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In these economic times the pharmaceutical industry has expressed a renewed interest to explore ways in which to enhance the efficiency and agility of existing and future manufacturing processes. This is also true for laboratory-based operations that support forward processing and product release decisions. One function that can greatly benefit…
30 July 2009 | By
Drug transporters are membrane proteins involved in the uptake or efflux of drugs by several tissues such as the intestine, liver, kidney and brain. They can have a significant impact on the pharmacokinetics of endogenous and exogenous compounds. Also, co-administered drugs or nutrients can influence the transporter activity which may…
30 July 2009 | By Pedro E. Hernandez-Abad, Associate Director; Jun Huang, Principal PAT Scientist II and Saly Romero-Torres, Principal PAT Scientist, both Wyeth Pharmaceuticals
Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and…
29 May 2009 | By
In established economies, mental disorders account for a larger burden of disease than all cancers combined. Yet reliable, measurable, markers of such diseases (biomarkers) are not uniformly known and without them, prediction that a new drug candidate makes contact with its target is poor. This is unfortunate because the attrition…
29 May 2009 | By
The pharmaceutical industry continues to experience a high attrition rate during the latter stages of small molecule therapeutic development, most disappointingly during the late, and highly expensive stages of Phase II and Phase III trial1. If left unchecked, it is likely that this late-stage failure in drug development will only…
29 May 2009 | By
This meeting will look at recent advancements of proteomics for analysis across biological scales, i.e. from cells to tissues and organisms. The event aims to overcome the barriers and highlight the interfaces that allow us to take proteomics towards an integrative view of biology.
29 May 2009 | By
Real-time PCR (qPCR) data are reliable only if they result from a robust qPCR assay that has been carefully designed, validated and optimised. This process requires an extensive assay design procedure aimed at generating an optimum primer/probe/amplicon combination to allow accurate quantification of nucleic acids with minimum need for post-PCR…
29 May 2009 | By
Nearly fifty years ago, it was hypothesised that terminally differentiated cells such as fibroblasts could be forced to take on a pluripotent state, similar to the embryonic stem cells (ES cells). The basis of the concept is the observation that all cell types, with minor exceptions, have the same genetic…
29 May 2009 | By
Joydeep Goswami from Invitrogen, who provide essential life science technologies for disease research, drug discovery, and commercial bioproduction, talks to us about current and future developments at the company.
29 May 2009 | By
1. How significantly do you feel the Drug Discovery Process has benefited from the application of High Content Analysis techniques? Anthony Davies: Since the mid 1990's High-content analysis (HCA) has primarily been used in the later stages of the pre-clinical drug discovery process. However, as HCA techniques have developed and…
29 May 2009 | By
Much has been published elsewhere about the limitations of the compendial microbiological methods and the needs of current Pharmaceutical manufacturing, in particular related to the adoption of PAT as a quality tool1-4. Rapid Microbiology is seen by many as a tool for addressing a number of these limitations5,6. Rather less…
29 May 2009 | By
As the time-to-market of pharmaceutical products has elongated, while its prices are under big pressure, cost saving is currently essential in the pharmaceutical industry.
20 March 2009 | By
For years biologists have worked to develop alternatives to traditional therapeutics. These efforts, in areas such as stem cell based and gene therapies, have received much fanfare in popular media outlets, raising expectations among the general public. This excitement may have contributed to the hasty progression of early gene therapy…
20 March 2009 | By
The fluorescence-based quantitative real-time polymerase chain reaction (qPCR)1-3, is the most widely used method to detect and measure minute amounts of DNA in a wide range of samples extracted from numerous sources. Since all currently available thermostable polymerases are DNA-dependent, RNA must be converted ("reverse transcribed") into DNA prior to…
20 March 2009 | By
Generating knowledge and insight from complex genomic data sets is always a challenging endeavor. As data collection becomes more routine and less expensive, and the existing body of data expands, getting the most out of genomics experiments requires ever more expertise and insight. Here, we discuss our method of integrating…
