试论制药工程中制药工艺创新技术

作为关系到国计民生的重要领域,医药行业不仅肩负着确保广大人民群众身体健康的责任,同时也承担着病患对其能够减轻其痛苦的期盼。近几年,随着我国医疗水平的不断提升,对药品质量的要求越来越高,同时也更加注重制药工艺创新技术的研发。制药工程的发展对于国家整体医疗水平的提升有着深远的影响,我国制药行业必须致力于制药工艺技术的创新,从而更好地推进制造工程的可持续发展。     

天津大学化工学院制药工程学科与专业

天津大学化工学院是我国化工类学科最齐全、在国内外具有重要影响的学院之一 ,天津大学制药工程学科、专业是在传统优势学科(化学工程、化学工艺、生物化工和精细化工)基础上 ,与生物技术、药学、高分子化工和制药机械等学科交叉 ,成长起来的新兴整合工程学科。天津大学制药工程学科、专业现有工学博士、工学硕士与制药工程领域硕士、工学学士三个层次。本专业面对人才和科技密集型的“常盛、常青”的医药工业产业 ,培养既懂制药工艺 ,又懂工程技术和装备 ,掌握并熟练运用制药工程学科的理论和实践知识 ,解决药物研发与制造过程中的工程技术…     

中国制药装备标准化现状、问题分析与对策

质量提升、标准先行,标准化是促进制药装备行业发展的重要手段。制药装备标准化也是完善中国制药装备体系、规范制药装备市场、升级装备制造水平及提高企业竞争力的关键要素。本文就中国制药装备标准化现状进行综合分析,突出叙述了制药装备标准化在医药工业发展中的重要意义,包括促进药品产业发展、促进制药装备研发创新和技术进步及提升装备企业竞争力,最后剖析了中国制药装备标准化进程存在的问题并提出了相应对策。     

新药研发的趋势及我国制药企业面临的机遇和挑战

制药工业是一个历史悠久的行业,这一传统行业正酝酿着看似细微但却值得关注的变化.这种酝酿可能导致这一行业从研发到生产的彻底改观.这些变化的推动力来源于我们对生命本质和过程的认识,对疾病发生机制的不断揭示,以及现代生物技术的突飞猛进.     

关于《中药制药工程原理与设备》教学改革的研究与思考

《中药制药工程原理与设备》是一门研究制药工程原理及其生产设备的课程,旨在培养学生的中药制药工程原理思想及对中药制药相关设备的认知。为了优化教学效果,更好地适应社会对人才发展的需要,响应国家"中国制造2025引领下的一主体两中心(以学生为主体、以适应生产实际和适应发展为中心)对教学改革和实践的要求",笔者提出了一些思考与建议。     

制剂用压缩空气系统的配置

<正> 随着《药品生产管理规范》的实施,各制药企业都在进行“GMP”改造,纯净压缩空气往往是一个容易被忽视的工程问题,现结合制药企业“GMP”改造工作过程中取得的一些体会,浅谈一下如何获得纯净的压缩空气,供制药行业同仁们参考。     

双螺杆制粒技术及其在药物制剂领域中的应用

双螺杆制粒(twin screw granulation,TSG)是制药行业新兴的一种连续湿法制粒技术,目前在国内制药行业报道较少。本文系统介绍了双螺杆挤出制粒机的结构及工作原理,制剂的处方特点及工艺参数对所得颗粒的形状、粒径、孔隙率等性质的影响,并综述了目前国内外TSG的发展现状以及面临的机遇和挑战。虽然TSG技术仍存在一些问题,但是其独特的工艺过程在连续制造生产模式中显示出巨大的优势和潜力。TSG技术的这些优势将会吸引更多研究者的关注,伴随着过程分析技术的发展,将来可能成为制药行业的一个研究热点。     

日本新药研发现状浅析

日本制药工业协会的《制药协会指南》指出,日本的新药研发能力为全球第3位,仅次于美国和欧洲。本文对日本独立行政法人医药品及医疗器械综合管理机构(PMDA)网站2001―2012年的药品信息数据进行收集、整理,并结合日本制药工业协会及相关企业的新药研发情况进行分析,以加深对日本制药行业发展趋势的了解,为我国的制药行业提供借鉴。     

人工智能在制药行业的应用进展

随着人工智能（AI）技术的高速发展,AI在制药行业展现出广泛的应用潜力。总结AI在药物研发、生产、营销方面的应用情况,分析AI应用在药物靶点发现、分子设计与筛选、药物相互作用预测、生产质量监测、药品鉴别、患者画像、药物推荐等领域的效果与不足。提出应用AI技术赋能制药行业,将在缩短药品研发周期、降低药品生产与供应链成本、降低药物使用安全风险、提高药品推广效率等方面产生巨大价值,为提高药物创新水平以及健康事业带来深远的影响。     

连续结晶在医药工业中的应用

当前制药工业主要为间歇过程，因此将整个制药行业转化为连续生产可以大大提升生产效率、灵活性和产品质量。作为制药工业、中一种重要的单元操作，结晶过程的连续化对整个制药过程有很大影响，本文介绍了制药工业的连续化，连续结晶的研究进展，展望了其应用前景。     

Challenges for the oral delivery of macromolecules

The rapid integration of new technologies by the pharmaceutical industry has resulted in numerous breakthroughs in the discovery, development and manufacturing of pharmaceutical products. In particular, the commercial-scale production of high-purity recombinant proteins has resulted in important additions to treatment options for many large therapeutic areas. In addition to proteins, other macromolecules, such as the animal-derived mucopolysaccharide heparins, have also seen dramatic growth as injectable pharmaceutical products. To date, macromolecules have been limited as therapeutics by the fact that they cannot be orally delivered. This article will address the current status and future possibilities of oral macromolecular drug delivery.     

基于偏离-份额法评价江苏省医药制造业各子产业竞争力

目的:为江苏省医药制造业内部进行产业结构调整提供依据。方法:采用偏离-份额法,分析江苏省医药制造业各子产业的竞争力状况。结果与结论:江苏省医药制造业各子产业的竞争力排序为化学药品制剂制造业、化学药品原料药制造业、中药材及中成药加工业、生物制品业、动物药品制造业。     

Toward the institutionalization of quantum computing in pharmaceutical research

Innovative pharmaceutical companies have started to explore quantum computing (QC). In this article, we provide a collective industry perspective from QC domain leaders at leading pharmaceutical companies. There are immediate nonfinancial benefits in engaging with QC, some likely financial returns in the short term in drug development, manufacturing, and supply chain, and potentially large scientific benefits in drug discovery long term. We discuss the required activities for institutionalizing QC: how to create an understanding of QC among researchers and management, which and how to deploy external resources, and how to identify the problems to be addressed with QC. If (and once) deployable, QC will likely have a similar trajectory to that of computer-aided drug design (CADD) and artificial intelligence (AI) during the 1990s and 2010s, respectively.     

中美药品生产准入法律程序的比较研究

目的:为完善我国药品生产准入法律程序提出建议。方法:通过对中美两国准许设立药品生产企业和准许药品生产及上市销售的法律程序的比较,分析我国现行药品生产准入法律程序存在的缺陷。结果与结论:我国可借鉴美国相关法律的经验,弥补现有的立法缺陷,以企业注册登记程序取代生产许可证审批程序,实施产品《药品生产质量管理规范》(GMP)认证,并将GMP认证程序以及行业发展规划和产业政策的审查程序与药品注册程序相融合。     

The Pharmaceutical Sciences in 2020: Report of a Conference Organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP)

The Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (academicians, scientists, regulators, industrialists, venture capitalists) who shared their views on the forces that might determine how the pharmaceutical sciences will look in 2020. The commentary here provides a summary of major research activities that will drive drug discovery and development, enabling technologies for pharmaceutical sciences, paradigm shifts in drug discovery, development and regulations, and changes in education to meet the demands of academia, industry and regulatory institutions for pharmaceutical sciences in 2020.     

Microdispensing technologies in drug discovery

Because of the advent of managed care,the pharmaceutical industry is entering a new era, characterized by increased competition and pricing pressures. As a result, drug discovery within pharmaceutical companies is rapidly embracing new paradigms to help bring more novel drugs to the market as rapidly as possible. One paradigm currently being pursued is the miniaturization of the processes involved in the exploratory phase of drug discovery. This reduction in scale has led to the development of new dispensing technologies. This review examines several microdispensing technologies for drug discovery.     

Challenges in the pharmaceutical development of lipid-based short interfering ribonucleic acid therapeutics

INTRODUCTION: Harnessing RNA interference as a therapeutic approach has the potential to significantly expand the druggable target space, offering new hope for treatment of diseases that cannot be addressed with existing classes of drugs. A number of siRNA therapeutics have already progressed into preclinical and clinical development. Of these, lipid-based systems have emerged as one of the most mature classes of systemic delivery technologies. Despite tremendous advances in development, a number of significant challenges must still be addressed to enable commercialization of a lipid-based siRNA pharmaceutical product. AREAS COVERED: This review addresses specific challenges inherent to the pharmaceutical development of lipid-based siRNA therapeutics. Focus is placed on the development of a robust manufacturing process, the setting of appropriate product specifications and controls, development of strategies to assess and ensure product stability, and the evaluation of product comparability throughout development. EXPERT OPINION: Discovering and developing a lipid-based siRNA therapeutic that can be commercialized requires engineering a particle that selectively and efficiently delivers the cargo to the target tissue and cellular compartment. The particle assembly must be strictly controlled and physical properties thoroughly characterized to successfully develop an understanding of particle attributes that influence in vivo pharmaceutical properties. Correlation of particle physio-chemical properties to product performance is the foundation for advancements in discovery and assuring quality in a commercial drug product. Although difficult, we believe these development challenges can be addressed with appropriate scientific resources and that the industry will continue to progress siRNA therapeutic candidates through clinical development.     

Human monoclonal antibodies from transgenic mice

Since the 1986 regulatory approval of muromonomab-CD3, a mouse monoclonal antibody (MAb) directed against the T cell CD3epsilon antigen, MAbs have become an increasingly important class of therapeutic compounds in a variety of disease areas ranging from cancer and autoimmune indications to infectious and cardiac diseases. However, the pathway to the present acceptance of therapeutic MAbs within the pharmaceutical industry has not been smooth. A major hurdle for antibody therapeutics has been the inherent immunogenicity of the most readily available MAbs, those derived from rodents. A variety of technologies have been successfully employed to engineer MAbs with reduced immunogenicity. Implementation of these antibody engineering technologies involves in vitro optimization of lead molecules to generate a clinical candidate. An alternative technology, involving the engineering of strains of mice to produce human instead of mouse antibodies, has been emerging and evolving for the past two decades. Now, with the 2006 US regulatory approval of panitumumab, a fully human antibody directed against the epidermal growth factor receptor, transgenic mice expressing human antibody repertoires join chimerization, CDR grafting, and phage display technologies, as a commercially validated antibody drug discovery platform. With dozens of additional transgenic mouse-derived human MAbs now in clinical development, this new drug discovery platform appears to be firmly established within the pharmaceutical industry.     

Optimizing candidate selection--a vision in business limited conference. 1-2 December 1998, Basel, Switzerland

The pharmaceutical industry is faced with filtering hundreds of thousands of compounds to identify successful drug candidates. Given these numbers, how does the pharmaceutical industry identify optimal therapeutic agents rapidly, efficiently, economically and successfully, with the ultimate result of the patient receiving the best drug? The conference summarized the present and future requirements for evaluating emerging technologies, integrating that technology into a filter for large and growing numbers of compounds, building and linking diverse knowledge bases, and establishing predictive foundations that will optimize and accelerate drug discovery and development. Specific conference topics focused on organizational and management approaches as well as some of the major technologies and emerging techniques for supporting drug candidate selection and optimization. It is predicted that the pharmaceutical industry will be synthesizing and screening a million or more compounds for multiple therapeutic targets in the near future. Pulling together the resources of current and emerging technology, knowledge, and multidisciplinary teamwork, so that discovery and selection of successful drug candidates from this large pool of compounds can take place rapidly, is a significant challenge. This conference focused on the organizational issues and experimental tools that can provide for a shortening of discovery time, identification of current and future selection techniques and criteria, the linking of technologies and business strategies to reduce risk, and novel processes for optimizing candidates more quickly and efficiently. The conference was directed at industrial scientists involved in all stages along the drug discovery and development interface. This conference was well-attended, with approximately 100 participants.     

Engineering of pharmaceutical materials: an industrial perspective

Crystal engineering provides a rational approach to solving formulation, processing and product performance problems. This review discusses how the concept of crystal engineering can be judiciously utilized to manipulate the solid-state properties of drugs and excipients for successful pharmaceutical formulation and process development. Existing and emerging manufacturing as well as co-processing technologies being applied in the pharmaceutical industry are also presented together with selected examples of crystal form design, crystal form selection and crystal modifications for illustration purposes.