样效应核酸酶(TALEN)和大范围核酸酶诱变策略,用于农业和兽医应用。这篇综述将描述CRISPR/Cas9在创建具有定制属性的修饰生物中的应用,没有与病毒载体疫苗和细菌系统中产生的生物活性分子相关的不期望的非靶向作用。这种技术成功和不成功应用于植物的例子,提供动物和微生物,以及深入研究疫苗开发中可能的未来趋势和应用,将讨论抗病性和增强的表型性状。
    Gene editing tools have become an indispensable part of research into the fundamental aspects of cell biology. With a vast body of literature having been generated based on next generation sequencing technologies, keeping track of this ever-growing body of information remains challenging. This necessitates the translation of genomic data into tangible applications. In order to address this objective, the generated Next Generation Sequencing (NGS) data forms the basis for targeted genome editing strategies, employing known enzymes of various cellular machinery, in generating organisms with specifically selected phenotypes. This review focuses primarily on CRISPR/Cas9 technology in the context of its advantages over Zinc finger proteins (ZNF) and Transcription activator-like effector nucleases (TALEN) and meganucleases mutagenesis strategies, for use in agricultural and veterinary applications. This review will describe the application of CRISPR/Cas9 in creating modified organisms with custom-made properties, without the undesired non-targeted effects associated with virus vector vaccines and bioactive molecules produced in bacterial systems. Examples of the successful and unsuccessful applications of this technology to plants, animals and microorganisms are provided, as well as an in-depth look into possible future trends and applications in vaccine development, disease resistance and enhanced phenotypic traits will be discussed.
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  • 文章类型: Journal Article
    收到更多个人相关信息的人们有动力更加关注信息并积极处理信息,最终可能会刺激行为改变。因此,首选信息内容已在许多学科中使用,以促进有效的沟通。然而,没有研究探讨首选信息格式的影响(例如,字,信息图,和视频)关于食品生产。随着生物技术在食品生产中的应用越来越多,一个需要沟通的复杂话题,有证据表明消费者愿意为生物工程食品支付更少的费用,有效的沟通对影响消费者偏好很重要。这项研究的结果表明,消费者最喜欢的信息格式是写作。以视频格式提供信息确实提高了消费者对食品生物技术信息的信任。然而,以消费者的首选格式接收信息并没有显著改变消费者对基因工程橙汁的WTP。
    People who received a more personally relevant message were motivated to pay closer attention to the information and actively process it, which ultimately may stimulate behavioral changes. Therefore, preferred information content has been used in many disciplines to promote effective communication. However, no study has explored the impact of preferred information formats (e.g., word, infographic, and video) concerning food production. With the increasing application of biotechnology to food production, a complex topic to communicate, and evidence that consumers were willing to pay less for bioengineered foods, efficient communication was important to impact consumer preferences. The results of this study showed that consumers mostly preferred information format is writing. Providing information in video format did improve consumers\' trust in information about food biotechnology. However, receiving information in consumers\' preferred formats did not significantly change consumers\' WTP for genetically engineered orange juice.
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