Process Analytical Technologies (PAT)

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PAT and design science

23 May 2007 | By Carl-Fredrik Mandenius, Micael Derelöv, Jonas Detterfelt, Mats Björkman, Division of Biotechnology/IFM and Division of Production Systems/IKP, Linköping University, Sweden

Process analytical technology (PAT) and mechanical design science are interconnected; this article describes how a well-established design modelling approach; the Hubka-Eder model, is applied to the concepts of PAT and quality by design (QBD). The model connects PAT with quality management concepts as defined for PAT by the ICH guidelines…

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EuPAT: an initiative to promote progress in the science underpinning PAT

23 May 2007 | By Staffan Folestad, Senior Principal Scientist, AstraZeneca, Sweden; Peter York, Bradford University, UK, and Rasmus Bro, Copenhagen University, Denmark

A new initiative launch has been announced that aims to promote progress in the science underpinning Process Analytical Technology. The core purpose of the EuPAT meeting is the creation of an open and neutral scientific forum for sharing and discussing new findings in cutting-edge scientific research, development of enabling technologies…

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PAT and scalable automation for bioprocess control and monitoring

27 March 2007 | By Joydeep Ganguly, PAT Group Lead and Gerrit Vogel, Senior Engineering Manager, Talecris Biotherapeutics

This case study provides a comprehensive look at Talecris1 Biotherapeutics’ approach to PAT and automation followed by examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts and explains how the selected automation effectively supports initiatives such as…

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PAT for freeze drying: cycle optimisation in the laboratory

25 January 2007 | By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg

Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying…

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PAT for the product lifecycle of a biopharmaceutical product

25 January 2007 | By Ronan O’Kennedy, Biopharmaceutical Process Development, Biopharmaceutical CEDD, GlaxoSmithKline

The biopharmaceuticals industry has undergone a number of revolutions in the past decade, not least the variety of ‘omics’ that focus on high throughput technologies to identify new product targets and can rapidly characterise those targets at small scale. However, it has been widely recognised that the technology used in…

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Wyeth forges ahead

28 September 2006 | By Graham Cook Ph.D., Director Technology and External Supply, EMEA, Wyeth

Is the pharmaceutical manufacturing environment of today becoming more challenging? There is increasing pressure to control or reduce costs because of the limitations on healthcare budgets. Asset utilisation, operating efficiencies and cycle times in the pharmaceutical industry generally compare unfavourably with other high technology industries. Despite the resources invested in…

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The business benefits

20 July 2006 | By Jean-Marie Geoffroy, Ph.D., Director, Pharmaceutical Development, TAP Pharmaceuticals, Inc.

So far in 2006 we have published contributions on a variety of PAT-related topics, including training (Issue 1), NIR (Issue 2) and the role of PAT in biotechnology (Issue 3). In this article Jean-Marie Geoffroy reports on the business case for PAT with his own interpretation and charts the road…

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The role of PAT in biotechnology

23 May 2006 | By Carl-Fredrik Mandenius, Linköping University, Sweden, Member of the European Federation for Pharmaceutical Sciences PAT Steering Group

Product quality of pharmaceuticals manufactured in biotechnology processes is to a large extent synonymous with the reduction and control of unwanted biological side-products. Production of biopharmaceutical proteins and secondary metabolites such as antibiotics are the result of biosynthetic capacity of the microbes or cells used. But this capacity may also…

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A vision for the future

24 March 2006 | By Dr. Manuela Scholz, Leiter der Herstellung (Product Supply Release Responsible), Procter & Gamble Pharmaceuticals

Due to the need for improvement in the cost structure and efficiency of the pharmaceutical industry, the introduction of NIR analytical techniques in combination with PAT applications is a promising opportunity for cycle time reduction and machine utilisation increase.

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Cost, knowledge and convenience: facing the facts

2 February 2006 | By Professor David Littlejohn, Head of the Department of Pure and Applied Chemistry at the University of Strathclyde, Director of CPACT at the University of Strathclyde

There can be no doubt that the FDA’s initiative on Process Analytical Technologies (PAT) has had an enormous impact on the pharmaceutical industries. However, the emergence of ’born again‘ PAT devotees in pharma companies has caused mild amusement in other industries where on-line analysis has been an integral part of…

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Mass Spectrometry: another tool from the PAT toolbox

11 November 2005 | By Steve Doherty and Aaron Garrett, Manufacturing Science and Technology, Mark LaPack, Process Research and Development, Eli Lilly and Co.

Optical techniques can not address every application need, so the well-equipped PAT toolbox must include a broad array of technologies. One analytical tool that has been less-published but no less useful than the optical methods is mass spectrometry. This article provides a brief review of some of the published uses…

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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…