医药生物技术研究与产业化进展

当今世界上许多国家特别是发达国家都把发展生物技术及其产业作为提高本国科技和经济竞争力的重要手段。医药生物技术是生物技术首先取得突破,实现产业化的技术领域,世纪之交的医药生物技术呈现出蓬勃发展态势,美国在医药生物技术领域占据了世界领先地位,各种生物技术产品被广泛应用于医疗,制药等行业,医药生物技术已成为美国高技术产业发展的核心动力之一,近年来,我国的医药生物技术研发和产业化取得了长足的进展,在基因的定位和克隆,体细胞克隆,遗传病的基因诊断技术,基因治疗,肿瘤免疫治疗,抗血管治疗,组织工程,干细胞的研究等方面均取得了可喜成果,逐步缩短了先进国家的差距,本文综述了近年来医药生物技术的领域的研究,开发和产业化现状,并对加速我国医药生物技术及其产业的发展提出了一些建议。     

医药生物技术研究与产业化进展

当今世界上许多国家特别是发达国家都把发展生物技术及其产业作为提高本国科技和经济竞争力的重要手段。医药生物技术是生物技术首先取得突破 ,实现产业化的技术领域 ,世纪之交的医药生物技术呈现出蓬勃发展态势。美国在医药生物技术领域占据了世界领先地位 ,各种生物技术产品被广泛应用于医疗、制药等行业 ,医药生物技术已成为美国高技术产业发展的核心动力之一。近年来 ,我国的医药生物技术研发和产业化取得了长足的进展 ,在基因工程药物和疫苗、单抗导向药物、人工血液代用品、生物芯片的研制 ,疾病相关基因的定位和克隆、体细胞克隆、遗传病的基因诊断技术、基因治疗、肿瘤免疫治疗、抗血管治疗、组织工程、干细胞的研究等方面均取得了可喜成果 ,逐步缩短了与先进国家的差距。本文综述了近年来医药生物技术领域的研究、开发和产业化现状 ,并对加速我国医药生物技术及其产业的发展提出了一些建议。     

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。     

我国农业生物技术及其产业化发展现状与前景

目前中国农业生物技术研究的某些领域已处于国际领先水平,现代农业的发展迫切需要农业生物技术的支撑,农业生物技术产业化发展已是大势所趋.综述了中国农业生物技术研究及其产业发展的现状,在此基础上提出了相关发展对策与建议,并对未来农业生物技术及其产业的发展前景进行分析与展望.     

生物技术药品的产业化

生物技术产业将成为２１世纪的主导产业之一,当前美国的生物技术产业化在全球居领先地位,生物技术药品产业化前景十分光明。我国生物技术药品开始实现产业化,已批准５种药品投放市场,只有十多种产品进入中试开发阶段。本文对我国生物技术药品产业化现状进行了分析,对加快产业化速度提出了意见。     

我国生物技术产业化的症结与出路

本文提示有关过程开发的关键问题、特定步骤以及主要条件，并强调其为生物技术产业化进程中的必由之路，再举例介绍国外小生物技术公司进行基础研究然后与大药厂联合开发、投产上市的方式，指了同我国解决生物技术产业化问题的一条可行的出路。     

生物技术药品的产业化

生物技术产业将成为２１世纪的主导产业之一,当前美国的生物技术产业化在全球居领先地位,生物技术药品产业化前景十分光明。我国生物技术药品开始实现产业化,已批准５种药品投放市场,只有十多种产品进入中试开发阶段。本文对我国生物技术药品产业化现状进行了分析,对加快产业化速度提出了意见。     

2001年度NSFC资助的医药生物技术与生物技术药物研究项目简析

总结了2001年度获得国家自然科学基金资助的医药生物技术与生物技术药物领域项目的基本情况,分析了其主要研究方向、特点,提出加强医药生物技术与生物技术药物基础研究的建议。     

生物技术药物产业化发展的新趋势

自从人类基因组计划完成以来 ,结构基因组、功能基因组、蛋白质组等研究计划相继启动 ,这为生物技术的发展注入了强大的活力。各国对此十分重视 ,并把生物技术产业的发展作为国家经济发展中新的增长点之一。美国生物技术药物产业化最早 ,投资最大 ,产品数量最多。由于ＦＤＡ新领导人致力于改革 ,加快了审批速度 ,2 0 0 3年批准的生物技术药物数量创历年来新高 ,达 37个 (图 1 )。其中 2 5个新药 ,比2 0 0 2年增加了 2 5 % ,另外....     

转基因动物在生物制药工业中的应用

简要论述了转基因动物的概念、制作方法及应用领域,回顾了转基因动物技术的发展及现状,分析了转基因动物与克隆动物的区别.就转基因动物在制药工业和生物医药领域中的国内外研究与开发应用情况进行了阐述,同时展望了转基因动物制药的发展前景及对社会的影响.     

技能大赛背景下高职生物制药技术综合实训课程教学改革

综合实训是高职学生将理论知识与生产实践有机融合的重要教学环节。本文介绍了技能大赛背景下,学院生物制药技术专业立足“以赛促教、以赛促建、以赛促学、育训结合”特色,以青霉素发酵工艺实验为例,从教学目标、教学内容、教学方法、考核等内容进行的改革与实践,将发酵设备的实践操作与虚拟仿真软件相融合,双向交互式开展课程。突破发酵过程控制的主观依赖性,建立发酵过程参数控制的量化管理和评价,更有利于实现技能大赛与实践教学的高效融合。通过近几年的改革与实践,取得良好的教学效果,为同类课程基于技能大赛的教学实践改革提供了新的思路和借鉴。     

Dispersal and inhibition of biofilms associated with infections

As bacteria aggregate and form biofilms on surfaces in the human body such as tissues, indwelling medical devices, dressings and implants, they can cause a significant health risk. Bacterial biofilms possess altered phenotypes: physical features that facilitate antibiotic resistance and evasion of the host immune response. Since metabolic and physical factors contribute to biofilm maturation and persistence, an objective in antibiofilm therapy is to target these factors to deliver innovative approaches for solving these important health problems. Currently, there is little research on the direct immunological effects resulting from the introduction of foreign components to the body pertaining to biofilm inhibition methods. Detailed research involving animal models is necessary to better understand the biological side effects of synthetic peptides, genetically modified bacteriophages and isolated proteins and any resistance that may develop from these approaches.     

The pandemic and resilience for the future: AccBio 2021

The year 2020 brought the onslaught of a global crisis in the form of the COVID-19 pandemic. While nearly every facet of everyday life and work was impacted by the pandemic, the biopharmaceutical industry found silver linings in innovation, partnership, and resiliency, all of which contributed to unprecedented speed in developing and delivering vaccines and therapies. The 7th International Conference on Accelerating Biopharmaceutical Development (AccBio 2021) brought together industry leaders to share experiences from the past year and discuss how lessons learned from the pandemic can be carried forward into the future of biopharmaceutical development. Presenters highlighted examples such as introducing biotherapeutics derived from non-clonal cell pools into the clinic, developing modular or platform technologies, and taking novel risks, among others. These strategies for enabling speed to clinic and launch, as well as for sustaining a robust supply chain, are likely to be integrated into future programs to ensure biomanufacturing resiliency and get medicines to patients faster than pre-pandemic times.     

Applications of microbial co-cultures in polyketides production

Polyketides are a large group of natural biomolecules that are normally produced by bacteria, fungi and plants. These molecules have clinical importance due to their anti-cancer, anti-microbial, anti-oxidant and anti-inflammatory properties. Polyketides are biosynthesized from units of acyl-CoA by different polyketide synthases (PKSs), which display wide diversity of functional domains and mechanisms of action between fungi and bacteria. Co-culture of different micro-organisms can produce novel products distinctive from those produced during single cultures. This study compared the new polyketides produced in such co-culture systems and discusses aspects of the cultivation systems, product structures and identification techniques. Current results indicate that the formation of new polyketides may be the result of activation of previously silent PKSs genes induced during co-culture. This review indicated a potential way to produce pure therapeutic polyketides by microbial fermentation and a potential way to develop functional foods and agricultural products using co-co-culture of different micro-organisms. It also pointed out a new perspective for studies on the process of functional foods, especially those involving multiple micro-organisms.     

Comparative development of knowledge-based bioeconomy in the European Union and Turkey

Abstract

Biotechnology, defined as the technological application that uses biological systems and living organisms, or their derivatives, to create or modify diverse products or processes, is widely used for healthcare, agricultural and environmental applications. The continuity in industrial applications of biotechnology enables the rise and development of the bioeconomy concept. Bioeconomy, including all applications of biotechnology, is defined as translation of knowledge received from life sciences into new, sustainable, environment friendly and competitive products. With the advanced research and eco-efficient processes in the scope of bioeconomy, more healthy and sustainable life is promised. Knowledge-based bioeconomy with its economic, social and environmental potential has already been brought to the research agendas of European Union (EU) countries. The aim of this study is to summarize the development of knowledge-based bioeconomy in EU countries and to evaluate Turkey’s current situation compared to them. EU-funded biotechnology research projects under FP6 and FP7 and nationally-funded biotechnology projects under The Scientific and Technological Research Council of Turkey (TUBITAK) Academic Research Funding Program Directorate (ARDEB) and Technology and Innovation Funding Programs Directorate (TEYDEB) were examined. In the context of this study, the main research areas and subfields which have been funded, the budget spent and the number of projects funded since 2003 both nationally and EU-wide and the gaps and overlapping topics were analyzed. In consideration of the results, detailed suggestions for Turkey have been proposed. The research results are expected to be used as a roadmap for coordinating the stakeholders of bioeconomy and integrating Turkish Research Areas into European Research Areas.     

生物信息学的研究现状及其发展问题的探讨

结合生物信息学产生的历史条件,对生物信息学的定义进行了介绍;归纳总结了现代生物信息表述、采集、储存、传递、检索的表现形式-生物学数据库的分类与分布;着重介绍了生物信息学的主要研究内容和基本的分析方法,阐明了生物信息的分析和解读模式;强调了生物信息学与其他相关学科的相关性,提出了生物信息学发展的一些亟待解决的问题及其相应的解决方案。     

Ectopic expression of human mTOR increases viability, robustness, cell size, proliferation, and antibody production of chinese hamster ovary cells

Engineering of mammalian production cell lines to improve titer and quality of biopharmaceuticals is a top priority of the biopharmaceutical manufacturing industry providing protein therapeutics to patients worldwide. While many engineering strategies have been successful in the past decade they were often based on the over‐expression of a single transgene and therefore limited to addressing a single bottleneck in the cell's production capacity. We provide evidence that ectopic expression of the global metabolic sensor and processing protein mammalian target of rapamycin (mTOR), simultaneously improves key bioprocess‐relevant characteristics of Chinese hamster ovary (CHO) cell‐derived production cell lines such as cell growth (increased cell size and protein content), proliferation (increased cell‐cycle progression), viability (decreased apoptosis), robustness (decreased sensitivity to sub‐optimal growth factor and oxygen supplies) and specific productivity of secreted human glycoproteins. Cultivation of mTOR‐transgenic CHO‐derived cell lines engineered for secretion of a therapeutic IgG resulted in antibody titers of up to 50 pg/cell/day, which represents a four‐fold increase compared to the parental production cell line. mTOR‐based engineering of mammalian production cell lines may therefore have a promising future in biopharmaceutical manufacturing of human therapeutic proteins. Biotechnol. Bioeng. 2011; 108:853–866. © 2010 Wiley Periodicals, Inc.     

生物芯片研发现状及展望

生物芯片技术作为新一代生物技术,已引起国际国内广泛关注及重视,在许多领域将得到越来越广泛的应用,本文就生物芯片的类型,研发状况及其应用作简要介绍。     

国外动物生物技术研究和产业化趋势分析

生物技术在全世界范围取得了飞速的进展,与此同时其应用和产业化在各国政府、科研机构和生物技术公司的大力参与和激烈竞争中也逐步加快,预计它将成为许多国家经济的重要支柱产业之一。一些重大生物研究项目如人类基因组计划、克隆技术等开始引起公众的广泛注意。综述了２０世纪９０ 来动物生物技术的发展状况,对基因组研究、转基因动物、克隆技术和细胞培养等重要研究方向作了介绍和分析。