List view / Grid view
25 January 2007 | By Dr Andrew M. Middleton, GlaxoSmithKline
Subsequent to the publication of the PDA technical Report Number 33 in 20001 there has been a multitude of articles published in pharmaceutical reviews and commentaries with regard to rapid microbial methods (RMM). The majority of these articles cover, to a greater or lesser degree, the technologies available and summaries…
28 November 2006 | By Andy Chang and Jean-Philippe Stephan Ph.D., Assay and Automation Technology department, Genentech, Inc
During the last decade, technical developments have dramatically changed the way cell-based assays could be implemented and used in research and development organisations. Although cell-based assays have moved into a modern era, cells are still grown and maintained in the same way as decades ago; i.e. manually. However, automation systems…
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…
28 September 2006 | By Tony Cundell, Director, Pharmaceutical Sciences – Microbiology, Schering Plough Research Institute
Following on from our latest report in Issue 4 in which we outlined independent views on ‘solutions for the next stage’ in Rapid Microbiological Methods (RMM) from some of the industry’s leading names, Tony Cundell follows up with his own thoughts on this exciting field.
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…
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.
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.
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…
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.
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…
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…
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…
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…
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.
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.
