生物制药新技术分析

生物制药新技术是我国知识经济的重要产物。生物制药产业在我国正处于初级发展阶段。但是,生物制药新技术的应用已经给医疗产业带来的新的发展。生物制药技术属于一种高新技术。进入二十一世纪后,我国政府大力开展生物制药工程的研究和开发。生物制药技术为医疗业和制药业带来了新的发展空间。生物制药技术依托于科学技术的飞速发展。生物制药新技术将成为我国新的经济技术增长点。本文从三方面阐述了生物制药新技术内涵,发展现状和发展前景。     

现代生物制药技术在医药领域中运用分析

伴随着我国社会经济的不断发展,也相应的促进了我国医药行业的发展,多种现代生物制药技术逐渐的应用到医药领域,进而在治疗疾病方面有了显著的发展。因此,本文主要针对于医药领域中现代生物技术的作用进行了相关方面的分析和研究,希望通过本文的探讨,能够进一步促进生物制药技术的良好发展。     

浅析我国海洋生物制药现状及发展策略

我国海洋资源十分丰富,海洋生物制药开发利用前景广阔。该文通过文献研究法列举了我国海洋生物制药产业目前在研发与利用方面所取得的成果,分析了我国当前在海洋生物制药发展存在的问题,提出了从人才、技术、环境等方面进一步发展我国海洋生物制药产业的相关策略。     

生物制药产业的研究现状及趋势

传统化学制药及新化学药品数量在逐年下降,而生物技术药物已成为当今最活跃和发展最迅速的领域。随着生物技术研究的深入,与人、畜疾病发展相关的生物制药产业有着突破性进展。本文从生物制药的概念出发,阐述了抗肿瘤药物、单克隆抗体、仿生药物及孤儿药物的发展现状．对我国生物制药产业的发展趋势进行简要综述,旨在为科研领域及产品开发提供理论参考．推进生物类新药的研制与开发。     

探究我国生物制药产业发展现状以及未来发展趋势

生物制药产业属于新型朝阳产业,其无论对于医药行业的发展,还是对于社会经济的进步来讲,都是至关重要的。探究我国生物制药产业发展现状,深刻理解当前我国生物制药产业发展面临的机遇挑战,并且由此引导生物制药产业朝着更加理想的方向发展,是本文研究的出发点和落脚点。     

三轮驱动，提高企业在国际市场的竞争力

生物技术是21世纪高新技术的核心之一,它对传统制药业及其他相关产业的发展产生若深刻影响。生物技术产业是21世纪的支柱产业之一,生物制药产业是生物技术产业中发展最快、成果最多、潜力最大的领域。我国的生物制药产业经过了20多年的发展,现状如何、在国际生物医药产业中的地位怎样,近日,我们带着业界人士对我国生物制药产业的关注采访了中国生物技术集团公司副总经理曾兵先生。[编者按]     

论生物制药领域国际化背景下我国药企的应对策略

生物制药产业是发展迅速的高新技术产业之一。生物制药产业的全球化发展,对我国生物制药企业既是挑战也是机遇,我们应予以高度重视。本文介绍了全球生物制药的发展动态,分析了我国生物制药产业的现状和存在的问题,最后,提出了应对策略。     

生物制药过程中存在的管理问题及对策探究

近年来,随着现代化社会经济水平的不断加快,制药产业不断快速发展,生物制药产业也日益进步发展。生物技术的快速开发研究给生物制药带来了较大的发展机遇,生物制药过程实际上就是将生物工程技术科学合理的应用到制药管理领域的过程。但是现阶段我国的生物制药管理工作还不成熟,经常在实际管理工作中出现诸多问题,本文就生物制药过程中存在的管理问题进行论述,并提出合理化建议对策。     

生物制药技术及其产业的发展情况

随着科学技术的快速发展,生物制药行业在近几年也得到了极大的发展,生物制药技术不断提高,生物制药产业也越来越受到广泛的关注。本文主要结合实际经验来探讨目前生物制药技术产业所具有的特点,生物制药产业中目前现存技术的存在问题。通过探讨存在的问题更好的促进我国生物制药产业的发展。     

浅谈我国生物制药产业的现状和发展趋势

本文讲述了我国生物制药产业的目前形势,阐明了我国生物制药产业存在的问题和国外企业的差距逐渐拉大,指出了今后我国生物技术制药的发展方向,并且规划了我国生物制药产业的行业前景。     

Current status and perspectives of biopharmaceutical drugs

Since the first approval of recombinant human insulin three decades ago, more than 150 biopharmaceutical drugs have been marketed, and some of them became blockbuster drugs in market size. The patent expiration of the oldest biopharmaceutical drugs resulted in the development of biosimilar drugs. However the short serum half-life of biopharmaceutical drugs incurs a frequent injection to maintain a target clinical outcome in patients. The other major critical concern of biopharmaceutical drugs is immunogenicity producing anti-drug antibodies. These antibodies may reduce clinical efficacy by neutralizing biological activity, and may not only cause a severe allergic reaction but also other serious adverse reactions by blocking endogenous proteins. In order to improve pharmaceutical properties and reduce immunogenicity, the next generation biobetter drugs were achieved by glycoengineering technology, pegylation technology and protein engineering technology. Other biobetter drugs having optimized binding sites were also generated by in vitro display technology. Many of those biobetter drugs have been developed and/or are under development, and come into the clinical field in the near future.     

生物技术药物的研究开发与产业化现状及前景

本综述了近年来国内外生物技术药物的研究、开发和产业化现状,讨论了我国医药生物技术产业存在的主要问题。提出中国医药生物技术产业发展应遵循自主开发与技术引进相结合及政府引导与市场机制相结合的原则,政府、企业和科技界应发挥各自不同的作用;展望了我国生物药物产业的发展方向和生物技术药物的市场前景。     

无细胞合成生物学：革新生物医药产业的新策略

无细胞合成生物系统,能够在体外完成生命转录翻译过程,因体系灵活开放、便于控制、表达周期短、高耐受性等特点,可表达细胞系统难以表达的蛋白质。随着无细胞生物传感和体系冻干技术的不断发展,其在医药健康领域的应用不断拓展。本文综述了无细胞合成生物学在按需生物医药合成和便携式医疗检测等医药健康领域的研究进展,该体系的进一步发展有潜力实现更复杂后修饰蛋白质药物的合成、可丰富无细胞生物传感器类型并提高其灵敏性。无细胞合成生物学作为新兴工程策略,未来必将更好地应用于高通量医药蛋白质筛选、新型病原体的检测等医药健康领域。     

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.     

重组单克隆抗体电荷异质性和工艺调控

重组单克隆抗体药物大多存在翻译后修饰且种类复杂多样,因此研发过程中的质量控制显得尤为重要。其中电荷异质性是关键质量属性,其可能影响生物制品的疗效,甚至有可能带来意想不到的副作用,从而影响药品的安全性和有效性,所以在单抗药物开发过程中需要重点关注并加以调控。单抗药物翻译后修饰是造成电荷异质性的主要原因,因此电荷异质性的控制是生物药物工艺开发的一个重要挑战。梳理了电荷异质性的表征方法,并且根据其分类对能够造成电荷异质性产生的蛋白翻译后修饰进行了总结,同时阐述了不同的电荷异质性对抗体类药物安全性及有效性的影响,最后总结了工艺开发中电荷异质性工艺调控策略的最新进展,以期给生物药物工艺开发及质量研究人员以启示。     

Anything but Conventional Chromatography Approaches in Bioseparation

While packed bed chromatography, known as conventional chromatography, has been serving the biopharmaceutical industry for decades as the bioseparation method of choice, alternative approaches are likely to take an increasing leading role in the next few years. The high number of new biological drugs under development, and the need to make biopharmaceuticals widely accessible, has been driving the academia and industry in the quest of anything but conventional chromatography approaches. In this perspective paper, these alternative approaches are discussed in view of current and future challenges in the downstream processing field.     

微针用于生物大分子及纳米药物透皮给药的尝试与挑战

生物大分子及纳米药物,比如,亚单位疫苗、DNA疫苗、以及针对真皮层的治疗药物,作为近年来新兴的治疗药物,在有些治疗领域有着透皮给药的需求。由于具有靶向性高,疗效显著等特点,生物大分子及纳米药物逐渐成为新的研究热点。微针作为一种新型的给药技术,不仅具有无痛、给药方便等优点,而且运用物理手段可大幅提高大分子甚至纳米药物的透皮吸收及皮层靶向,能够避过胃肠道消化作用以及肝脏首过效用。将微针技术与生物大分子药物相结合,能够同时发挥两者的优势,实现高靶向生物药物的无痛给药。本文简述微针透皮给药技术、以及生物大分子给药的研究进展,对微针技术用于生物大分子及纳米药物透皮给药的尝试研究做了介绍和总结,对存在的技术挑战进行了分析和展望。     

Development and application of a GFP-FRET intracellular caspase assay for drug screening

Apoptosis is a crucial biological process, and activation of caspase endoproteases is essential for proper regulation and execution of apoptosis. Because caspases also appear to be central players in several pathological states, there is a practical need within the biopharmaceutical research community for facile, noninvasive cellular assays for the discovery of compounds that modulate caspase activity. Tandem molecules of green fluorescent protein (GFP) stably expressed within cells can serve as a genetically encoded sensor of protease activity. Using this technology, we have developed a stable cellular system for the screening of agents that modulate activation of the caspase cascade. This assay technology allows for the real-time monitoring of apoptosis in situ, using conventional fluorescent plate reader detection. By applying this assay system to an actual compound screen, small-molecule inducers of cell apoptosis were reliably identified. Follow-up pharmacology confirmed that the rank-order potency of primary hits using the intracellular GFP assay corresponded to that found using a conventional, cell lysis-based assay method.     

Incentives for biodefense countermeasure development

Therapeutics and vaccines are available for only a fraction of biological threats, leaving populations vulnerable to attacks involving biological weapons. Existing U.S. policies to accelerate commercial development of biodefense products have thus far induced insufficient investment by the biopharmaceutical industry. In this article, we examine the technical, regulatory, and market risks associated with countermeasure development and review existing and proposed federal incentives to increase industrial investment. We conclude with several recommendations. To increase industry's engagement in biodefense countermeasure development, Congress should expand BioShield funding, giving HHS the flexibility to fund a portfolio of biodefense countermeasures whose revenues are comparable to those of commercial drugs. Congress should establish tradable priority review vouchers for developers of new countermeasures. A National Academy of Sciences or National Biodefense Science Board should formally evaluate incentive programs and a government-managed "Virtual Pharma," in which HHS contracts separate stages of research, development, and production to individual firms.     

Biopharmaceutical liquid formulation: a review of the science of protein stability and solubility in aqueous environments

Formulation scientists employed in the biopharmaceutical industry face the challenge of creating liquid aqueous formulations for proteins that never had evolutionary pressure to be exceptionally stable or soluble. Yet commercial products usually need a shelf life of 2 years to be economically viable. The research done in this field is dominated by physical chemists who have developed theories like preferential interaction, preferential hydration and excluded volume to explain the mechanisms for the interaction between salt, small organic molecules and proteins. This review aims to translate the research findings on protein stability and solubility produced by the physical chemists and make it accessible to formulation scientists working within the biopharmaceutical industry.