Author Archives: Patricia Hicks

强生怎样取代了圆底烧瓶

Janssen制药比利时是强生―世界最大的健康维护公司―的一部分。多谢强生广泛地致力于创新科学、并投资在高等教育人才和先进研究设备上,Janssen制药享受着制药创新和质量的国际声誉。

用EasyMax更快更好更高效早于2008年,Janssen就开始投资于合成工作台:EasyMax™。自那时起, EasyMax™ 已被成功地用在Janssen的实验室里,并已很大程度上取代了传统的圆底烧瓶。EasyMax™ 现在已成为Janssen制药的一种标准合成工具、不可从化学开发实验室里被排除。

在一年多的时间里,几套EasyMax™系统被一组搞化学开发的化学家们作了全面的评价。这一广泛的评价证实了化学合成生产率可得到充分提高。在EasyMax™ 中进行的实验提供准确的、可重复的、和高质量的信息,从而使科学家们能够在大量减少试剂和溶剂消耗的同时开发出更稳健的工艺过程。

根据Luc Moens, 在强生比利时的化学研究与工艺开发研究员,EasyMax™ 所提供的投资回报包括:

  • 减少试验次数
  • 节省时间,以便作其它工作
  • 提高化学开发的生产率
  • 提高实验和结果信息的质量
  • 减少试剂和溶剂消耗

Challenges of Continuous Flow Chemistry

During the recent online seminar – Application of the ReactIR Flow Cell to Continous Processing Technology, Professor Steven Ley discussed the challenges of continuous flow chemistry.  According to Professor Ley, one of the main challenges of continuous flow chemistry is real-time inline reaction monitoring for gaining additional control over reactions, especially when dealing with multistep synthesis sequences.

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辉瑞是如何帮助实验科研人员改进工艺过程开发的

EasyMax at Pfizer

Marty Guinn博士, 辉瑞

辉瑞药疗化学开发部主任Marty Guinn博士近来给出以下描述:

“生产率、重复性、和可信度对我们是重要的。根据我们的经验,EasyMax满足所有的要求,它并且为实验科研人员要改进工艺过程开发效率打开了自动化潜力之门。目前,我们的化学家与工程师们天天都在将EasyMax用于进行早期和后期工艺过程开发的各种各样应用上。我们正在积极地把基本的EasyMax分布给具体使用者,同时随着他们的信心和创造性的提升容许他们逐个地升级到更先进的系统。我们已经建立了数多‘走上式’(walk-up) EasyMax工作台,每个工作台通过iControl 操作控制数台EasyMax系统以便让工艺过程化学家门进行DoE(实验设计)实验。”

身为辉瑞药疗化学开发部主任, Guinn博士管理着工艺过程化学技术组和结晶技术组。工艺过程化学技术组进行高通量平行实验和DoE实验,同时使用先进的工艺过程研究技术(ReactIR、连续流动化学、等)来支持早期原料药(API)工艺过程开发以及临床实验需求。结晶技术组为寻找适合的药型进行盐型和多晶型筛选,同时为提供原料药(API)开发过硬的结晶工艺过程。

FDA对药品开发行业质量源于设计的观点

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

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

Chilworth’s Safe Scale-up of Chemical Processes

safe-scale-up-chemical-processes-webinar

Safe Scale-up of Chemical Processes

On July 1, Dr. Stephen Rowe of Chilworth Technology will present Safe Scale-up of Chemical Processes: Holistic Strategies Supported by Modern Tools.

This online process safety seminar will focus on the overall safety strategy and outlines:

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

How To Optimize A Highly Reactive Chemistry

Highly Reactive Chemistry

Highly Reactive Chemistry

Highly reactive chemistries are used in the syntheses of drug molecules, special polymer products, herbicides and other agriculture products, high energy materials, and even special materials like nano-particles and chemo-sensors.

Examples of highly reactive chemistries include:

  • Azide chemistry
  • Diazo chemistry
  • Grignard chemistry
  • Lithium chemistry
  • Phosgene chemistry

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BIWIC 2010: Optimization & Scale-up of Anti-Solvent Crystallization

Later this week, scientists and engineers will join together at Martin Luther University Halle-Wittenberg in Germany for the BIWIC 2010 – International Workshop on Industrial Crystallization.  Topics at this year’s International Workshop on Industrial Crystallization will include fundamentals of crystallization (thermodynamics and kinetics), process design (monitoring and modeling), product design (polymorphism, salvation, stability, chiral separation, fine chemicals, pharmaceuticals), industrial applications, and intensified processes and equipment (external fields, micro technology, hybrid processes). Continue reading