Tag Archives: QbD

Quality by Design

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



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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Green Pharmaceutical Manufacturing on a Foundation of PAT & QbD

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com.

Next week, METTLER TOLEDO is hosting a webcast on using Process Analytical Technology (PAT) and Quality by Design (QbD) for the greening of drug manufacturing operations. I’ll be kicking off the program by discussing the potential of the industry to leverage PAT/QbD to meet corporate sustainability objectives such as reducing energy usage and cutting carbon emissions. It’ll be a big-picture look at the elements of PAT and QbD that overlap with sustainable manufacturing. Continue reading

Use of Process Analytical Technology (PAT) for Biotech

Process Analytical Technology (PAT) for Biotech: A Review of Recently Reported Applications in Fermentation and BioProcessing

Fermentation and bioprocessing play critical roles in the discovery and manufacture of new pharmaceuticals and specialty chemicals, and in the sustainable production of bulk fuels and commodity chemicals. Yet fermentation processes are often operated with a minimal level of monitoring and control, limiting the ability to optimize yields and production rates. Continue reading


在过去的五年里, FDA和ICH质量倡导在药品研发与生产行业开启了一个跳跃性转变。在第十七届工艺过程开发国际会议上,Christine Moore作了一个关于FDA对药品开发行业质量源于设计(QbD)的观点的报告。在她的报告中, Christine谈到美国食品药品管理局(FDA)相信质量源于设计提供的各种优势,包括: Continue reading


不论您是致力于绿色化学与化工的研发及应用,还是关注或实施PAT与QbD理念在制药领域的应用,您都可能会受益于2010年11月3日(星期三)举行的网络研讨会—–题为“在PAT与QbD的基础上建立绿色药品制造”。Pharmaceutical Manufacturing 杂志资深编辑 Paul Thomas 将概述工艺过程分析技术 (PAT) 体系和绿色制造行动计划是如何在追求制药业研究与制造效率过程中彼此互补和强化的。他将用不同的现实案例来说明PAT与绿色理念的应用是如何在开发与操作可持续性制造工艺中互助互利的。 Continue reading

Quality by Design (QbD) at the BioProcess International Conference

Last week, I had the opportunity to attend the BioProcess International Conference in Providence, RI. Many of the sessions I attended highlighted the advancement of the Bio-Pharmaceutical industry in applying the principles of Quality by Design (QbD). Continue reading

Going Green: Fall Events for the Pharmaceutical and Chemical Industries

During the fall, a number of events related to green chemistry, green engineering, and other sustainability topics for the pharmaceutical and chemical industries are planned.  Some notable green events are:

Process Analytical Technology (PAT) & Laboratory Automation Developments in the Pharmaceutical & Chemical Industries

Dominique Hebrault will present the online seminar New Developments in the Use of PAT and Laboratory Automation from the Pharmaceutical and Chemical Industries on September 15.  Specific case studies that Dominique will discuss include: Continue reading

Is Quality by Design (QbD) Stuck, Struggling, or Just Slow to Mature?

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com. He can be reached at pthomas@putman.net, and followed on Twitter @PaulThomasPharm.

There has been a lot of discussion within pharmaceutical circles of late as to what’s ailing the Quality by Design (QbD) movement. There are those who say that nothing is. There have been some “striking success stories on how Quality by Design can reduce defects and variability,” noted FDA CDER’s Janet Woodcock at the DIA annual meeting in June. QbD is “a success story that is evolving,” she added.
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