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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
Under the microscope with Gareth Jenkins from AMRI
Founded in 1991, AMRI (Albany Molecular Research Inc.) is a contract research and manufacturing organisation, with locations in the US, Europe and Asia. The company provides fully integrated drug discovery, development and manufacturing services to the pharmaceutical and biotechnology industries.
Near Infrared Spectroscopy In-Depth Focus 2013
In this Near Infrared Spectroscopy In-Depth Focus: Validation methodologies of near infrared spectroscopy methods in pharmaceutical applications; Evaluating the influence of hopper geometry on radial and axial concentration profiles in flowing granular mixtures...
Pharmaceutical Manufacturing & Packaging In-Depth Focus 2013
In this Pharmaceutical Manufacturing & Packaging In-Depth Focus: The chemical safety assessment process for extractables and leachables associated with packaged pharmaceutical products; INTERPHEX 2013: Show preview...
Intelligent Process Condition Monitoring for industrial tablet coating operation
18 December 2012 | By Jun Huang, Saly Romero-Torres, Liam Ryan and Mojgan Moshgbar, Pfizer Inc
This paper presents a feasibility study to develop an Intelligent Process Condition Monitoring (IPCM) system for providing a real time ‘health check’ for the tablet coating process in drug product manufacturing. The study fits well under the framework of Intelligent based Manufacturing (IbM) initiated at Pfizer, and intends to move…
Future trends in drug discovery technology
18 December 2012 | By Terry McCann, TJM Consultancy
The average cost to a major pharmaceutical company of developing a new drug is over USD 6 billion1. Herper1 observes that the pharmaceutical industry is gripped by rising failure rates and costs, and suggests that the cost of new drugs will be reduced by new technologies and deeper understanding of…
A new vision of drug discovery and development
18 December 2012 | By D. Lansing Taylor, Director, University of Pittsburgh Drug Discovery Institute and Allegheny Foundation Professor of Computational and Systems Biology, University of Pittsburgh School of Medicine
The pharmaceutical industry has experienced a decade of turbulence driven by the ‘patent cliff’ as major revenue generators are lost to generic status, coupled to the absence of a sustainable pipeline of drug candidates in development that have a good chance of being approved and launched. It is generally agreed…
MS-based methods for detection, quantitation and localisation of pharmaceuticals and metabolites in biological samples
18 December 2012 | By Tyler Greer, Department of Chemistry, University of Wisconsin-Madison and Lingjun Li, Department of Chemistry & School of Pharmacy, University of Wisconsin-Madison
Mass spectrometry is a powerful, multi-faceted technique capable of analysing pharmaceuticals and their metabolites in biological matrices. Although it is more commonly applied to proteins, peptides and lipids, an increasing number of studies use mass spectrometry based techniques to detect, quantitate and localise pharmaceuticals and their metabolites. The availability of…
Found in translation
18 December 2012 | By Theresa LaVallee, Senior Director, Translational Medicine Oncology, MedImmune
The development of biologic therapies has significantly shifted the treatment paradigm in medicine, particularly in oncology. Groundbreaking research over the past 20 years has sparked new ways of thinking about disease pathology and opened the door for novel targeted therapies that have truly revolutionised medical care. In more recent years,…
Putting the ‘fun’ into functional genomics: a review of RNAi genomewide cellular screens
18 December 2012 | By Dr. Stephen Brown, Sheffield RNAi Screening Facility, Biomedical Sciences, University of Sheffield
As RNA interference (RNAi) enters its teenage years from the first critical observations, it has now reached a multi-billion pound industry. There are few research areas that have expanded as quickly and spectacularly as the field of RNAi. The potential of RNAi initially sparked a functional genomics gold rush. Different…
What is label-free screening and why use it in drug discovery?
18 December 2012 | By Matthew A. Cooper and Reena Halai, Institute for Molecular Bioscience, the University of Queensland
In the journey of a molecule from its origins in a compound library to candidate drug status, a large variety of profiling must occur to define activity, selectivity, potency, adverse effects, pharmacology and in vivo efficacy. Advances in biophysical methods that can analyse drug interactions with a molecular target, a…
Drug discovery assays for the histone deacetylase class of enzymes
18 December 2012 | By Sheraz Gul and Gesa Witt, European ScreeningPort GmbH
The histone deacetylase (HDAC) class of enzyme are a group of conserved enzymes known for their ability to remove acetyl groups from lysine residues on histone tails. Since aberrant HDAC enzyme expression is observed in various diseases, there is increasing interest in finding small molecules which function as HDAC enzyme…
Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring
18 December 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used…
RNA quality matters
18 December 2012 | By Mikael Kubista, Jens Björkman, David Svec and Robert Sjöback, TATAA Biocenter
RNA levels can be measured with very high specificity, sensitivity and accuracy with techniques such as real-time quantitative PCR (qPCR), microarray analysis and next generation sequencing. This makes messenger (m) RNAs and potentially microRNAs and other non-coding RNAs popular as biomarkers. But RNA is less stable and more dynamic than…
Under the Microscope: John Comer, Sirius Analytical
18 December 2012 | By Helen Bahia, Editor, European Pharmaceutical Review
John Comer, Chief Scientific Officer at Sirius Analytical, discusses particle size analysis and characterisation. Sirius Analytical was founded in 1989 with the goal to become a world-class manufacturer of innovative instrumentation for chemical analysis. Today, Sirius Analytical makes instruments to measure the physicochemical properties of drugs, specifically pKa, logP, solubility…
Drug Targets In-Depth Focus 2012
In this Drug Targets In-Depth Focus: GPCR allosteric modulation: new opportunities and challenges for drug discovery; Chloride channels and cardiac arrhythmia: novel therapeutic targets?
