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,     

全局转录机器工程——工业生物技术新方法

美国和英国的研究人员在2006年1月出版的<科学>杂志上发表文章称: 工业生物技术是一种新的工业制造概念……并将成为一种新的制造技术典 范①.采用以微生物酶或细胞为主体的工业生物技术生产大宗化学品和能源、材料、医药产品,已经成为全世界--尤其是我国解决资源、能源和环境危机的重要手段②.     

日本对植物性转基因食品的安全管理

转基因食品的安全问题已在全世界范围内成为人们聚焦的热点 ,许多国家的政府正忙于制定转基因食品安全管理的指导方针 ,我国目前也在准备建立转基因食品的安全性评价体系。 2 0 0 0年 4月初在北京召开的“中国农业与生物技术国际研讨会”上 ,日本学者ＨＩＮＯ博士介绍了日本的转基因食品标签体系和检测技术 ,值得我国的学者和管理人员借鉴。现经其同意 ,将报告内容及其它相关资料做一简介。1　日本的ＧＭＯ安全评定管理规则由于生物技术的快速发展 ,日本国内市场上已有许多商品化生产的转基因作物及其产品 (包括转基因食品 )。因此 ,日本政…     

基于CRISPR/Cas原理的转基因产品检测技术研究进展

随着转基因产品商业化种植面积不断增加、国际贸易日趋频繁,对转基因生物安全管理提出了更高的要求。转基因产品检测技术作为安全评价的关键环节,逐渐引起了各国政府的关注。目前,针对转基因产品的快速检测方法层出不穷,但这些检测方法对于设备、试剂和专业的实验人员均有较高的要求。因此,为了有效支撑转基因相关产业的发展和管理,亟需建立一种高灵敏度、高特异性及高效的转基因检测技术。基因组编辑技术是近年来迅速发展的一类遗传修饰技术,其代表技术——CRISPR/Cas技术,更是极大地推动了生物技术的发展。CRISPR/Cas技术除了被应用于基因编辑领域,也逐渐被应用于核酸分子检测领域。基于此,以转基因产品检测技术为立足点,从CRISPR/Cas的检测原理、检测效果等技术层面分析了CRISPR/Cas检测技术发展的必然性,并对其在转基因产品检测上的应用前景进行展望,旨在为我国转基因产品快速检测和有效监管工作提供资料,对于保障我国转基因产品贸易的顺利进行具有重要意义。     

基因编辑产品检测技术研究进展

当前国内外生物技术产业革命加速推进,以基因编辑为代表的转基因新技术发展迅猛,新基因、新性状、新产品不断涌现。围绕基因编辑产品的检测方法将成为转基因生物安全监管的重要一环和有效支撑。因此,基于测序技术、酶切技术、PCR技术和其他检测技术4个方面,总结了目前应用于基因编辑产品检测的一些技术方法,并对每种方法的优缺点进行了分析,以期为今后基因编辑产品的检测提供思路,做好转基因监管技术储备。     

生物技术软件介绍之二

笔者在《生命科学》1992年第2期上发表的《生物技术软件介绍之一》介绍了6类9个生物技术数据库和软件,包括细胞学数据库、核酸和蛋白质序列数据库和序列分析软件、PCR引物程序等。近一年多来,我们又引进和开发一批新的生物技术软件,其中有些是我们自行设计,有些购自国外,有些通过与国内外学者进行软     

转基因生物的风险管理

正一场突如其来的中美贸易摩擦将转基因大豆推上了风口浪尖。以转基因大豆为代表的农业生物技术产品在摆上百姓的餐桌前,到底经过了怎样的监管,谁来监管,怎么监管,如何确保安全等话题一时间成为国人关注的焦点,吸引了大众目光。全球监管者在行动转基因技术打开了由人类之手操纵微观世界的一扇窗,既能造福人类,也可能带来潜在风险,需要加强管理,防范风险。转基因产品是否安全关键看转入的基因、表达的产物以及转入过程等是否增加风险,这就需要个案分析,     

农业生物技术

美国的农业系统是世界上生产力最高、最有效的系统之一。这部分得益于已往的技术创新。处于生物技术世界领先国家地位所获得的好处,使美国的农业系统面临着独特的机遇和挑战。生物技术为生产一系列新的、高附加值的产品和工具提供了有效而且经济的方法。生物技术在增加食物产量,减少农业对化学农药的依赖,降低原料成本,减少由传统生产方式所带来的环境负效应等方面具有很大的潜力。此外,在分子水平上进行的对生命的性质...     

英国脱欧后基因技术监管趋势及对中国的启示*——基于英国《基因技术报告》的分析

英国脱欧后加快了生物技术领域的立法进程,迫切希望通过革新原先欧盟的保守监管模式,在保障技术安全的前提下充分发挥基因技术的应用价值。为实现该目标,英国发布了《基因技术报告》,旨在重新构建更加全面的基因技术监管体系。这一报告不仅分析了既有基因技术治理实践的不足,还指明了未来英国基因技术监管的方向。当前基因编辑、合成生物学等新型基因技术正处于高速发展时期,英国的报告也为这些技术的应用提供了一条可供参考的治理路径。     

美生物技术产品销售将超过230亿美元

美生物技术产品销售将超过２３０亿美元据一项对生物技术工业的新的分析预测,美国生物技术产品的销售在２００４年将超过２３０亿美元,较互９９４年６０亿美元的基数平均年增长率为１５ｑｏ。生物技术工业６９主要部分包括人用治疗药品（有时称做生物药品）、人用诊断制...     

Assessing weediness of transgenic crops: industry plays plant ecologist

After years of experimentation and limited field testing of genetically modified crop plants, biotechnology companies in many countries are now beginning to commercialize their transgenic products. This development has shifted the focus of public concern to the procedures that governments employ in determining that a particular transgenic crop poses no risk to the environment. In this article we discuss the Information required by the US Animal and Plant Health Inspection Service (APHIS) in making this determination, and compare this with the data that have been called for by ecologists and the data presented by companies in their petitions for nonregulated status.     

Schematic methods for probabilistic enzyme kinetics.

The theory of steady-state enzyme processes which avoids using the mass action law of chemical kinetics and consistently describes catalytic mechanisms by probabilistic concepts has recently been proposed (Mazur, 1991, J. theor. Biol. 148, 229-242). To facilitate the analysis of complex reaction graphs by this theory the possibility of constructing schematic rules similar to those used in classical kinetics is studied. It is found that due to the similarity of algebraic procedures the popular method of King & Altman can be applied in probabilistic kinetics in addition to the earlier proposed rule based on enumeration of cycles of the reaction graph. This similarity also allows one to adapt many other shortcut methods of classical kinetics for probabilistic reaction graphs. The paper considers separately the possibility of transforming reaction mechanisms so that the initial graph is replaced by a simpler but equivalent one. It is shown that there are few cases when a group of states can be replaced by one united state, with earlier known rules such as the rule of Cha for equilibrium stages being particular cases of a more general procedure. In addition a novel method is proposed which performs step-by-step reduction of any reaction graph. All the new methods can be adapted for traditional kinetics as well. The results obtained demonstrate that many schematic rules of classical kinetics are of probabilistic origin.     

White biotechnology: ready to partner and invest in

It needs three factors to build an industry: market demand, product vision and capital. White biotechnology already produces high volume products such as feed additive amino acids and specialty products like enzymes for enantioselective biocatalysis. It serves large and diverse markets in the nutrition, wellness, pharmaceutical, agricultural and chemical industry. The total volume adds up to $ 50 billion worldwide. In spite of its proven track record, white biotechnology so far did not attract as much capital as red and even green biotechnology. However, the latest finance indicators confirm the continuously growing attractiveness of investment opportunities in white biotechnology. This article discusses white biotechnology's position and potential in the finance market and success factors.     

Real time quantitative PCR as a method to evaluate simian virus 40 removal during pharmaceutical protein purification.

Continuous cell lines used for pharmaceutical protein manufacturing have the potential to be contaminated by viruses. To ensure the safety of pharmaceutical proteins derived from continuous cell lines, validation of the ability of the manufacturing process to clear potential contaminating viruses is required for product registration. In this paper, a real time quantitative PCR method has been applied to the evaluation of simian virus 40 (SV40) removal during chromatography and filtration procedures. This method takes advantage of the 5'-3' exonuclease activity of Taq DNA polymerase and utilizes the PRISM 7700 sequence detection system of PE Applied Biosystems for automated SV40 DNA quantification through a dual-labeled fluorogenic probe. This method provides accurate and reproducible quantification of SV40 DNA. The SV40 clearance during chromatography and filtration procedures determined by this method is highly comparable with that determined by the cell-based infectivity assay. This method offers significant advantages over cell-based infectivity assays, such as higher sensitivity, greater reliability, higher sample throughput and lower cost. This method can be potentially used to evaluate the clearance of all model viruses during chromatography and filtration procedures. This method can be used to substitute cell-based infectivity assays for process validation of viral removal procedures and the availability of this method should greatly facilitate and reduce the cost of viral clearance evaluations required for new biologic product development.     

The application of rule-based methods to class prediction problems in genomics.

We propose a method for constructing classifiers using logical combinations of elementary rules. The method is a form of rule-based classification, which has been widely discussed in the literature. In this work we focus specifically on issues that arise in the context of classifying cell samples based on RNA or protein expression measurements. The basic idea is to specify elementary rules that exhibit a locally strong pattern in favor of a single class. Strict admissibility criteria are imposed to produce a manageable universe of elementary rules. Then the elementary rules are combined using a set covering algorithm to form a composite rule that achieves a perfect fit to the training data. The user has explicit control over a parameter that determines the composite rule's level of redundancy and parsimony. This built-in control, along with the simplicity of interpreting the rules, makes the method particularly useful for classification problems in genomics. We demonstrate the new method using several microarray datasets and examine its generalization performance. We also draw comparisons to other machine-learning strategies such as CART, ID3, and C4.5.     

本科生物技术综合性超大实验课程的架构与建设

为了培养本科生的分子生物学实验设计与操作技能,在实践教学中实现培养本科创新人才的目标,以用大肠杆菌发酵生产重组细菌碱性磷酸酶为案例,通过碱性磷酸酶基因的克隆、原核表达、发酵生产、提取纯化以及酶活性检测等系列实验,把本科的基因工程、发酵工程和生物化学3门综合性独立实验课程有机地组合成一个内容相关联的超大型综合性生物技术大实验,进一步凸显了生物技术中以基因工程技术为核心的上游核酸操作、中游发酵生产和下游蛋白分离纯化三大技术模块的有机联系,大大地提高了本科实验教学的综合性和研究性,提升了实践教学水平,取得了良好的教学效果。     

Strategies to enable the adoption of animal biotechnology to sustainably improve global food safety and security

The ability to generate transgenic animals has existed for over 30 years, and from those early days many predicted that the technology would have beneficial applications in agriculture. Numerous transgenic agricultural animals now exist, however to date only one product from a transgenic animal has been approved for the food chain, due in part to cumbersome regulations. Recently, new techniques such as precision breeding have emerged, which enables the introduction of desired traits without the use of transgenes. The rapidly growing human population, environmental degradation, and concerns related to zoonotic and pandemic diseases have increased pressure on the animal agriculture sector to provide a safe, secure and sustainable food supply. There is a clear need to adopt transgenic technologies as well as new methods such as gene editing and precision breeding to meet these challenges and the rising demand for animal products. To achieve this goal, cooperation, education, and communication between multiple stakeholders—including scientists, industry, farmers, governments, trade organizations, NGOs and the public—is necessary. This report is the culmination of concepts first discussed at an OECD sponsored conference and aims to identify the main barriers to the adoption of animal biotechnology, tactics for navigating those barriers, strategies to improve public perception and trust, as well as industry engagement, and actions for governments and trade organizations including the OECD to harmonize regulations and trade agreements. Specifically, the report focuses on animal biotechnologies that are intended to improve breeding and genetics and currently are not routinely used in commercial animal agriculture. We put forward recommendations on how scientists, regulators, and trade organizations can work together to ensure that the potential benefits of animal biotechnology can be realized to meet the future needs of agriculture to feed the world.     

Learning to recognize objects

Several aspects of systems for learning pattern or object recognition rules are discussed. First, how are recognition rules developed and to what extent is structural pattern information embedded into these recognition rules. Second, how are these rules applied to the recognition of complex patterns such as objects embedded in scenes and how is evidence from different rules combined into a single evidence vector. Third, how can learned rules be improved through performance evaluation and feedback to rule generation stages.     

基于DPSEEA模型构建生物安全评价体系：以深圳市为例

由于生物安全内涵外延和基本要素的模糊性、评价指标及评价方法的多元性等因素的限制, 我国至今尚未形成全面有效的生物安全评价指标体系。为构建生物安全评价体系, 研判生物安全现状, 本文首先运用规范分析法剖析《生物安全法》中有关“生物安全”定义的特点及不足, 从国家安全角度认为生物安全是指国家有效防范和应对危险生物因子及相关因素的威胁, 维护和保障自身安全与利益的能力和状态。明晰了生物安全的外延, 即只有对国家安全利益、民众健康、生态环境保护产生威胁的生物风险, 才是生物安全所规制的对象。其次, 生物安全基本要素包括自然生物安全和社会经济生物安全。自然生物安全主要指民众健康和生态环境保护方面, 包括生物个体安全和生物多样性安全。社会经济生物安全的关注点在国家安全利益, 即社会稳定和国家经济利益, 包括生物技术安全、生物实验室安全。第三, 以生物安全基本要素为管理对象的尺度, 将国家安全利益、民众健康和生态环境保护作为评价主体, 以生物法治为理念, 运用模型构建法, 将定性指标和定量指标相结合, 基于驱动力‒压力‒状态‒接触‒影响‒行动模型(driving force-pressure-state-exposure-effect-action, DPSEEA)构建了一套具有生物法治特色的生物安全评价指标体系, 包括生物安全法律法规体系健全水平、生物安全所涉违法犯罪行为的打击力度、生物安全各部门机构协调机制的建立和完善程度、符合规定标准的生物实验室数量和百分比、生物安全人才数量及密度、对生物产业和基本卫生部门的官方援助及其他途径投资总额、疫苗覆盖的目标人群比例、生物安全的宣传教育普及率8项评价指标在内共32项生物安全评价指标。最后, 基于实地调研及数据统计分析, 以2019年和2020年深圳生物安全工作为例对评价体系进行验证。结果显示, 深圳生物安全工作在农业生物安全、动植物防疫、防范外来物种入侵方面成果显著; 但仍在法律法规体系、生物安全人才培养和资金投入、生物安全普及率方面存在不足。针对上述问题提出完善生物安全法律法规体系并注重法律协调衔接、“一个健康”实现多元协同生物治理、加强人才培养和资金投入、加强生物安全宣传教育等建议。