Issue #6 2015 – Digital edition
In digital version of Issue #6 2015: Microbiology, Screening, PCR, Continuous Manufacturing, PAT, Regulation, and much more...
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Articles
Application Notes & Whitepapers supplement 2015
Our Application Notes & Whitepapers supplement covers a wide variety of applications, from NMR, biosensors, Raman spectroscopy and QC to hot-stage microscopy...
Screening: In-Depth Focus 2015
6 January 2016 | By Caroline Richards
In this Screening In-depth Focus: High-content screening accelerates discovery rates in the life sciences; Phenotypic screening using 3D tissue culture and whole animal assays; Screening Roundtable...
PAT In-Depth Focus 2015
Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...
Use of the ‘purge tool’ in assessing mutagenic impurities
6 January 2016 | By Dave Elder, GlaxoSmithKline and JPAG
The International Conference on Harmonization M7 text provides guidance on establishing acceptable levels of mutagenic impurities (MIs) . It also outlines the safety and quality risk management processes that manufacturers need to undertake to control MIs that may potentially affect the drug substance or drug product. Over the past decade,…
The limitations of the colony-forming unit in microbiology
6 January 2016 | By Tony Cundell, Microbiological Consulting LLC
The recent revision to USP General Informational Chapter Validation of Alternative Microbiological Methods that became official on December 1, 2015 contained a section discussing the limitations of the colony-forming unit (CFU) in terms of enumerating only those microorganisms that readily grow on solid microbiological media. The section highlights its inappropriateness…
MIQE compliance in expression profiling and clinical biomarker discovery
6 January 2016 | By Irmgard Riedmaier, Melanie Spornraft, Benedikt Kirchner and Michael W. Pfaffl, Technical University of Munich
Molecular diagnostics and biomarker discovery are gaining increasing attraction in clinical research. This includes all fields of diagnostics, such as risk assessment, disease prognosis, treatment prediction and drug application success control. The detection of molecular clinical biomarkers is very widespread and can be developed on various molecular levels, like the…
Designing a novel continuous manufacturing plant with superior monitoring and control
6 January 2016 | By Ravendra Singh, Jun Zhang, Marianthi Ierapetritou and Rohit Ramachandran, The State University of New Jersey
There is a growing interest in manufacturing the pharmaceutical product continuously . Along with other advantages , it provides an appropriate platform to implement suitable monitoring and control architecture, to improve the product quality and minimise product rejection and operating expenses. Continuous pharmaceutical manufacturing can be also considered as a…
To float or not to float?
6 January 2016 | By Sue Staunton, James Cowper Kreston
For many years, global markets had focused their attention on traditional sectors such as natural resources rather than on life science companies, so initial public offerings (IPOs) for such companies were uncommon. The past few years have, however, seen a sea-change and life science companies – from biotech to medical…
An interview with Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk
Caroline Richards, Editor of European Pharmaceutical Review, asks Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk, to provide his insights on the microbial testing industry...
The universal flu vaccine race
5 January 2016 | By Victoria White, European Pharmaceutical Review
A number of pharmaceutical companies see great potential in a universal flu vaccine, each hoping they will be the first to gain regulatory approval of their candidates. European Pharmaceutical Review spoke with Gregory Stoloff, CEO of one such company, SEEK, to find out more...
More pharma M&A to come?
25 November 2015 | By Garry White, Chief Investment Commentator, Charles Stanley
Viagra maker Pfizer announced on Monday that it would purchase Allergan, the Irish maker of Botox, for about $160bn – the biggest deal ever in the healthcare sector. Could more mega-mergers be in prospect?
Immigration strategies for effectively relocating to the US
6 November 2015 | By Ashley Puscas, Associate Attorney at Laura Devine Attorneys
In our globalised economy, it is more common than ever to see pharma companies expanding to establish a presence in multiple markets. Here Ashley Puscas discusses the immigration pathways for pharma seeking to relocate or expand in the US...
Issue #5 2015 – Digital edition
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
Cyber security in pharmaceuticals
22 October 2015 | By Caroline Rivett and Dr Cornelius Namiluko at KPMG
Dr Cornelius Namiluko and Caroline Rivett discuss cyber security in the pharmaceutical industry and the approaches companies can take to address the risk of a cyber attack...
