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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
India announces expanded pharma growth at CPhI
25 October 2013 | By Dr Kevin Robinson
CPhI Worldwide 2013: eight halls, more than 30,000 attendees from 140 countries and 2200 exhibitors. The “world's leading pharmaceutical networking event,” colocated with ICSE, P-MEC and InnoPack, was back in Frankfurt, Germany, and my mission was to find a single coherent take-home message...
ICH Q3D: Metal Impurities: A Critical Evaluation
22 October 2013 | By David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca
Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) .
Practical considerations in analysing biologically active peptides by Electrospray Ionisation (ESI) Mass Spectrometry
22 October 2013 | By Birthe V. Nielsen, Faculty of Engineering and Science, University of Greenwich
Neuromodulators such as calcitonin gene-related peptide (CGRP) and vasoactive intestinal peptide (VIP) act as biomarkers for pain assessment (pre-clinical). These markers can be detected at low concentrations by Electrospray Ionisation (ESI) Mass Spectrometry (MS). Currently, little is known about the factors affecting responsiveness in the ESI process though the response…
Informatics: The use of LIMS in the management of translational research and pilot manufacturing operations
22 October 2013 | By Diana Russom (Department of Information Technology Systems, Beckman Research Institute of the City of Hope) / Amira Ahmed and Nancy Gonzalez (Laboratory for Cellular Medicine, Beckman Research Institute of the City of Hope) / David L. DiGiusto (Laboratory for Cellular Medicine and Department of Virology, Beckman Research Institute of the City of Hope)
The volume of data generated in modern medical research centres is growing exponentially and becoming more diverse as advancements in automation and biotechnology transform the basic operations of these laboratories and clinics. Patient care and laboratory instrumentation generate data at a rate that rapidly outpaces the ability to track and…
Biomarkers for cancer treatment
22 October 2013 | By Amancio Carnero, Instituto de Biomedicina de Sevilla, Consejo Superior de Investigaciones Científicas
There is an urgent need to predict which treatment will report the most benefit to a patient with cancer. To that end, scientists are exploring any possible biomolecule in the organism that can mark each individual for its adequate treatment. If achieved, it will open a personalised medicine era.
Cell-based assays for protein-protein interactions
22 October 2013 | By Mark Wade, Center for Genomic Science of IIT@SEMM
Protein-protein interactions (PPI) form the backbone of all cellular signalling networks, and aberrant PPI contribute to the pathology of several diseases. Thus, strategies to identify PPI modulators are expected to be therapeutically beneficial. However, there are very few examples of clinically approved PPI modulators, reflecting the difficulties of identifying effective…
Towards the real application of rapid microbiological methods in developing countries
22 October 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries
Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still…
Issue #4 2013 – Digital edition
Read the free digital version of the August / September edition of European Pharmaceutical Review magazine...
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...
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…
