PAT - Articles and news items

PAT for the product lifecycle of a biopharmaceutical product

Issue 1 2007, Past issues / 25 January 2007 / 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 the manufacturing of these in new products has lagged behind. In many respects, Process Analytical Technology (PAT) is a new ‘omics’ for biopharmaceutical manufacture.

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Wyeth forges ahead

Issue 5 2006, Past issues / 28 September 2006 / 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 compliance, many companies continue to struggle to meet the regulatory requirements, as evidenced by warning letters and consent decrees.

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The business benefits

Issue 4 2006, Past issues / 20 July 2006 / 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 ahead.

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The role of PAT in biotechnology

Issue 3 2006, Past issues / 23 May 2006 / 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 contribute to turn the product molecules into molecular forms unacceptable in the final product, form side-metabolites that could harm the cell physiology and release contaminating cellular components. The main task for the ensuing process steps, the downstream procedures, is to reduce these impurities to acceptable levels that comply with the regulatory quality criteria.

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A vision for the future

Issue 2 2006, Past issues / 24 March 2006 / 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

Issue 1 2006, Past issues / 2 February 2006 / 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 (more…)

Mass Spectrometry: another tool from the PAT toolbox

Issue 4 2005, Past issues / 11 November 2005 / 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 of process mass spectrometry, and provides some specific examples from the authors’ labs that demonstrate the value and utility of this technique.

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A Pfizer perspective

Issue 3 2005, Past issues / 22 August 2005 / 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

Issue 2 2005, Past issues / 20 May 2005 / 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 industry also employs, directly and indirectly, large numbers of people.

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A process analytical tool

Issue 1 2005, Past issues / 7 March 2005 / 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 analytical tool.

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PAT for API

Issue 1 2005, Past issues / 7 March 2005 / 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.

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