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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…

Rapid microbiology: Solutions for the next stage

20 July 2006 | By Tim Lloyd, Editor, European Pharmaceutical Review

Rapid microbiology is an exciting field for the development of new technologies and applications. There are significant challenges to be overcome and in doing so, great prospects for microbiologists and the companies that provide cutting-edge equipment.

Maintaining vaccine security

20 July 2006 | By Howard Smith, Technical and Commercial Manager, Cambridge Biostability

Ninety per cent of the world’s medical research funding is being spent on just ten per cent of the world’s health problems, mostly those afflicting the residents of wealthy countries.

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…

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.

Co-operation through certification

24 March 2006 | By Bengt Ljungqvist, Ph.D. and Berit Reinmüller, Ph.D. KTH Stockholm

To verify that cleanroom and clean zones are adequately installed and functioning they are usually validated during three occupancy states. First, when the installation is complete with all services connected and functioning, as-built; secondly during at-rest conditions when equipment is installed and running in a manner agreed upon by customer…

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…

Opportunities for Rapid Microbial Methods

2 February 2006 | By Anthony M. Cundell, Ph.D. Consulting Microbiologist

Since the 2000 publication of the PDA Technical Report Number 33 Testing Methods, rapid microbial methods (RMM) have not lived up to their promise for changing routine Quality Control microbiological testing in the pharmaceutical industry. With the next generation of rapid microbial methods emerging from the R&D laboratories of instrument…

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…

Microbial detection in mammalian cell culture systems

11 November 2005 | By Amy McDaniel, Ph.D., QC Manager, Microbial Science & Technology, Wyeth Biotech

Timely results for microbial bioburden monitoring of in-process cell culture samples are critical to the production process for recombinant proteins and other biopharmaceutical products.

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.

International standards: a tool for compliance

22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting

Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.

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…

Implementation, validation and registration

20 May 2005 | By Paul J Newby PhD, GlaxoSmithKline R&D

In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and…

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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