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。     

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。     

生物法处理生物制药废水

生物制药废水具有化学需氧量高、悬浮物高、硫酸盐和蛋白质含量高等特点,随着国家对环保排放标准和要求的不断提高,能否对生物制药废水进行有效的处理已经成为制药企业能否顺利发展的重要因素。本文就生物法处理生物制药废水进行了综述,希望对生物制药企业污水处理工作有一定的指导意义。     

浅析我国生物制药产业的发展现状与未来发展趋势

生物制药是指运用微生物学,生物学,医学,生物化学等学科的知识,以天然生物材料为原材料,凭借对应的生物制药技术而制造出来能够运用于预防,治疗和诊断的制品。生物制药产业作为国民经济的重要组成部分,关系到人民群众的生命健康和生活质量,是应该得到扶持的。文章从这个角度出发,对于我国生物制药产业的发展现状进行探究,并且预测未来我国生物制药产业的发展趋势。     

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。     

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。     

默克密理博——优化中国生物制药环境

迈入上海浦东的张江高科技园区,随手拦下辆出租车,司机都会知道默克密理博的位置。占地2500平方米的默克密理博生物制药技术培训中心,名声显赫不仅因其园区优美、设备专业;更因为其知名的服务与市场,它将为中国市场的生物制药客户提供从技术支持、培训、验证等全方位的技术支持和解决方案。尤为重要的是,它致力于创新并优化生物制药环境,支持着中国生物制药行业的崛起     

生物制药中物料质量的控制要点及策略研究

在生物制药过程中，使用的原料和材料会影响产品最终的质量、安全性和有效性。良好的物料质量可以确保生物制药产品的一致性和稳定性。而质量较差的原料可能会对产品的纯度和效力产生负面影响。为了确保生物制药产品的高质量，制药公司需要采取严格的质量控制措施来检查和验证原料的质量。因此文章对生物制药中物料质量的控制要点展开分析，并提出相应的策略，以期为相关制药工作提供学术参考和帮助。     

我国生物制药研究进展及展望

比较全面的介绍我国生物制药研究的进展,讨论我国在生物制药研究中存在的问题,一定程度的提出解决办法以及展望。通过大量调研相关文献资料,对近几年我国在生物制药研究上的成果进行总结。综合利用各个相关学科的研究成果、不断研发新技术是我国的生物制药研究取得长足进步的关键。     

Biopartitioning micellar separation methods: modelling drug absorption

The search for new pharmacologically active compounds in drug discovery programmes often neglects biopharmaceutical properties as drug absorption. As a result, poor biopharmaceutical characteristics constitute a major reason for the low success rate for candidates in clinical development. Since the cost of drug development is many times larger than the cost of drug discovery, predictive methodologies aiding the selection of bioavailable drug candidates are of profound significance. This paper has been focussed on recent developments and applications of chromatographic systems, particularly those systems based on amphiphilic structures, in the frame of alternative approaches for estimating the transport properties of new drugs. The aim of this review is to take a critical look at the separations methods proposed for describing and predicting drug passive permeability across gastrointestinal tract and the skin.     

Recombinant plant-derived pharmaceutical proteins: current technical and economic bottlenecks

Molecular pharming is a cost-effective platform for the production of recombinant proteins in plants. Although the biopharmaceutical industry still relies on a small number of standardized fermentation-based technologies for the production of recombinant proteins there is now a greater awareness of the advantages of molecular pharming particularly in niche markets. Here we discuss some of the technical, economic and regulatory barriers that constrain the clinical development and commercialization of plant-derived pharmaceutical proteins. We also discuss strategies to increase productivity and product quality/homogeneity. The advantages of whole plants should be welcomed by the industry because this will help to reduce the cost of goods and therefore expand the biopharmaceutical market into untapped sectors.     

重组蛋白在中国仓鼠卵巢细胞中高效表达的影响因素

高效表达重组蛋白 ,对于生物制药意义重大。大多数药用蛋白是糖蛋白 ,中国仓鼠卵巢细胞 (Chinesehamsterovarycell,CHO)是目前重组糖基蛋白生产的首选体系。影响外源蛋白在CHO细胞中表达的因素很多 ,从CHO细胞表达体系、表达载体系统、外源基因、表达细胞株的加压扩增与筛选、细胞大规模培养等方面对CHO高效表达加以阐述 ,同时提出存在的问题和未来的发展方向。     

Decision-support tool for assessing biomanufacturing strategies under uncertainty: stainless steel versus disposable equipment for clinical trial material preparation

This paper presents the application of a decision-support tool, SIMBIOPHARMA, for assessing different manufacturing strategies under uncertainty for the production of biopharmaceuticals. SIMBIOPHARMA captures both the technical and business aspects of biopharmaceutical manufacture within a single tool that permits manufacturing alternatives to be evaluated in terms of cost, time, yield, project throughput, resource utilization, and risk. Its use for risk analysis is demonstrated through a hypothetical case study that uses the Monte Carlo simulation technique to imitate the randomness inherent in manufacturing subject to technical and market uncertainties. The case study addresses whether start-up companies should invest in a stainless steel pilot plant or use disposable equipment for the production of early phase clinical trial material. The effects of fluctuating product demands and titers on the performance of a biopharmaceutical company manufacturing clinical trial material are analyzed. The analysis highlights the impact of different manufacturing options on the range in possible outcomes for the project throughput and cost of goods and the likelihood that these metrics exceed a critical threshold. The simulation studies highlight the benefits of incorporating uncertainties when evaluating manufacturing strategies. Methods of presenting and analyzing information generated by the simulations are suggested. These are used to help determine the ranking of alternatives under different scenarios. The example illustrates the benefits to companies of using such a tool to improve management of their R&D portfolios so as to control the cost of goods.     

Multiobjective long-term planning of biopharmaceutical manufacturing facilities

Biopharmaceutical companies with large portfolios of clinical and commercial products typically need to allocate production across several multiproduct facilities, including third party contract manufacturers. This poses several capacity planning challenges which are further complicated by the need to satisfy different stakeholders often with conflicting objectives. This work addresses the question of how a biopharmaceutical manufacturer can make better long-term capacity planning decisions given multiple strategic criteria such as cost, risk, customer service level, and capacity utilization targets. A long-term planning model that allows for multiple facilities and accounts for multiple objectives via goal programming is developed. An industrial case study based on a large scale biopharmaceutical manufacturer is used to illustrate the functionality of the model. A single objective model is used to identify how best to use existing capacity so as to maximize profits for different demand scenarios. Mitigating risk due to unforeseen circumstances by including a dual facility constraint is shown to be a reasonable strategy at base case demand levels but unacceptable if demands are 150% higher than expected. The capacity analysis identifies where existing capacity fails to meet demands given the constraints. A multiobjective model is used to demonstrate how key performance measures change given different decision making policies where different weights are assigned to cost, customer service level, and utilization targets. The analysis demonstrates that a high profit can still be achieved while meeting key targets more closely. The sensitivity of the optimal solution to different limits on the targets is illustrated.     

Medium term planning of biopharmaceutical manufacture using mathematical programming

Regulatory pressures and capacity constraints are forcing the biopharmaceutical industry to consider employing multiproduct manufacturing facilities running on a campaign basis. The need for such flexible and cost-effective manufacture poses a significant challenge for planning and scheduling. This paper reviews the problem of planning and scheduling of biopharmaceutical manufacture and presents a methodology for the planning of multiproduct biopharmaceutical manufacturing facilities. The problem is formulated as a mixed integer linear program (MILP) to represent the relevant decisions required within the planning process and is tested on two typical biopharmaceutical industry planning problems. The proposed formulation is compared with an industrial rule based approach, which it outperforms in terms of profitability. The results indicate that the developed formulation offers an effective representation of the planning problem and would be a useful decision tool for manufacturers in the biopharmaceutical industry particularly at times of limited manufacturing capacity.     

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。     

无细胞蛋白表达体系研究进展及在生物制药领域中的应用

作为一种快速高效的体外蛋白合成手段,无细胞蛋白表达体系(Cell-free Protein Synthesis,CFPS)一直以来就被广泛应用于基础生物学领域的研究。与传统的基于细胞的体内表达体系相比,CFPS突破了细胞的生理限制,其可调控性强、对毒性蛋白的耐受力高,使得许多很难在体内合成的复杂蛋白在体外顺利表达。近年来随着研究人员不断对CFPS进行优化,通过简化制备工艺、开发价格低廉的能量再生系统、稳定底物供应、促进蛋白正确折叠等方式,成功研发出生产效率高、成本低廉、反应体积大的表达体系。凭借其高通量和大规模的蛋白表达优势,CFPS为解决生物制药领域中面临的难题提供了新的解决思路,并成功地应用于高通量药物筛选、大规模生产重组蛋白药物、个体化定制肿瘤疫苗等领域,显示出其在生物制药领域的重要应用潜力。     

Enhanced virus removal by flocculation and microfiltration

In this work we have investigated the feasibility of virus clearance by flocculation and tangential flow microfiltration. Chinese hamster ovary cell feed streams were spiked with minute virus of mice and then flocculated using cationic polyelectrolytes prior to tangential flow microfiltration. Our results indicate that flocculation prior to microfiltration leads to more than 100 fold clearance of minute virus of mice particles in the permeate. Today, validation of virus clearance is a major concern in the manufacture of biopharmaceutical products. Frequently new unit operations are added simply to validate virus clearance thus increasing the manufacturing cost. The results obtained here suggest that virus clearance can be obtained during tangential flow microfiltration. Since tangential flow microfiltration is frequently used for bioreactor harvesting this could be a low cost method to validate virus clearance.     

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。