Informatics In-Depth Focus 2013
IN this Informatics In-Depth Focus: Using LIMS for biobanking and implementing LIMS for research; Biologics development and ELN: A good match?; Informatics Roundtable...
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Articles
RMMs & Environmental Monitoring In-Depth Focus 2013
In this RMMs & Environmental Monitoring In-Depth Focus: The rapid microbiological methods revolution; Controlling contamination in the pharmaceutical industry; Rapid Micro Methods Roundtable...
ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities
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…
Issue #3 2013 – Digital version
Read the free digital version of the June / July edition of European Pharmaceutical Review magazine...
Screening In-Depth Focus 2013
In this Screening In-Depth Focus: New approaches to cell based assays for high content screening and analysis; Reduce, reuse, recycle: how drug repositioning is finding its niche in drug discovery; Workshop Review: Biochemical assays for screening. Screening roundtable...
Ingredients In-Depth Focus 2013
In this Ingredients In-Depth Focus: Revisiting a mutual recognition agreement approach for GMP inspections to secure the safety of the supply chain of APIs; Solid form diversity of commonly used tableting excipients and its impact...
New guidelines for breakmarks on tablets
13 June 2013 | By Tony Moffat, UCL School of Pharmacy and Joint Pharmaceutical Analysis Group
The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).
The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies
13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com
This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…
Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes
13 June 2013 | By Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey, University of Strathclyde
Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that offer benefits such as shorter time lines, improved consistency, higher monoclonal antibody (mAb) production, better genetic stability and increased flexibility. Each of these advantages extends a potentially large cost benefit to companies as their recombinant protein products…
Raw material identity verification in the pharmaceutical industry
Inspection of incoming raw materials is an essential step in the pharmaceutical industry to verify that the correct raw material which meets the quality specifications has been received. It will not only help to ensure that the final product is of best quality and minimise wasted time, material costs and…
