Process Analytical Technologies (PAT)

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The current state of PAT in freeze drying

11 November 2005 | By Michael Wiggenhorn, Gerhard Winter, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University and Ingo Presser, Boehringer Ingelheim

Freeze drying is a widely used method to stabilise protein pharmaceuticals. The stability of proteins and the biological activity can be influenced by several factors, which may lead to conformational changes and to denaturation, aggregation or absorption to surfaces1.

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A Pfizer perspective

22 August 2005 | By Joep Timmermans, Ph.D., Senior Manager/Team Leader, Process Analytical Support Group – Americas Implementation Team, Pfizer Global Manufacturing

While the current attention and focus on Process Analytical Technologies (PAT) may make you believe otherwise, PAT measurement systems have been used in the pharmaceutical industry, Pfizer included, for some time, albeit often to a limited extent.

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Harbinger of change

20 May 2005 | By Ali Afnan, Ph.D., Process Analytical Technologist, FDA/CDER/OPS

The pharmaceutical industry plays a major role in the lives of individuals by providing critical therapeutic medicines. This places the industry in the public eye, as does drug pricing, safety and efficacy, the stock markets and courting with several different regulatory bodies, with differing legal requirements, around the world. The…

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A process analytical tool

7 March 2005 | By Jukka Rantanen, Senior Research Scientist, Viikki Drug Discovery Technology Centre, University of Helsinki

There is an increasing demand for new approaches to understand the chemical and physical phenomena that occur during pharmaceutical unit operations. Obtaining real-time information from processes opens new perspectives for safer manufacture of pharmaceuticals. Raman spectroscopy provides a molecular level insight into processing and it is therefore a promising process…

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PAT for API

7 March 2005 | By Dirk C. Hinz, Ph.D., Schering AG, Corporate CMC Development, In-Process Control Dept.

Pharmaceutical manufacturing occurs in a highly regulated environment, where most of the manufacturing is performed in batches, in stop-and-go steps and with off-line testing of product quality. Additionally, due to patent restrictions, there is always ‘speed to market’ pressure.