Tag Archives: GlaxoSmithKline

第一届年度RSC/SCI连续流动学术报告会

Jon Goode、Nigel Gaunt和我参加了第一届年度皇家化学学会(RSC)/化学工业学会(SCI)的连续流动学术报告会,该会于十一月初在英国由地处Stevenage的GlaxoSmithKline公司主持。考虑是第一次举办这种特殊报告会,其出席状况非常良好。这也提示我们大家对连续流动的兴趣越来越高。

监测连续流动化学在此学术报告会上,我展示了一个墙报,题为“配备ReactIR™ (FTIR) 测量的连续化学过程”。我讨论了对产品质量、产率、合成途径、安全、和总体时间效率上的改进如何已成为科学家和工程师们寻找化学开发的非传统方法的动力因素。

要确保只生产想要的产物,反应控制很关键,而像带毒性和/或高活性中间体这些副产物可能难以控制进而带给操作人员安全危险。连续流动反应器能使化学反应得到更好的控制,降低生成非理想产物的可能性,并因操作体积很小而显著降低对操作人员的安全危险。

对连续流动反应器进行理想的控制自然需要在线分析技术。离线分析方法只能零散地对控制参数提供反馈(数分钟或数小时的间隔,根据所用分析技术/方法),而在线测量仪每几秒到几分钟提供一反馈。我讨论了为什么与微型流动池相结合的傅立叶变换红外(FTIR)光谱的应用提供一个理想的在线测量装置,用它来对反应的控制参数进行监测和控制反馈,从而达到即时理解和优化其工艺过程。

我的报告用了两个不同的例子(还原反应和羰基化作用)表明连续流动反应器与在线ReactIR™测量技术相结合的应用价值。从这两个例子中搜集的信息演示了这种结合体系的有效性。

如果您有兴趣了解更多有关流动化学的益处,我邀请您参看英国剑桥大学Steven Ley 教授的在线报告:将ReactIR流动池应用于连续工艺过程技术 或者我最近制作的一个短视频:什么是流动化学?

2010 Fall Meeting Highlights

Now that the busy fall meeting season has come to an end, I wanted to take the opportunity to quickly revisit some highlights that my colleagues and I noted: Continue reading

1st Annual RSC/SCI Continuous Flow Symposium

Jon Goode, Nigel Gaunt, and I attended the 1st Annual Royal Society of Chemistry (RSC)/Society of Chemical Industry (SCI) Continuous Flow Symposium held last week at GlaxoSmithKline in Stevenage, United Kingdom.  Considering that this was the first time this particular event was held, it was very well attended.  This was yet another reminder of what seems to be an ever increasing interest in continuous flow. Continue reading

怎样实时跟踪颗粒分布:AAPS 2010

2010 美国医药科学家协会(AAPS) 年会 即将于十一月十四至十八日在新奥尔良召开。本届AAPS年会与国际医药联邦(FIP)的医药科学国际协会 (PSWC)携手,将聚集来自全世界的数千医药科学家们。在此,我想点出会议上将要讨论的一些涉及怎样实时跟踪颗粒分布的报告:http://cn.mt.com/cn/zh/home/events/fairs/AAPS_2010.html?=US_AC_eAdv_zhBlog

  • SU9199  用非谱图式在线颗粒分布的确定作为高剪切力湿式成粒的终点;Purdue University, Sunday PM
  • T2124  评价用于高剪切力湿式成粒监测和终点确定的PAT 工具:NIR, FBRM, PVM, ARS Novartis, Tuesday AM
  • T2139  工艺过程分析技术:用FBRMPVM 在线监测PLGA 微米颗粒形成过程;FDA/CDER/OPS/DPQR, Tuesday AM
  • T3070 用高分子来维持溶解差的药物分子在液添胶囊制剂试管溶解时的超饱和机理研究;Amgen, Tuesday PM
  • W4256 实时颗粒分析:用聚光反射测量 (FBRM) 作为工艺过程分析技术 (PAT) Campbell University and GlaxoSmithKline, Wednesday AM
  • W5050  预测高剪切力湿式研磨药物固体的表现; Pfizer, Wednesday PM
  • W5423  质量源于设计 (QbD) 案例研究:寻找实时PAT工艺过程监测与离线产品定性分析之间的关联;FDA/CDER/OPS/DPQR, Wednesday PM
  • W5429  Lasentec FBRM C35 探头用于高剪切力湿式成粒过程中实时测量颗粒玄长分布的分辨率和灵敏度以及与其它颗粒分布技术的对比; Bristol-Myers Squibb (BMS), Wednesday PM
  • W5432  通过原位颗粒和液滴定性分析改进液体制剂; METTLER TOLEDO, Wednesday PM
  • R6266  应用QbD原理评价各种Hypromellose等级以确保可持续放行的制剂工艺;GlaxoSmithKline, Thursday AM

我期待在AAPS年会上见到您,并邀请您参观展示大厅的612展台。

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How To Track Particle Distribution in Real Time: AAPS 2010

The 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting will be held November 14 to 18 in New Orleans.  As thousands of pharmaceutical scientists from around the world prepare to gather for the AAPS conference that is being held in conjunction with the International Pharmaceutical Federation’s (FIP) Pharmaceutical Sciences World Congress (PSWC), I wanted to highlight some papers that will discuss how to track particle distribution in real-time:

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In Process Particle Forum: Liquid and Solid Dosage Formulations

I am excited to be chairing the upcoming In Process Particle Forum focused on Liquid and Solid Dosage Formulations on September 15 in Woodbridge, NJ. This will be the third year in a row that METTLER TOLEDO has brought together expert users of FBRM and PVM to present their cutting edge research to a group of their peers. This year, we have the best agenda yet with four industry papers from:

  • Bristol-Myers Squibb
  • Merck
  • Johnson and Johnson
  • GlaxoSmithKline

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World Congress on Particle Technology 6: FBRM and PVM real-time particle system characterization at WCPT6 in Nuremburg, Germany (26-29 April, 2010)

POWTECH-WCPT6-Nuremburg-METTLER-TOLEDO-FBRM-C35The particle size distribution is a critical parameter in process efficiency and product quality in many pharmaceutical, chemical and industrial processes. The real-time measurement of particle count, dimension and shape of particles as they actually exist in process provides critical process information that speeds up process understanding and enables a better means of real-time measurement and control.

At next week’s World Congress on Particle Technology in Nuremburg, two of my colleagues will be presenting papers covering research and case studies covering a variety of applications of real-time measurement of particle systems using on-line particle characterization tools.

The titles of the four papers that will be presented are listed below :

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Optimization and Scale-up of High Shear Wet Granulation Processes

GlaxoSmithKline-GSK-granulation-measurement-FBRM-C35

FBRM® C35 with mechanical wiper for in situ granulation measurement

One goal of high shear granulation is to yield repeatable endpoint granule size, shape, and density distributions. This is necessary for consistent downstream flow properties, tablet consistency, and content uniformity. Quality by Design (QbD) is a concept applied to gain true process understanding through tools such as Design of Experiment (DoE), risk management, and Process Analytical Technology (PAT).

This extended abstract summarizes collaborative research between GlaxoSmithKline (GSK) and METTLER TOLEDO in the application of process analytical technologies (PAT) to the monitoring, optimization and control of High Shear Wet Granulation.

Download the extended abstract for this upcoming conference presentation.

Authors:
Zane Arp, GSK
Eric Dycus, Ben Smith, METTLER TOLEDO
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