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23 December 2014 | By Axel Ducret, Biochemist
This article will focus on some of the critical aspects of transition biomarkers discovered in classical (MS-based) proteomics workflows and on the challenges to be met before validated assays can become more routine in the clinical laboratory...
23 December 2014 | By Dr Tim Sandle, Bio Products Laboratory
This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology...
23 December 2014 | By Paul McCracken & Stephen Krause
The cost of drug discovery and development, depending upon the size of a given company, has been estimated upwards of $5 billion. Hay et al. recently published a review of clinical development success rates showing only a 10.4% likelihood of regulatory approval of all drugs entering Phase I, 64.5% of…
23 December 2014 | By Natalia Meani and Manuela Vecchi
Recognised as one of the major scientific breakthroughs of the 20th century, polymerase chain reaction (PCR) is a quick and simple method to create, in a test tube, millions of copies of a given DNA segment from a complex mixture of genetic material. This method has greatly stimulated biochemical, molecular…
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
In this issue: Protein Characterisation, RMM, Flow Cytometry, Spray drying, NMR spectroscopy, Raman, Pharmaceutical salts, Sterile Control Strategies and much more...
Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable...
Sulaf Assi discusses the investigation of medicine quality using handheld Raman spectroscopy, a look at Raman hyperspectral imaging, plus Raman roundtable...
Crystallography is the science underpinning crystallisation, as well as a basic understanding of atomic arrangement within solids and their resulting structures. The United Nations announced that 2014 would be the International Year of Crystallography (IYCr2014). IYCr2014 commemorates the 100th anniversary of X-ray diffraction according to Bragg’s Law (celebrated by the…
28 October 2014 | By Rick Davies, Associate Director, AstraZeneca / Ian Hardern, Senior Research Scientist, AstraZeneca / Ross Overman, Associate Principal Scientist, AstraZeneca
Recombinant protein production is a prerequisite and essential component of most modern small molecule drug discovery programs. Target proteins are required to underpin screening, structural and mechanistic studies providing data that drives chemical design. From the initial establishment of recombinant protein production in the pharmaceutical industry in the 1980s, systems…
28 October 2014 | By Tim W. Overton, Lecturer in Bioengineering, University of Birmingham
Flow cytometry is an extremely useful technique for the rapid analysis of many cell types. Here, the applications of this technique for the monitoring and optimisation of microbial recombinant protein production processes are discussed.
Spray drying is one of the most remarkable technologies currently to be applied to pharmaceuticals. It is a continuous process that converts, in a single step, a liquid feed into a powder and is an ideal process when precise attributes such as particle size, morphology and stability are required. This…
28 October 2014 | By Torgny Rundlöf, Pharmaceutical Evaluator, Medical Products Agency, Sweden
Pharmaceutical products have to be of high quality with respect to a number of predefined attributes, e.g. identity and strength with respect to the active pharmaceutical ingredient (API) and the presence and levels of impurities. At least for smaller compounds, such quality control often involves chromatographic methods. The examples given…
28 October 2014 | By Axel Becker, Scientist, Merck KGaA
Over the past decades, pharmaceutical drug development has undergone some significant changes, a prominent example for this being the emergence of biomolecular drugs (New Biological Entities, NBEs) such as antibodies and peptides. However, classical small molecule drugs (New Chemical Entities, NCEs) are far from being a dying species, and in…
28 October 2014 | By James L. Drinkwater, F Ziel Head of Aseptic Processing Technology/GMP & Chairman of Pharmaceutical and Healthcare Sciences Society
Control strategies are often implemented when developing drugs and manufacturing biological and therapeutic products, however, increasingly they are considered important in the manufacture of sterile medicines. A control strategy for manufacturing sterile pharmaceutical products and substances sets out a documented approach and rationale taken to control product quality, efficacy and…
