美国FDA食品检查制度对中国的启示

总结了美国FDA食品检查制度的特点,并结合我国现状,提出加快完善食品检查制度顶层设计、加强职业化食品检查员队伍建设、创新智能检查方式、重视监管科学发展等建议,以期进一步完善我国食品检查制度。     

国际转基因食品安全评价政策及启示

转基因技术作为现代生物技术的核心之一,在保障粮食安全、保护生态安全、拓展农业功能等方面发挥了重要作用,但同时,也带来了潜在的安全性问题。为此,世界上主要国家和国际组织都制定了与转基因生物安全管理相关的法律法规,加强管理。通过对国际食品法典委员会（Codex Alimentarius Commission, CAC）、经济合作与发展组织（Organization for Economic Co-operation and Development, OECD）的转基因食品安全评价体系与评价政策进行介绍分析,总结其现实积极作用及价值,指出其缺陷或不足,以期为健全我国转基因食品安全评价体系、完善监管措施,提供理论政策及法律规范方面的参考性建议。     

美国监管对用生物技术改良作物程序的评价Ⅱ产品进入市场后的监管及对未来研究和发展的建议

在一个新的生物技术改良植物品种被监管机构批准并进入商业化以后,最好检验一下或者需要检验一下该品种用现代生物技术导人的诸多特征是否存在。作为质量保证程序的要素,检测和跟踪也必须进行的。进口国规定需要检验,或者必需检验,以便确定是否符合买方规定的产品规格(特别是在产品标有“不含生物技术”的情况下)。所以,     

美国有机农业发展及对我国的启示

美国有机农业起步较早、发展迅速,已经成为全球有机农产品第一大消费市场,分析美国有机农业起源、发展、标识管理和财政支持对发展我国有机农业、提高我国农产品质量安全具有重要借鉴意义。     

美国对科学教科书中科学素养的评价及其启示

介绍了美国为实现“2061计划”,以“科学素养”为目标对科学教科书进行评价的历史背景、评价内容和成果。提出了我国在基础教育课程改革和教材改革中,应提高对教科书评价的重视,以“科学素养”为主要的评价目标,设计有效、完善、简便的评价工具的初步构想。     

美国生物工程食品信息披露制度的新变化及启示

2018年12月,美国农业部公布了《国家生物工程食品信息披露标准(实施细则)》,就美国生物工程食品信息披露制度的具体内容进行细化和完善,标志着美国生物工程食品信息披露制度基本建立。该文本主要包含以下几方面内容:增加可检测性条件、统一生物工程食品信息披露豁免条件、完善生物工程食品信息披露形式、设置自愿标识,以及生物工程食品信息披露主体的义务。通过分析发现,在法定标识的前提下,美国依旧秉持实质等同原则,在保护消费者知情权的同时确保标识制度的平稳过渡。针对我国转基因食品标识的乱象,借鉴美国经验,提出我国转基因食品标识制度在理念、标识对象、管理机构和豁免等方面的完善建议。     

美国生物工程食品信息披露制度的新变化及启示

2018年12月,美国农业部公布了《国家生物工程食品信息披露标准(实施细则)》,就美国生物工程食品信息披露制度的具体内容进行细化和完善,标志着美国生物工程食品信息披露制度基本建立.该文本主要包含以下几方面内容:增加可检测性条件、统一生物工程食品信息披露豁免条件、完善生物工程食品信息披露形式、设置自愿标识,以及生物工程食...     

美国、欧盟和中国生物技术药物的比较

按照相同表达系统表达的相同氨基酸序列的产品视为同种产品,而不同表达系统表达的相同氨基酸序列的产品视为不同产品的原则,归纳总结了美国、欧盟和中国已批准上市的生物技术药物。美国FDA批准的以基因工程产品、抗体工程产品和细胞工程产品为主要代表的生物技术药物共79种(18种为大肠杆菌表达,8种为酵母表达,53种为哺乳动物细胞培养生产),其中基因重组蛋白质药物为64种。欧盟批准了49种基因重组酶、激素或细胞因子,11种基因重组治疗性抗体和5种基因重组疫苗。在欧美60％-70％的产品由哺乳动物细胞表达。中国批准了27种生物技术药物。比较了美国、欧盟和中国生物制药的特点。     

蓖麻生物工程研究进展

蓖麻是一种高蓄能植物和工业原料植物,具有很大的开发利用价值。本文从组织培养和遗传转化两个方面并结合本实验室的工作综述了蓖麻生物工程研究的最新进展。在蓖麻组织培养方面,不同的外植体中以成熟种子的胚轴最适宜,而在不同激素中以TDZ诱导丛生芽的效率最高,并以此为基础建立了蓖麻离体再生体系。在遗传转化方面,不同的转化方法中以农杆菌介导法最适合蓖麻转化。蓖麻胚轴对卡那霉素不敏感,潮霉素是蓖麻转化的适宜筛选剂。文中指出了蓖麻生物工程研究中存在的问题,并对应用生物技术培育蓖麻新品种和促进蓖麻生产的可能性进行了讨论。     

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

Selectable marker gene systems are vital for the development of transgenic crops. Since the creation of the first transgenic plants in the early 1980s and their subsequent commercialization worldwide over almost an entire decade, antibiotic and herbicide resistance selectable marker gene systems have been an integral feature of plant genetic modification. Without them, creating transgenic crops is not feasible on purely economic and practical terms. These systems allow the relatively straightforward identification and selection of plants that have stably incorporated not only the marker genes but also genes of interest, for example herbicide tolerance and pest resistance. Bacterial antibiotic resistance genes are also crucial in molecular biology manipulations in the laboratory. An unprecedented debate has accompanied the development and commercialization of transgenic crops. Divergent policies and their implementation in the European Union on one hand and the rest of the world on the other (industrialized and developing countries alike), have resulted in disputes with serious consequences on agricultural policy, world trade and food security. A lot of research effort has been directed towards the development of marker-free transformation or systems to remove selectable markers. Such research has been in a large part motivated by perceived problems with antibiotic resistance selectable markers; however, it is not justified from a safety point of view. The aim of this review is to discuss in some detail the currently available scientific evidence that overwhelmingly argues for the safety of these marker gene systems. Our conclusion, supported by numerous studies, most of which are commissioned by some of the very parties that have taken a position against the use of antibiotic selectable marker gene systems, is that there is no scientific basis to argue against the use and presence of selectable marker genes as a class in transgenic plants.     

Biorefinery: Toward an industrial metabolism

Fossil fuel reserves are running out, global warming is becoming a reality, waste recycling is becoming ever more costly and problematic, and unrelenting population growth will require more and more energy and consumer products. There is now an alternative to the 100% oil economy; it is a renewable resource based on agroresources by using the whole plant. Production and development of these new products are based on biorefinery concept. Each constituent of the plant can be extracted and functionalized in order to produce non-food and food fractions, intermediate agro-industrial products and synthons. Three major industrial domains can be concerned: molecules, materials and energy. Molecules can be used as solvent surfactants or chemical intermediates in substitution of petrol derivatives. Fibers can be valorized in materials like composites. Sugars and oils are currently used to produce biofuels like bioethanol or biodiesel, but second-generation biofuels will use lignocellulosic biomass as raw material. Lipids can be used to produce a large diversity of products like solvent, lubricants, pastes or surfactants. Industrial biorefinery will be linked to the creation of new processes based on the twelve principles of green chemistry (clean processes, atom economy, renewable feedstocks…). Biotechnology, especially white biotechnology, will take a major part into these new processes with biotransformations (enzymology, micro-organisms…) and fermentation. The substitution of oil products by biobased products will develop a new bioeconomy and new industrial processes respecting the sustainable development concept. Industrial biorefinery can be developed on the principle that any residues of one can then be exploited as raw material by others in an industrial metabolism.     

农作物抗除草剂基因工程

概述抗除草剂作物基因工程抗性基因的来源,产生抗性的机理,抗除草剂外源基因的导入方法,并对目前普遍关注的抗除草剂作物的安全性问题进行了讨论,提出了抗除草剂作物研究及开发中应注意的问题。     

Needs for new plant-derived pharmaceuticals in the post-genome era: an industrial view in drug research and development

Plant metabolites have been the successful source of drugs and provided considerable value not only to the pharmaceutical industry but also to human health problems. Although pharmaceutical companies significantly decreased their activities in natural product discovery during the past few decades, various multidisciplinary approaches have been made to create new opportunities for finding innovative plant derived pharmaceuticals in post-genome era. Strategies to integrate the knowledge on medicinal plants into rational drug screening, the unique biodiversity of plant metabolites into random drug screening, and the chemical diversity of plant metabolites into combinatorial chemistry have been reviewed with concrete examples. Innovative biotechnologies in plant cell and tissue cultures, and the latest achievements in metabolic engineering and genetic modification should significantly improve the production sustainability and efficiency of plant-derived pharmaceuticals.     

脂肪酶抑制剂应用于抗肥胖的研究进展

肥胖易引发各种慢性代谢疾病,肥胖在全球的迅速流行引起了人们的关注。脂肪酶抑制剂作为一种作用于肠道内的减肥药物,不进入血液,不会产生中枢神经性副作用,不影响矿物质代谢,是近年来研究的热点。而各种植物提取物作为脂肪酶抑制剂的来源,具有非常巨大的潜力,以其更高的安全性,更广泛的来源,日后必将在新型减肥药品或保健品开发中占有重要的一席之地。本文主要就脂肪酶抑制剂的性质和应用于减肥领域的进展作一简要综述。     

Tissue culture of ornamental pot plant: a critical review on present scenario and future prospects

Recent modern techniques of propagation have been developed which could help growers to meet the demand of the horticultural industry in the next century. An overview on the in vitro propagation via thin cell layer, meristem culture, regeneration via organogenesis and somatic embryogenesis is presented. Available methods for the transfer of genes could significantly simplify the breeding procedures and overcome some of the agronomic and environmental problems, which other wise would not be achievable through conventional propagation methods. The development and remarkable achievements with biotechnology in ornamental pot plants made during the three decades have been reviewed. The usefulness of the pot plants in commercial industry as well as propagation techniques, screening for various useful characteristics and selection of somaclonal variation is also discussed.