Tag Archives: Johnson & Johnson

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

AIChE 2010中的PAT–实时监测制粒过程和滚动致密过程

在盐湖城举行的2010 美国化工学会 (AIChE) 年会中,一些出席良好的分会与质量源于设计(QbD) 和工艺过程分析技术(PAT)相关。

美国化工学会年会最近,我在PharmaQbD 博客上以嘉宾身份发表了一个对QbD 和PAT 的简要回顾,题为“如果QbD 是地图,PAT即是GPS”。本博客贴文的出发点是QbD 和PAT以互补的方式来应用是最有效的。在AIChE年会中,可以看到许多好的例子,它们基于将通过QbD实验开发出来的工艺模型应用到后期开发和生产上,在PAT的指导下进行实时监测和控制。

许多讨论关注到药品制造的连续工艺过程,反映了制药生产技术的明显提高。然而,这种提高也同时证实了对(通过QbD)理解工艺过程的需求,以便与工艺过程监测(PAT的一关键要素)相匹配。例如,好几个报告介绍了在滚动致密过程中连续监测颗粒大小的分布,从而提供测量和控制关键质量属性的潜在能力。颗粒(细粒)大小直接影响到粉末的流动性和可压性,通过导致最终制剂的溶出/解体特征的不同进而影响到原料药的生物活性。

如果您对应用工艺过程测量技术来实时理解颗粒和制粒系统感兴趣,我向您建议以下两个免费历届网络研讨会:

PAT at AIChE 2010 – Real-time Monitoring of Granulation and Roller Compaction

At the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting in Salt Lake City, there were a number of well-attended sessions dealing with the related topics of Quality by Design (QbD) and Process Analytical Technologies (PAT). Continue reading

Symposium on Process Safety and Crystallization

On Tuesday, November 2, METTLER TOLEDO held its 1st Symposium in Cambridge, MA, hosted by Novartis Institutes for BioMedical Research (NIBR). The success of the Symposium went beyond expectations: 65 scientists representing a large variety of small companies (CoNCERT, Cubist, Tetraphase), larger companies (Pfizer, Dow, Amgen), and research institutions (Massachusetts Institute of Technology) attended the event. The main themes of the Symposium were crystallization and process safety. Des O’Grady and I started by giving an overview of the technologies later covered by the industry speakers: Focused Beam Reflectance Measurement (FBRM®), Particle Video Microscope (PVM®), EasyMax™, RC1, and ReactIR™. Continue reading

Predicting Dissolution Quality With Fluid Bed Granulation

Last month, Steve Mehrman of Johnson & Johnson gave a presentation on using Fluid Bed Granulation as a predictor of dissolution performanceContinue reading

Predictor of Dissolution Performance in Fluid Bed Granulation

In July, I announced that I would be chairing next week’s In Process Particle Forum  being held in Iselin, NJ.  Today, I want to highlight one of the papers that will be presented at In Process Particle ForumSteve Mehrman of Johnson & Johnson will present on using FBRM C35 during fluid bed granulation development and scale-up.

Continue reading