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Issue 4 2013



ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities

20 August 2013 | By

The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…


Proteases: How naturally occurring inhibitors can facilitate small molecule drug discovery for cysteine proteases

20 August 2013 | By Sheraz Gul, Vice President and Head of Biology, European ScreeningPort GmbH

Cysteine proteases are expressed ubiquitously in the animal and plant kingdom and are thought to play key roles in maintaining homeostasis. The aberrant function of cysteine proteases in humans are known to lead to a variety of epidermal disease states such as inflammatory skin disease1. In marked contrast, the serine…


Six Sigma: How Rottapharm is using Lean Six Sigma principles

20 August 2013 | By Richard Hayes, Continuous Improvement Manager, Rottapharm

From their headquarters based in Monza, Italy, Rottapharm’s long history of success began in 1961 with the creation of a small laboratory for independent research. The company from its early beginning has continuously invested in research, innovation and development of pharmaceutical products for distribution on a worldwide scale. After acquiring…


Raman spectroscopy: an enabling tool for accelerating pharmaceutical discovery to development

20 August 2013 | By Chanda R. Yonzon, Atul Karande, Sai P. Chamarthy and Brent A. Donovan (Merck & Co. Inc)

Raman spectroscopy has emerged as the preeminent analytical tool for a number of applications within drug discovery and development. Advances in the instrumentation, sensor fabrication and data analysis have enabled the wider acceptance of Raman spectroscopy1,2. In discovery, Raman spectroscopy is used to elucidate structural activity relationships3 and to optimise…


Chloride ion channels and transporters: from curiosities of nature and source of human disease to drug targets

20 August 2013 | By Jonathan D. Lippiat, School of Biomedical Sciences, University of Leeds

Early in their undergraduate education, the student is introduced to various types of integral membrane protein: receptors, adhesion proteins, ion channels, ion pumps and ion transporters. As they progress through their studies, they find out that discrete gene families and protein structures are responsible for these different protein classes and…


GPCRs: Cell based label-free assays in GPCR drug discovery

20 August 2013 | By Niklas Larsson, Linda Sundström, Erik Ryberg and Lovisa Frostne (AstraZeneca)

G protein-coupled receptors are one of the major classes of therapeutic targets for a broad range of diseases. The most commonly used assays in GPCR drug discovery measure production of second messengers such as cAMP or IP3 that are the result of activation of individual signalling pathways. Such specific assays…