Issue #3 2015 – Digital edition
In Issue #3 2015: Regulatory Insight, Microfluidics, PCR in-depth focus, Drug Delivery, Content Uniformity, HPLC, Microbiology in-depth focus, NMR, PAT and much more...
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In Issue #3 2015: Regulatory Insight, Microfluidics, PCR in-depth focus, Drug Delivery, Content Uniformity, HPLC, Microbiology in-depth focus, NMR, PAT and much more...
In this Microbiology In-Depth Focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable...
In this PCR in-depth focus: Mikael Kubista from TATAA Biocenter addresses biological heterogeneity with single cell profiling, a look at quantitative PCR in the assessment of novel hepatic cell models, plus Q&A with Bio-Rad’s Javier Alba...
Maintaining the security of the supply chain for drug products is a significant responsibility to ensure the sustained availability of safe medicines...
3 July 2015 | By Sir Andrew Dillon, Chief Executive, National Institute for Health and Care Excellence
Without constantly examining the systems that underpin what we as an organisation do, opportunities will be missed and performance will stagnate...
3 July 2015 | By Laura A. Filla and James L. Edwards, Saint Louis University
Microfluidic devices (MFDs) have recently become popular as cell culture platforms for metabolomics due to reduced reagent requirements and the feasibility of flow-based studies. Such devices have the potential to transform pharmaceutical research by providing an online approach to high-throughput screening which can be coupled with a variety of analysis…
3 July 2015 | By Anita Umerska, University of Anger and Lidia Tajber, Trinity College Dublin
Polyelectrolyte complexes at the nanoscale (polyelectrolyte complex nanoparticles; PECNs) can be harnessed as drug delivery systems for a range of low molecular weight drugs as well as peptides and proteins. The mild method of manufacture of PECNs results in the protection of the loaded bioactive and the choice of polyions…
3 July 2015 | By Julien Villaumié and Hilary Jeffreys, Actavis
All regulatory agencies require that manufacturers accurately determine the amount of drug in a medicinal product so that the product can be deemed fit for patients. This forms part of batch release testing performed by Quality Control (QC) laboratories. The drug assay and/or content uniformity of the dosage units is…
3 July 2015 | By David P. Elder, Phil Borman and George Okafo - GlaxoSmithKline
The most commonly used analytical technique for the testing of drug molecules is reversed-phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV)/visible detection. However, one of the biggest constraints affecting UV/visible detectors is their inability to generate adequate sensitivity for analytes lacking a suitable UV chromophore.
In an interview with European Pharmaceutical Review, Gilles Goy, Operational Manager of the European Endotoxin and Microbial Detection Contract Staff Laboratory, Charles River, discusses the company’s Accugenix® AccuPRO-ID® service...
3 July 2015 | By Patrick Giraudeau, University of Nantes
Nuclear magnetic resonance (NMR) spectrometry is a major quantitative tool in pharmaceutical analysis, owing to its extremely high accuracy. However, absolute quantification in complex mixtures is often hampered by spectral overlap which considerably reduces the quantitative performance of NMR.
Perceptive Engineering discusses a two year collaborative R&D project it undertook to address challenges associated with the new generation of reactor systems used in production...
3 July 2015 | By Payal Roychoudhury, PhD, formerly AstraZeneca
The past decade has been a period of unparalleled change and development in the fermentation industry. As the nature of this industry evolves, and in particular, with the increasing prominence of the new biopharmaceuticals (therapeutic proteins, diagnostic enzymes and monoclonal antibodies) the need for effective bioprocess monitoring grows in importance1.