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19 June 2008 | By Graham Cook PhD, Senior Director, Process Knowledge/Quality by Design, Wyeth Pharmaceuticals
In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to…
19 June 2008 | By
PAT implementation gurus’ Expo Technologies talks to European Pharmaceutical Review about PAT and why they are at the top of their game.
19 June 2008 | By
MicroRNAs (miRNAs) are a class of small non-coding RNA molecules, which are potent post-transcriptional gene expression regulators. They have been shown to participate in the regulation of numerous cellular processes, the list of which is still growing. miRNAs affect numerous targets that can be determined by direct experiments or predicted…
19 June 2008 | By
The ease in making process analytical measurements (typically spectroscopic) in manufacturing has provided a unique opportunity to obtain up-to-date information for making timely process correction decisions. At-line methods provide near-time information without the need for elaborate process control interfacing upfront. This approach works well for batch processing applications or unit…
19 June 2008 | By
Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector 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…
7 April 2008 | By
There has been much interest in the promise of proteomics to deliver biomarkers with utility for disease diagnosis and classification, and for assessing therapeutic efficacy and monitoring disease progression. However recently, particularly in the past year, expressions of concern have started to emerge regarding the paucity of protein biomarkers that…
7 April 2008 | By
One of the most profound advances in biology and medicine has been the sequencing of entire genomes, including the human genome. The end product was the availability of the complete genetic blue print of organisms of importance to medicine and biotechnology. This changed how we conducted science. Cloning individual genes…
7 April 2008 | By
Laboratory automation development is being increasingly outsourced to the commercial market according to a recent industrial member survey by the Association for Laboratory Automation (ALA). ALA polled 400 of its members in industry with 14 questions and received 72 responses representing 47 different companies in the Pharma, Biotech and Agriculture…
7 April 2008 | By
Recent years have seen great upward leaps in the development of mass spectrometry applied to the field of proteomics. Today it is possible to take a complex biological sample such as organelles, cells, tissue or a biofluid, perturbed or stimulated in some way, and identify and quantitate up to several…
7 April 2008 | By
The increasing need for improved efficiency, precision and 24/7 operation imply more and more sophisticated measures in laboratory automation. This is true for a variety of fields – from pharmaceutical to food, agricultural, and the petrochemical industry, as well as forensics and medical diagnostics. Chemical and biological tests have to…
7 April 2008 | By
Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are…
7 April 2008 | By
The pharmaceutical industry has, for many years, operated in a special environment with strong regulation and patent protection. Production efficiency and yields have not, as in many other industries, been the major competition parameter and, as a result of this, pharmaceutical manufacturing has a low manufacturing performance compared to other…
7 April 2008 | By
Pharmaceutical analysis in drug development mainly focuses on methods to identify and quantify potential new drug candidates, determine purity, identify by – products and degradation products in compatibility and stability studies, and to determine the drug substance’s fate in the organism. Challenging tasks like these require sophisticated techniques, dedicated equipment…
7 April 2008 | By
It is clear that pharmaceutical analysis plays a very important supporting role in drug development. Already during the conception of a candidate drug, for example by chemical synthesis, suitable analytical means are required to determine the identity and purity of the compound. Subsequent studies performed on candidate drugs with the…
7 April 2008 | By
Contract Research Organisations (CROs) provide independent development services for pharma, biotechnology, and medical device markets. Services offered by CROs have evolved from providing basic support, to a wide range of services catering to various needs of the market and the sponsors. The United States is the world’s largest market for…
