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PAT: a comprehensive guide
23 January 2008 | By
European Pharmaceutical Review presents a comprehensive guide to PAT addressing the challenges and advancements that are impacting upon PAT implementation in 2008 and beyond...
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Process Analytical Technologies (PAT)
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The future direction of ASTM E55 Committee on manufacture of pharmaceutical products
23 November 2007 | By Steve Simmons, Head of Process Knowledge QbD, Wyeth Pharmaceuticals
ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus…
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An eight-step Six Sigma toll-gate approach to PAT implementation
21 September 2007 | By Bikash Chatterjee, President of Pharmatech Associates, Inc and Jeremy Green, Senior Consultant for Pharmatech Associates, Inc.
The FDA’s recent guidance regarding Process Analytical Technology (PAT) offers the pharmaceutical and biotech industries an unprecedented opportunity to leverage hard-won experience with scientific inquiry and innovation. However, the leap to PAT is significant for even the most rigorous development program. Many aspects of Six Sigma; including its use of…
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Implementing Near Infrared Spectroscopy as a PAT tool in the biopharmaceutical industries
21 July 2007 | By Payal Roy-Choudhury, PhD Student, Fermentation Centre, Strathclyde Institute of Pharmacy & Biomedical Science, Glasgow, UK
Biopharmaceuticals are the fastest growing sector of the pharmaceutical industry[1]; with monoclonal’s being the key biopharmaceutical products representing a significant proportion of the current business focus. It is anticipated that this new generation of biopharmaceuticals will revolutionise clinical medicine over the next 5-10 years.
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A “PAT” on the back for Rapid Microbiological Methods
21 July 2007 | By Robert Johnson, Director, Dialogue
The modern microbiological laboratory needs to change and become more innovative in its approach to microbial detection, enumeration and identification.
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Process Analytical Technologies (PAT) in the pharmaceutical industry
European Pharmaceutical Review brings you a comprehensive guide to the current developments and possible future innovations within Process Analytical Technologies...
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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.
