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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
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...
RMM: In-Depth Focus 2015
In this RMM In-Depth Focus: Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable...
Raman Spectroscopy: In-Depth Focus 2015
In this Raman Spectroscopy In-Depth Focus: Identification of counterfeit drugs using dual laser handheld Raman; Low-frequency shift Raman spectroscopy of pharmaceutical respirable powders; Raman Roundtable...
Foreword: Importation testing: an unnecessary burden on industry?
One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised…
New third-party audit scheme for excipient suppliers
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
Continuous flow processing in the pharma industry – an unstoppable trend?
22 October 2015 | By Bernhard Gutmann and Christian Oliver Kappe, University of Graz
Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry…
