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Manufacturing of viral vectors for gene therapy: part I. Upstream processing 基因治疗用病毒载体的制造:第一部分:上游加工
Pub Date : 2014-06-04 DOI: 10.4155/PBP.14.16
O. Merten, M. Schweizer, P. Chahal, A. Kamen
Manufacturing technologies for the production of clinical grade viral vectors have been significantly improved in recent years. This is of utmost importance for gene therapy approaches used in the treatment of inherited or acquired diseases. This article briefly describes the general principles for the production of viral vectors. The specific sections are dedicated to more detailed descriptions of the production of adenoviral, AAV, γ-retroviral and lentiviral vectors. A subsequent article (the second part) will then deal with downstream processing (purification) of viral vectors.
近年来,用于生产临床级病毒载体的制造技术有了显著改善。这对于用于治疗遗传或获得性疾病的基因治疗方法至关重要。本文简要介绍了生产病毒载体的一般原则。具体部分致力于更详细地描述腺病毒、AAV、γ-逆转录病毒和慢病毒载体的生产。随后的文章(第二部分)将处理病毒载体的下游处理(纯化)。
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引用次数: 33
Recombinant protein and mAb biopharmaceuticals to become a commodity 重组蛋白和单抗生物制药成为商品
Pub Date : 2014-06-04 DOI: 10.4155/PBP.14.11
E. V. Corven
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引用次数: 0
In situ microscopy and MIR-spectroscopy as non-invasive optical sensors for cell cultivation process monitoring 原位显微镜和mir -光谱学作为非侵入性光学传感器用于细胞培养过程监测
Pub Date : 2014-06-04 DOI: 10.4155/PBP.14.13
Christian Lüder, P. Lindner, David Bulnes‐Abundis, Shaobin Lu, Tim H. Lücking, D. Solle, T. Scheper
Background: The use of modern sensors for online monitoring has become increasingly important in biotechnology. For bioprocess analysis the chemical and physical environment as well as the biological component itself must be monitored in detail and in real-time. Results: Modern non-invasive optical sensors allow reliable predictions of the current process status just in time. Two sensors, one for the biologic and one for monitoring the chemical system of a CHO cell cultivation process, are presented. With an in situ microscope, cell count and morphology are monitored, to assess the efficiency of the cell growth up to a cell concentration of 1.4·107 cells/ml. An infrared sensor was used to analyze glucose concentration profiles. Both sensors can be used as in situ non-invasive sensors. Conclusion: With both sensors, reliable online monitoring of CHO cell cultivation process is feasible that react immediately to changes in process conditions. Higher product quality and more efficient processes can be realized.
背景:利用现代传感器进行在线监测在生物技术中变得越来越重要。为了进行生物过程分析,必须对化学和物理环境以及生物成分本身进行详细和实时的监测。结果:现代非侵入式光学传感器可以及时可靠地预测当前工艺状态。介绍了两种传感器,一种用于生物传感器,另一种用于监测CHO细胞培养过程的化学系统。在原位显微镜下,监测细胞计数和形态,评估细胞生长效率,直至细胞浓度为1.4·107个细胞/ml。红外传感器用于分析葡萄糖浓度谱。这两种传感器都可以用作原位非侵入式传感器。结论:利用这两种传感器,对CHO细胞培养过程进行可靠的在线监测是可行的,可以对工艺条件的变化做出即时反应。可以实现更高的产品质量和更高效的工艺。
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引用次数: 19
Antifoams: the overlooked additive? 消泡剂:被忽视的添加剂?
Pub Date : 2014-06-04 DOI: 10.4155/PBP.14.5
S. Routledge, D. Poyner, R. Bill
Present research has found that antifoams can have a broad range of effects upon bioprocesses, both on the culture environment and upon the cells themselves.
目前的研究发现,抗泡沫剂可以对生物过程产生广泛的影响,无论是对培养环境还是对细胞本身。
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引用次数: 10
The role of microbiology in the design and development of pharmaceutical manufacturing processes 微生物学在制药工艺设计和开发中的作用
Pub Date : 2014-06-04 DOI: 10.4155/PBP.14.6
A. Lolas
The role of microbiologists in pharmaceutical development and manufacturing has become more visible in recent years due to the QbD and risk-based approaches promoted by regulatory authorities and industry [1]. Microbiology, microbiological control and contamination control are indispensable in the manufacture of sterile and nonsterile products as well as biologic drug substances, as evidenced by multiple conference presentations and publications. Terms such as objectionable microorganisms, organisms of concern, alert and action limits, environmental monitoring and sterility are dominating our daily work. Lack of sterility assurance is the number one reason for recalls of sterile drug products, and presence of objectionable organisms is the number one reason for recalls of nonsterile products [2,3]. While no one disputes the role of microbiologists in the design and development of pharmaceutical manufacturing processes, microbiologists still appear ‘confined’ in the laboratory of the manufacturing facility long after a process has been established and approved. They are not visible as equal partners in the development process along with chemists and pharmacists. However, microbiology issues frequently arise and critical decisions must be made. The science of microbiology and its applications have a large impact on microbiological and contamination-control strategies for robust and consistent processes with infrequent failures and contaminations. End-product testing is no longer considered acceptable for assuring product quality. Back to the basics When expectations and practices seem to drift away from science and reach scientifically unjustifiable terrain, we need to go ‘back to the basics’ and the science of applied microbiology. This is even more necessary when regulatory expectations impose scientifically insupportable requirements and expectations. Training and mentoring microbiologists in the basic principles of microbiology is critical. Microorganisms do not visit facilities out of nowhere; there is a source associated with their origin and introduction into a facility and manufacturing process. Once introduced, favorable conditions are required for a microorganism’s growth. Such conditions must be evaluated to understand whether this microorganism could represent a hazard to the product and patient. Microbiological control centers primarily on preventing the introduction of microorganisms into a manufacturing process. If introduction cannot prevented, then control is achieved by destruction, removal, inhibition of microorganisms, or a combination of these approaches. Drug product sterility is based on destruction or removal of microorganisms and is indicated for products that bypass the human body’s natural defenses (e.g., parenteral administration). In the case of nonsterile products, APIs, excipients and biologic drug substances, small amounts of microorganisms are acceptable provided that they do not replicate in the final material duri
微生物学家在药物开发和制造中的作用近年来变得更加明显,这是由于监管当局和行业bbb推动的QbD和基于风险的方法。微生物学、微生物控制和污染控制在无菌和非无菌产品以及生物原料药的生产中是必不可少的,这在多次会议和出版物中得到了证明。诸如不良微生物、值得关注的有机体、警戒和行动限制、环境监测和无菌等术语主导着我们的日常工作。缺乏无菌保证是召回无菌药品的首要原因,而存在不良微生物是召回非无菌产品的首要原因[2,3]。虽然没有人质疑微生物学家在制药工艺设计和开发中的作用,但在一个工艺已经建立和批准很久之后,微生物学家似乎仍然“局限”在生产设施的实验室里。在发展过程中,他们不像化学家和药剂师那样是平等的伙伴。然而,微生物学问题经常出现,必须做出关键的决定。微生物学及其应用对微生物学和污染控制策略有很大的影响,这些策略可以实现健壮和一致的过程,并且很少发生故障和污染。最终产品测试不再被认为是可接受的,以确保产品质量。当期望和实践似乎偏离了科学,达到了科学上不合理的领域时,我们需要“回到基础”和应用微生物学。当监管期望强加科学上无法支持的要求和期望时,这就更有必要了。对微生物学家进行微生物学基本原理的培训和指导是至关重要的。微生物不会无缘无故造访设施;有一个与它们的起源和引入设备和制造过程相关的来源。一旦引入,微生物的生长就需要有利的条件。必须对这些条件进行评估,以了解该微生物是否可能对产品和患者构成危害。微生物控制主要集中在防止微生物进入生产过程。如果无法阻止传入,则通过破坏、清除、抑制微生物或这些方法的结合来实现控制。药品无菌是基于微生物的破坏或去除,适用于绕过人体自然防御的产品(例如,肠外给药)。在非无菌产品、原料药、赋形剂和生物原料药的情况下,少量的微生物是可以接受的,前提是它们在储存过程中不会在最终材料中复制,并且这些微生物是非致病性的,不会产生其他不良条件。非无菌药物药学评论
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引用次数: 4
Biopharmaceutical protein production by Saccharomyces cerevisiae: current state and future prospects 酿酒酵母生产生物制药蛋白的现状与展望
Pub Date : 2014-06-04 DOI: 10.4155/PBP.14.8
Mingtao Huang, Jichen Bao, J. Nielsen
In the past few decades there has been an increasing demand of biopharmaceutical proteins in the market. Several types of cell factories are applied to produce different pharmaceutical proteins. However, manufacturers prefer to use a few favorable biological platforms to undertake the production tasks with low cost, high productivity and proper post-translational modifications. The yeast Saccharomyces cerevisiae is one of these preferred cell factories as it meets many of the requirements. There are several reports on improvement of recombinant protein production by S. cerevisiae through rational engineering of different stages of the protein secretion pathway. However, recent developments of new technologies like systems biology and synthetic biology open new doors to design S. cerevisiae as an ideal production platform.
在过去的几十年里,市场上对生物制药蛋白质的需求不断增加。几种类型的细胞工厂被用于生产不同的药用蛋白。然而,制造商更愿意使用一些有利的生物平台来承担低成本、高生产率和适当的翻译后修饰的生产任务。酿酒酵母是这些首选的细胞工厂之一,因为它满足许多要求。有几篇报道称,酿酒酵母通过对其蛋白分泌途径的不同阶段进行合理的工程改造,提高了重组蛋白的产量。然而,近年来系统生物学和合成生物学等新技术的发展为设计酿酒葡萄球菌作为理想的生产平台打开了新的大门。
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引用次数: 45
Qualification of a differential scanning calorimetry method for biophysical characterization of monoclonal antibodies and protein vaccine antigens 鉴定单克隆抗体和蛋白质疫苗抗原生物物理特性的差示扫描量热法
Pub Date : 2014-05-30 DOI: 10.4155/PBP.14.27
M. Kirkitadze, Jian Hu, Mei Tang, B. Carpick
Background: Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Methodology The focus of this study was the qualification of a differential scanning calorimetry method that is used to examine thermal stability and tertiary structure of protein vaccine antigens and monoclonal antibody products. The analytical parameter evaluated was precision, through assessment of the characteristics of repeatability and intermediate precision. Conclusion: The results demonstrated that the assay met the desired performance characteristics, and is suitable...
背景:分析方法确认包括对验证特征子集的简化评估,目的是证明分析方法是科学合理的,适合其预期用途。与验证相反,分析方法的确认是在没有预定义的可接受标准的情况下进行的。确认可以作为方法验证的先决条件,或者当产品知识分析尚未建立为关键产品质量属性的测试时。本研究的重点是鉴别用于检测蛋白质疫苗抗原和单克隆抗体产物的热稳定性和三级结构的差示扫描量热法。通过对可重复性和中间精密度特性的评价,评价了分析参数的精密度。结论:该方法符合要求的性能指标,适用于不同类型的药材。
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引用次数: 4
Standard operating procedures revisited: a 2014 perspective 重新审视标准操作程序:2014年视角
Pub Date : 2014-02-01 DOI: 10.4155/pbp.14.1
A. Kanarek
Approximately 50 years after the good manufacturing practice (GMP) regulations were first issued, regulatory inspections of firms operating under GMP are still uncovering cases of non-compliance with the rules concerning written operating procedures and the need to follow them. These rules are fundamental to GMP and are simple to understand. Future changes to GMP will emphasize risk management and the need to have an effective quality culture in the firm. SOPs will still form an essential part of the quality system. This article examines the principal problem areas in standard operating procedure management and provides recommendations for correcting them.
在良好生产规范(GMP)法规首次发布大约50年后,对在GMP下运营的公司的监管检查仍然发现不遵守书面操作程序规则的情况,并需要遵守这些规则。这些规则是GMP的基础,很容易理解。未来对GMP的修改将强调风险管理和在公司中建立有效质量文化的必要性。标准操作程序仍将是质量体系的重要组成部分。本文探讨了标准操作程序管理中的主要问题,并提出了纠正这些问题的建议。
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引用次数: 0
Interview: Pharmaceutical microbiology 访谈:药物微生物学
Pub Date : 2014-01-31 DOI: 10.4155/PBP.13.64
Tim Sandle
Tim Sandle is Head of Microbiology at Bio Products Laboratory (Hertfordshire, UK). In addition, he is a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester (Manchester, UK) where he teaches the University’s pharmaceutical microbiology MSc course. Sandle serves on several national and international committees including the microbiology society Pharmig (Hertfordshire, UK). Sandle has written almost three hundred book chapters, peer-reviewed papers and technical articles relating to microbiology, as well as being the author or co-editor of eight books. Sandle runs a microbiology discussion site, Pharmaceutical Microbiology. Sandle spoke to Pharmaceutical Bioprocessing for the first in a series of interviews on pharmaceutical microbiology. Interview conducted by Jessica Thorne, Assistant Commissioning Editor.
Tim Sandle是生物制品实验室(英国赫特福德郡)微生物学负责人。此外,他还是曼彻斯特大学(Manchester, UK)药学院的客座导师,教授该大学的药物微生物学硕士课程。桑德尔服务于几个国家和国际委员会,包括微生物学会药学(赫特福德郡,英国)。Sandle撰写了近300篇与微生物学相关的书籍章节、同行评议的论文和技术文章,同时还是八本书的作者或共同编辑。桑德尔经营着一个微生物学讨论网站——药物微生物学。桑德尔在一系列关于药物微生物学的采访中首次向制药生物加工公司发表了讲话。采访由杰西卡·索恩,助理委托编辑。
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引用次数: 1
Are automated disposable small-scale reactors set to dominate the future of pharmaceutical bioprocess development? 自动化一次性小型反应器是否将主导制药生物工艺发展的未来?
Pub Date : 2014-01-31 DOI: 10.4155/PBP.13.62
D. Pollard
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引用次数: 7
期刊
Pharmaceutical bioprocessing
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