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Bioprocessing最新文献

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Rapid and Effective Monitoring of Baculovirus Concentrations in Bioprocess Fluid Using the ViroCyt® Virus Counter® 使用ViroCyt®病毒计数器®快速有效地监测生物工艺液中杆状病毒浓度
Pub Date : 2014-07-10 DOI: 10.12665/J132.KEMP
C. Kemp, April Birch, Heather E. Allen, Kerrie Kennefick, A. Gugel
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引用次数: 2
Identification of Worst-Case Model Viruses for Selected Viral Clearance Steps 选定病毒清除步骤的最坏情况模型病毒识别
Pub Date : 2014-07-10 DOI: 10.12665/J132.Nims
R. Nims, M. Plavsic
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引用次数: 3
Optimising Vaccine Process Scale-Up of Attachment-Dependent Cells Using Micro Bioreactors and Microcarriers 利用微生物反应器和微载体优化贴附依赖性细胞的疫苗生产工艺
Pub Date : 2014-07-10 DOI: 10.12665/J132.ZORO
B. Zoro
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引用次数: 0
Using Quality by Design (QbD) to Build Effective Product and Process Control Strategies Based on a Well-Structured Design Space 基于结构良好的设计空间,利用设计质量(QbD)建立有效的产品和过程控制策略
Pub Date : 2014-07-10 DOI: 10.12665/J132.Witcher
Mark Witcher
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引用次数: 0
Connection Technology Advances Closed System Processing: Single-Use Connectors Create Improved Flexibility and Reliability, and Drive Cost Savings for Biopharmaceutical Manufacturers 连接技术推进封闭系统处理:一次性使用连接器提高了灵活性和可靠性,并为生物制药制造商节省了成本
Pub Date : 2014-04-24 DOI: 10.12665/J131.Boehm
J. Boehm
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引用次数: 0
Risk Assessment of Residual Genomic DNA in Therapeutic Proteins Using Gene Copy Number Application 基因拷贝数应用于治疗性蛋白中残留基因组DNA的风险评估
Pub Date : 2014-04-24 DOI: 10.12665/J131.FADNIS
R. Fadnis, Reena Nr, R. Soni
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引用次数: 1
Biobanking Operations: Contingency Planning and Disaster Recovery of Research Samples 生物银行操作:研究样本的应急计划和灾难恢复
Pub Date : 2014-04-24 DOI: 10.12665/J131.HAGER
R. Hager
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引用次数: 5
Fetal Bovine Serum: What You Should Ask Your Supplier and Why 胎牛血清:你应该问你的供应商什么和为什么
Pub Date : 2014-04-24 DOI: 10.12665/J131.DAVISHIRSCHI
Devin W. Davis, S. Hirschi
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引用次数: 5
Continuous Bioprocessing and Perfusion: Wider Adoption Coming as Bioprocessing Matures 连续生物处理和灌注:随着生物处理技术的成熟,应用越来越广泛
Pub Date : 2014-04-24 DOI: 10.12665/J131.LANGER
E. Langer
B atch processing has long been the predominant bioprocessing paradigm, both upand downstream. Bioprocessing f luids are processed incrementally, piped as a bolus or transferred via vessels from one process and piece of equipment to the next. This continues to work well, including a number of technological advances resulting in improvements that continue to make bioprocessing more efficient. Upstream and overall process yields are essentially doubling about every five years, with this largely driven by improved cell lines, expression systems and genetic engineering, culture media, and equipment. Among the technologies now gaining increasing adoption and market share for biopharmaceutical manufacture is continuous (bio) processing, with perfusion currently the leading technology, in terms of adoption. The use of incremental, one-step-at-a-time, classic batch processing in biopharmaceutical manufacture is different than most other major products manufacturing and high-tech industries, where processing is generally more continuous. In this context, the move toward more continuous processing in manufacturing is a common characteristic of industries starting to reach maturity. Continuous processing is exemplified by assembly lines, and petroleum refining with processing involving a rather continuous flow of the material being manufactured from one unit operation to the next. Continuous processing generally follows and eventually replaces incremental manufacturing. Continuous processing generally requires more process knowledge, equipment and technological advances than incremental manufacturing. Successful adoption of continuous processing by any industry requires each of the component processes involved to be more integrated, at least with the next process. Continuous processing requires a sufficient critical mass of technological competencies and available equipment capable of supporting process integration. For example, implementing continuous bioprocessing, such as upstream perfusion, is not practical if the next and following steps are unable to handle this output. This article reviews and details some of the key advances and trends in the bioprocessing industry that have emerged which are creating greater adoption and potential for continuous processing as the industry matures. We evaluate aspects of continuous processing, exemplified by perfusion, and the adoption of these technologies by the biopharmaceutical manufacturing (bioprocessing) industry.
长期以来,生物加工一直是主要的生物加工模式,无论是上游还是下游。生物处理液是逐步处理的,作为丸剂通过管道输送或通过容器从一个过程和设备转移到下一个过程和设备。这种做法一直很有效,包括一些技术进步带来的改进,继续使生物处理更有效。上游和整个过程的产量基本上每五年翻一番,这在很大程度上是由改进的细胞系、表达系统和基因工程、培养基和设备推动的。在生物制药制造中,目前越来越多地采用和占有市场份额的技术是连续(生物)加工,灌注是目前采用的领先技术。生物制药生产中使用增量式、一步一步的经典批量加工与大多数其他主要产品制造和高科技行业不同,后者的加工通常更连续。在这种情况下,制造业向更连续的加工方向发展是开始走向成熟的行业的共同特征。连续加工的例子是装配线和石油炼制,其加工涉及到从一个单元操作到下一个单元操作的材料的相当连续的流动。连续加工通常遵循并最终取代增量制造。与增量制造相比,连续加工通常需要更多的工艺知识、设备和技术进步。任何行业成功地采用连续加工都要求所涉及的每个组件过程更加集成,至少与下一个过程集成。连续加工需要足够的临界质量的技术能力和能够支持工艺集成的可用设备。例如,实施连续的生物处理,如上游灌注,是不现实的,如果下一个和后续步骤无法处理这个输出。本文回顾并详细介绍了生物加工行业中出现的一些关键进展和趋势,随着行业的成熟,这些进展和趋势正在为连续加工创造更大的采用和潜力。我们评估了连续加工的各个方面,例如灌注,以及生物制药制造(生物加工)行业对这些技术的采用。
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引用次数: 38
Physicochemical and Biological Evaluation of Bioadhesive Polymers for the Development of Intranasal Low Sialic Acid Erythropoietin Formulations 用于鼻内低唾液酸促红细胞生成素制剂的生物黏附聚合物的理化和生物学评价
Pub Date : 2014-04-24 DOI: 10.12665/J131.AMARO-GONZALEZ
D. Amaro-González, A. Muñoz-Cernada, J. Cardentey-Fernández, Z. Pardo-Ruíz, D. Díaz-Sánchez, V. Montero-Alejo, I. Sosa-Testé, M. Fernández-Cervera, J. García-Rodríguez
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引用次数: 1
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Bioprocessing
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