Tag Archives: Bristol-Myers Squibb

IFPAC 2011上谈PAT与颗粒大小分析

2010工艺过程中的颗粒论坛会上的三位报告者将在2011年1月21日于(美国)马里兰州的巴尔的摩举行的IFPAC (工艺过程分析技术国际论坛)上作报告。Johnson & Johnson的Steve Mehrman和Merck & Co. 的James Butz被排在周五上午的“颗粒特征分析超声光谱”IFPAC 的第五分会作报告。Bristol-Myers Squibb的Kevin Macias将在周五上午的“药品开发与生产的控制战略”第七分会中作报告。 Continue reading

PAT & Particle Size Analysis at IFPAC 2011

Three speakers from the 2010 In-Process Particle Forum will present at IFPAC [International Forum Process Analytical Technology] on January 21, 2011 in Baltimore, MD.  Steve Mehrman  of Johnson & Johnson and James Butz of Merck & Co. are scheduled to present during the Particle Characterization/Analysis-Ultrasound Spectroscopy Friday AM V session at IFPAC.  Kevin Macias of Bristol-Myers Squibb will present during the Control Strategies for Drug Product Development and Manufacturing Friday AM VII session. Continue reading

2010 AAPS 年会–特讯

上周我参加了在新奥尔良召开的2010 美国医药科学家协会(AAPS) 年会。这次AAPS会议将平行进行的技术报告和墙报分会于一大型贸易展会结合在一起。

粒径分布测量在医药制剂中的应用在这2010 AAPS会议上,热门议题有质量源于设计(QbD)、工艺过程分析技术(PAT)、以及趋向于药品实时放行的动力。FBRM和PVM技术得到很多壁报和报告的良好描述,主要反映它们在药品制剂过程中理解、优化、和控制颗粒大小分布上的应用。

两个注目的壁报来自Novartis和Bristol-Myers Squibb,集中介绍了FBRM C35在高剪切力湿式成粒过程中的应用。Novartis的文章–“评价用于高剪切力湿式成粒过程的监测和终点检定的PAT工具:NIR、FBRM、PVM、ARS” – 概述了一个用FBRM跟踪颗粒增长和细颗粒消失的研究案例。作者的结论:“FBRM对细颗粒群的灵敏性使变异的根源得到理解并得以消除。Bristol-Myers Squibb的文章–“用于高剪切力湿式成粒过程中实时测量玄长分布的FBRM C35 探头的分辨率和灵敏性、以及与其它粒径分布技术的关联”–显示了在一个干混和过程中FBRM怎样对不同级别的MCC之间的区别提供了充分的灵敏度,同时所得FBRM 数据是怎样与离线粒径测量技术良好关联的。BMS还介绍了描述FBRM数据的创新方法,即把玄长分布的变化视觉化为一个随时间变化的热图。

其它感兴趣的AAPS壁报有:

  • “工艺过程分析技术:用FBRM和PVM在线监测PLGA微粒形成过程” – 美国食品药品管理局 (FDA)
  • “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特征分析之间的关联” – 美国食品药品管理局(FDA)
  • “将QbD原理应用在为可持续性放行对各种级别的Hypromellose进行评价上” – GlaxoSmithKline
  • “预测制药固体在高剪切力研磨过程中的表现” – Pfizer
  • “用高分子来维持一个难溶药物分子的液充胶囊制剂在体外溶出超饱和的一个机理研究” – Amgen Inc.

从个人角度,我有幸被接受作一个壁报,集中介绍FBRM和PVM在改进液体制剂上的应用,像悬浮液、乳状液、和离散液。该壁报–“用原位颗粒和液滴特征分析改进液体制剂”–回顾了这个领域里近来的工作,包括FBRM如何能跟踪湿磨终点、改进乳化过程的放大、以及在变化的温度和搅拌条件下筛选悬浮稳定性条件。没能参加今年AAPS的人可在网上找到我壁报的内容- 请求即得网络研讨会:用在线颗粒和液滴测量来使液体制剂过程得以控制

新奥尔良为AAPS 大会提供了完美的背景,我幸运地得知了Creole与Cajun美食之间的区别!谁有兴趣的话,我喜欢Creole!

2010 AAPS Annual Meeting – Highlights

American Association of Pharmaceutical Scientists (AAPS) MeetingThis week, I was in New Orleans attending the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. The AAPS Meeting combines a large trade show with technical presentation and poster sessions running in parallel.

At the 2010 AAPS meeting, hot topics included Quality by Design (QbD), Process Analytical Technology (PAT) and the drive towards real-time release for pharmaceutical products. FBRM and PVM technologies were well represented with numerous posters and presentations focusing on their use to understand, optimize and control particle size distribution during drug product formulation. Continue reading

AIChE 2010 年会 — 结晶过程

从阅读即将召开的2010 美国化工学会年会的技术内容中, 我注意到以下数篇涉及结晶工艺过程工作的人员会感兴趣的报告:http://cn.mt.com/cn/zh/home/events/fairs/AiChE-2010.html?=US_AC_eAdv_zhBlog

  • 包括工艺放大的用于Drown-out 结晶过程的工艺模拟手段, Eleftherios Kougoulos – Pfizer
  • 用PAT (工艺过程分析技术)定性分析快速结晶工艺过程, Barbara Wood – University College Dublin
  • 结晶工艺自动化平台: 集成硬件、软件、和PAT来促进结晶工艺过程的开发, Amanda Rogers – Bristol-Myers Squibb
  • 应用PAT来定义设计空间从而实现结晶工艺过程的控制战略, George Zhou – Merck & Co.
  • 在一个工业化半釜式糖结晶釜中实时监测晶体成核和增长速率, Terry Redman – METTLER TOLEDO
  • 结合工艺过程分析技术的结晶过程放大–确保从R&D 实验室到生产厂的成功, Terry Redman – METTLER TOLEDO
  • PAT在设计和优化塞流结晶系统中的应用, University College Dublin
  • 在2,6-Diamino-3,5-Dinitropyrazine-1-Oxide (LLM-105) 重结晶中应用原位技术, Andrew G. Pearsall – Naval Surface Warfare Center
  • 建立一个从起始晶种分布预测过饱和度和晶体大小的结晶过程模型的成功与挑战, James Vernille – Bristol-Myers Squibb

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Crystallization at the AIChE 2010 Annual Meeting

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Symposium on Green Processing in the Pharmaceutical & Fine Chemical Industries

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Association for Crystallization Technology 17th Larson Workshop

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Optimization and Scale-up of Fluid Bed Processes

Fluid Bed Granulation and Coating from GEA and Niro Pharma SystemsSpray layering is increasingly being used to produce spherical pellets of a target particle distribution – often with engineered dissolution profiles for time-release formulations.

This extended abstract summarizes collaborative research between GEA (Niro) Pharma Systems and METTLER TOLEDO in the application of process analytical technologies (PAT) to the monitoring, optimization and control of Precision Fluid Bed Granulation and Fluid Bed Coating.

Download the extended abstract from the presentation given at the 7th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology.

Authors:
Andrew Birkmire, Dr. Kim Walters, GEA (Niro) Pharma
Dr. Mario Hubert, BMS
Eric Dycus, Terry Redman, Ben Smith, METTLER TOLEDO
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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

Continue reading