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...
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Articles
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…
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.
Meeting biopharmaceutical analytical requirements for subvisible particle sizing and counting
22 October 2015 | By John Carpenter, University of Colorado / Amber Haynes, Fradkin KBI Biopharma / Christina Vessely, Biologics Consulting Group Inc.
Quantifying and sizing subvisible particles in biopharmaceutical products are crucial aspects of formulation development, stability studies, process development, product release and extended characterisation of the final drug product.
Dynamic vapour sorption of freeze-dried pharmaceuticals
22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen
Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…
2015 Excellence in ADHD Patient Group Awards: Patient advocacy at Shire
20 October 2015 | By Victoria White
In the run up to ADHD Awareness Week, European Pharmaceutical Review spoke with Tom Croce, Head of Global Patient Advocacy at Shire, to find out more about the awards and what makes Shire a 'patient-centric' company...
Counterfeit medicines and the need for a global approach
16 October 2015 | By David Shore, Pfizer
Counterfeit medicines pose a serious risk to public health around the world. The trade in fake drugs is considerable; according to Pfizer’s own company records, more than 200 million counterfeit doses of Pfizer product have been intercepted since 2004. Meanwhile, the issue of counterfeits has no single or simple solution…
Issue #4 2015 – Digital edition
In Issue #4 2015: NGS, Informatics, Spray Drying, Excipients, Rapid Methods, NIR, PAT, Regulatory Insight and much more...
NIR In-Depth Focus 2015
In this NIR In-Depth Focus: Challenges with NIR reflectance measurements of solid pharmaceuticals, Application of NIR spectroscopy in linking velocity profiles of a binary granular system...
Informatics In-Depth Focus 2015
In this Informatics In-Depth Focus: Informatics in 2025, Methods for the detection of drug-drug interactions in text & Computational approaches to mutagenicity assessments of impurities: in silico methods...
