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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…

New opportunities for understanding

23 May 2006 | By Lubomir Gradinarsky, Jonas Johansson, Mike Claybourn, Husheng Yang, Matti U.A. Ahlqvist and Staffan Folestad, Pharmaceutical and Analytical R&D, AstraZeneca R&D Mölndal

By taking advantage of new technology previously developed mainly for radio astronomy, biological investigations and military applications, the emerging field of Terahertz (THz) Spectroscopy is starting to make its way into pharmaceutical analysis. This overview describes the new opportunities with THz Spectroscopy for rapid and non-destructive analysis of pharmaceutical materials…

Lyophilization: An ever-evolving technology

23 May 2006 | By Prof. Louis Rey, Scientific Advisor and Head, Laboratory of Experimental Freeze-Drying AERIAL – CRT, and Dalal Aoude-Werner, Head of Project, AERIAL – CRT

Almost 60 years have elapsed since freeze-drying/lyophilization was introduced on an industrial scale. Developed initially for the rapid delivery of human blood plasma on the World’s battle fields, lyophilization gained its credentials with the massive production of penicillin under the guidance of the late Nobel Laureate Sir Ernst Boris Chain.

Partnering for better science

23 May 2006 | By Hans Hultberg, Head of Global Discovery Alliances, AstraZeneca

There are nearly 12,000 people within the AstraZeneca R&D community who all share a common aim: to bring life-changing medicines to patients as quickly as possible. Our efforts are evident in a rich research history that has delivered new treatments for gastrointestinal, cardiovascular, neurological and respiratory diseases, along with pioneering…

Is Pharma getting what it needs from RNAi?

24 March 2006 | By Steven A. Haney, Department of Biological Technologies, Wyeth Research

Large and small drug development companies have used RNAi intensively for several years now1-3. The adoption of RNAi technologies by drug companies followed fairly closely with their adoption by academic research labs, and as such many of the challenges and problems that were a natural consequence of the rapid expansion…

Identification and prevalidation of safety biomarkers

24 March 2006 | By Michaela Kroeger, Merck KGaA, Institute of Toxicology, Matthias Glückmann, Applied Biosystems, Mass Spectrometry and Proteomics

To date, hazard/risk assessment of new drugs and chemicals primarily relies on the investigation of toxicological endpoints from animal studies. In this field, the full range of genomics and proteomics technologies can be used in efforts to uncover the molecular mechanisms at work in response to xenobiotic exposure. These new…

Real-time PCR: clinical applications

24 March 2006 | By Lut Overbergh and Chantal Mathieu, Laboratory for Experimental Medicine and Endocrinology (LEGENDO), University Hospital Gasthuisberg, Catholic University of Leuven

The real-time PCR technique is one of the emerging techniques that, although only described for the first time about a decade ago, have become the method of choice for quantification of DNA and RNA levels in cells, tissues and tissue biopsies.

Critical success

24 March 2006 | By Maria L. Garcia and Gregory J. Kaczorowski,Department of Ion Channels, Merck Research Laboratories

The extensive amount of knowledge accumulated over the last few years on the physiological importance of ion channels and, consequently, the broad expectation that drugs which modify the activity of these proteins could have therapeutic benefit, has triggered resurgence in the study of ion channels in both academic and pharmaceutical…

Carving a niche in the realm of drug discovery

24 March 2006 | By Charanya Ramachandran, Research Analyst, Drug Discovery Technologies, Frost & Sullivan Healthcare (EMEA)

Molecular technologies such as genomics and proteomics have brought in a thorough make-over to early stage drug discovery. The strategic spotlight from the genomics technologies has gradually shifted focus to the cellular domain where the entire drug target interaction takes place. As a result, cell based screening provides promising potential…

Quality through collaboration

24 March 2006 | By EPR

Marc Casper, Senior Vice President, Thermo Electron Corp., believes there are exciting times ahead for R&D and that collaborations will speed the development of the tools required. Tim Lloyd found out more.

RS coupled to separations

24 March 2006 | By Cees Gooijer, Freek Ariese and Reyer J. Dijkstra, Dept. of Analytical Chemistry and Applied Spectroscopy, Laser Centre Vrije Universiteit

Currently, Raman spectroscopy (RS) is rapidly becoming a mature analytical technique in the pharmaceutical world. Thus far, it is used almost exclusively in a stand-alone mode, since coupling with liquid separation methods hardly seemed realistic in practice. However, as outlined in this article, recent developments are quite promising and such…

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.

Synchrotron radiation: current status and future landscape

24 March 2006 | By E J MacLean, P J Rizkallah, CCLRC Daresbury Laboratory and J R Helliwell, School of Chemistry, The University of Manchester

Synchrotron radiation (SR) has had a profound impact on the capabilities of structural chemistry and biology. The first dedicated SR X-ray source was the UK’s SRS, which celebrated its 25th Anniversary in 2005. This article provides an overview and several case studies that illustrate the pivotal role that the pharmaceutical…

Advances in fast ion chromatography

24 March 2006 | By Charles A. Lucy and Sarah Pelletier, Department of Chemistry, University of Alberta

Ion chromatography (IC) allows the determination of trace ions using low capacity high efficiency columns possessing fixed ion exchange sites. Combined with suppressed conductivity detection, IC yields parts-per-billion detection of the seven common inorganic anions (F-, Cl-, NO2-, Br-, NO3-, HPO42- and SO42-) and to a lesser extent carboxylic acids,…

Integration is key

24 March 2006 | By E. Allen, T. Mant, C. Vose: Guy’s Drug Research Unit, Quintiles Limited

Drug development has become more complex and significantly more expensive. There has been an estimated 55% increase in the critical path development costs since the year 20001. More than 50% of these costs are incurred in later phase development (Phase IIb and III studies).