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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
Issue #3 2014 – Digital edition
In Issue #3 2014: Pharmaceutical freeze-drying, Self-amplifying mRNA vaccines, Polymorph myths, Microbiology focus, NMR for isotope profiling, Manufacturing with QbD 2.0, Single-cell mRNA-Sequencing, qPCR focus, Powder Flow...
Microbiology: In-Depth Focus 2014
In this free-to-view in-depth focus: How to deal with non-sterile results in aseptic processing, Risk Profiling and Proactive Response (RPPR) to Bio-contamination in GMP classified and controlled areas, Microbiology Roundtable...
qPCR: In-Depth Focus 2014
In this free-to-view in-depth focus: Prime time for qPCR – raising the quality bar, PCR to diagnose infectious disease, plus qPCR Roundtable...
What does quality mean to you?
An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the…
Techniques to preserve product quality in pharmaceutical freeze drying
In a pharmaceutical freeze drying process, it is mandatory to preserve product quality. This means that for a given formulation that has to be freeze dried, the temperature has to remain below a limit value corresponding to the eutectic temperature for a product that crystallises after freezing, with the goal…
Using self-amplifying mRNA vaccines to facilitate a rapid response to pandemic influenza
Influenza viruses are members of the Orthomyxoviridae family and are a major cause of respiratory tract disease in humans and many animal species. There are three influenza virus types that cause human disease: A, B and C. Type A are further subtyped based on the antigenicity of the hemagglutinin (HA)…
Polymorphism – Polymorph myths and misperceptions
The past quarter of a century has seen an enormous increase in the number of papers on the behaviour of the organic solid state, particularly those concerning pharmaceutical polymorphs and solvates. High profile patent cases (ranitidine hydrochloride, paroxetine hydrochloride) combined with product polymorph issues (ritonavir), all of which have carried…
NMR – Recent developments for isotope profiling
Fraudulent misrepresentation, substitution or imitation of premium products has always been a problem for both the regulatory authorities and the pharmaceutical industry. The task of finding and preventing counterfeit products is particularly challenging1,2. Several analytical techniques are available to help characterise pharmaceutical compounds: physical profile; X-ray diffraction; infrared spectroscopy; mass…
Pharma development and manufacturing with QbD 2.0
3 July 2014 | By José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd
Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them.
Understanding early mouse embryonic development using single-cell mRNA Sequencing
3 July 2014 | By René Dirks and Hendrik Marks, Department of Molecular Biology, Radboud Institute for Molecular Life Sciences (RIMLS)
Biomedical research often involves the use of cell lines that can be cultured in a laboratory. Individual cells within such cell lines often share a similar morphology. A remarkable exception are in vitro cultured mouse Embryonic Stem Cells (mESCs) – pluripotent cells derived from the blastocyst stage of the mouse…
Pharmaceutical powders characterisation – the need for a multivariate approach
3 July 2014 | By Brian Armstrong and Katrina Brockbank, Freeman Technology
Powders and bulk materials are widely used in industry as raw materials, intermediates and finished products. Indeed, over 60% of the value of pharmaceutical sales worldwide is accounted for by powder formulations, typically as tablet/capsule/sachet or in the form of an inhalable powder. Whilst they are used extensively, they are…
Issue #2 2014 – Digital edition
In Issue #2 2014: Mass Spectrometry and Stem Cells in-depth focuses, Hot Melt Extrusion, PAT, Excipients, Microbiology plus much more...
Stem Cells: In-Depth Focus 2014
In this free-to-view Stem Cells In-Depth Focus: Mesenchymal stem cells in cancer therapy - our chance to take charge, and Ovarian cancer stem cells - an essential target for durable remission...
Mass Spectrometry: In-Depth Focus 2014
In this free-to-view Mass Spectrometry In-Depth Focus: Some tricks and tools for structural characterisation of natural products using Electrospray mass spectrometry, Mass spectrometry in the biopharmaceutical industry: from the mundane to the cutting edge, and Mass Spectrometry roundtable...
Is risk in the eye of the beholder?
An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation1. In this context, risk is defined as the combination of the probability of occurrence of harm (or unwanted outcome) and the…
