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MIQE compliance in expression profiling and clinical biomarker discovery
MIQE compliance in expression profiling and clinical biomarker discovery

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
Designing a novel continuous manufacturing plant with superior monitoring and control

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
To float or not to float

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…

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...

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
RMM In-Depth Focus 2015

RMM: In-Depth Focus 2015

22 October 2015 | By

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...

David Elder
David Elder

Foreword: Importation testing: an unnecessary burden on industry?

22 October 2015 | By ,

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
New third-party audit scheme for excipient suppliers

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 manufacturing in the pharma industry – an unstoppable trend?
Continuous manufacturing in the pharma industry – an unstoppable trend?

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…

Improving solubility with promiscuous multi-component drug crystals
Improving solubility with promiscuous multi-component drug crystals

Improving solubility with promiscuous multi-component drug crystals

22 October 2015 | By Masataka Ito, Kiyohiko Sugano and Katsuhide Terada Faculty of Pharmaceutical Sciences, Toho University

The physicochemical properties of active pharmaceutical ingredients (APIs) are critical to the success of drug development. Most of the APIs in oral solid dosage forms are contained as drug crystals.