Tag Archives: Pfizer

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

While reviewing the technical program for the upcoming 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting, I noticed several papers of interest to those of us who work in crystallization: Continue reading

Symposium on Green Processing in the Pharmaceutical & Fine Chemical Industries

Last week, John Tedesco and I had the privilege to attend the 3rd International Symposium on Green Processing in the Pharmaceutical & Fine Chemical Industries in Boston, MA. Continue reading

How Pfizer Is Improving Process Development For Bench Scientists

Recently, Dr. Marty Guinn, Director of Chemical Development for Pharma Therapeutics at Pfizer, wrote: Continue reading

Early Phase Implementation of Process Analytical Technology (PAT) Tools in Chemical Development

In the pharmaceutical industry, the pressure to decrease development times for new chemical entities is common.  During the recent 17th International Process Development Conference, Terry Connelly of Pfizer discussed this particular challenge during the presentation “Examples of Early Phase Implementation of Process Analytical Technology (PAT) Tools:  Meeting Short Term Goals While Setting the Stage for Long-Term Process Understanding and Control”.
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The Future of Chemical Research and Development: The Demise of the Round Bottomed Flask

ISPE-New-England-Chapter-BioPharma-ConferenceLast Thursday, May 6th, I attended the ISPE (International Society for Pharmaceutical Engineering) New England Chapter Biopharma 2010 Conference held in Warwick, Rhode Island.  A presentation was given by Geraldine Taber, Pfizer’s Global Technology Group Leader titled “Demise of the Round-Bottomed Flask – How new Battle Tools in the Lab of the Future are delivering value for R&D”.

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A Conversation with Danny Levin at Scientific Update’s January 2010 Organic Process R&D Meeting in San Diego


OPRD-Norac-Pharma-Danny-Levin-Dominique-Hebrault

Figure 1 - Summary of OPRD article by Danny Levin et al

I recently had a chance to meet with Danny Levin, President at Norac Pharma, during the 21st International Conference on Organic Process Research & Development (Scientific Update), January 2010, San Diego, CA.

After my presentation at the Organic Process Research & Development (OPRD) conference, Danny Levin described a paper he published a few years ago when he was head of research at NPIL Pharma Torcan (Org. Process Res. Dev., 2006, 10(6), pp 1296–1298). I had already used Danny Levin’s paper several times in my conference talks (figure 1) to illustrate the power of heat flow (Tr-Tj) at small scale, and Danny graciously provided some additional insight:

“I thought you might be interested in a publication of my own where I used METTLER TOLEDO MultiMax to good purpose in identifying and mitigating process scale up safety concerns during process development of a Horner Wadsworth Emmons reaction […]

The situation with the case study that I published was that we had been given a chemistry procedure that was believed by the originator to be safe and under control by virtue of slow addition of reagents. The MultiMax plot of (Tr-Tj) showed that this wasn’t the case – reagents were accumulating and the reaction and all the significant heat output occurred during warming for work-up!!!

It was the MultiMax data that quickly demonstrated the scale up hazard and allowed us to define a safely scaleable process. This critical aspect was not obvious from the presentation summary you kindly sent. You may wish to emphasize this point in future presentations to demonstrate the role of MultiMax in identifying and highlighting unsafe chemistry”.

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Pfizer YouTube video: Process Analytical Technology – Using Mid-IR spectroscopy to monitor a telescoped chemical reaction

Ian Clegg, an Associate Research Fellow at Pfizer Global Research and Development Sandwich Laboratories, United Kingdom recently posted a discussion on LinkedIn’s Process Analytical Technology (PAT) group site titled “PAT data (Mid-IR) posted onto YouTube.”

This YouTube video is entitled “Process Analytical Technology: Using Mid-IR spectroscopy to monitor a telescoped chemical reaction.”

httpv://www.youtube.com/watch?v=EWec0O6WtUU

In this video, 3 sequential chemical reactions are run in one vessel without stopping or isolating between reactions, and ReactIR™ (real-time in situ reaction analysis) is used to monitor all 3 reaction phases. All of the key reagents, intermediates and products produce unique peaks which show reaction progression without having to take samples. The video shows the spectra of the reaction as a function of time and how the spectra change. The video shows clearly which peaks were monitored and to which components those peaks correlate.

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Reducing Time to Manufacturing Using Real-time In Situ FTIR Analytics as a Process Analytical Technology (PAT) Tool – On-Demand Webinar

The on-demand version of the Reducing Time to Manufacturing Using Real-time In Situ FTIR Analytics as a Process Analytical Technology (PAT) Tool webinar that I presented on January 20 is now available.

View the Reducing Time to Manufacturing On-Demand Webinar.

FTIR-Analytics-Process-Analytical-Technology-Will-Kowalchyk

During this on-demand webinar, I review case studies from the pharmaceutical industry to show how real-time mid-infrared (mid-IR) analytics provide critical information that results in shorter process development timelines, including:

  • Intermediate detection during an indazole alkylation and scale-up – Pfizer
  • Hazardous gas detection during tetrazole synthesis – Merck
  • Monitoring a Grignard reaction at the multikilogram scale – Bristol-Myers Squibb
  • Scale-up involving a sensitive enolate – Johnson and Johnson (J&J)

If you have any questions or would like to discuss this further, then please contact me.