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Issue 4 2015
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Historically, the regulation and control of medicinal products has relied on national and supranational guidelines covering good manufacturing practice (GMP). However, the quality of these medicinal products can be adversely affected by a lack of adequate control over the myriad activities that occur during the distribution process. In addition, the…
3 September 2015 | By Joseph W. Wragg and Roy Bicknell, University of Birmingham
Over the past decade significant advances have been made in the fields of genomic and transcriptomic profiling, inspired by the advent of next-generation sequencing (NGS). Yet despite the considerable promise of these new technologies, uptake has been slow. The focus of this review is the use of next-generation transcriptomic analysis…
3 September 2015 | By Yin-Chao Tseng, Boehringer Ingelheim
Amorphous solid dispersions (ASDs) are increasingly being used as a means of improving bioavailability of poorly water-soluble compounds in research and development, and spray drying technology has been recognised as one of the useful methods to generate ASDs.
3 September 2015 | By Benjamin K. Hodnett, Anita R. Maguire, Pat J. Guiry, Ake C. Rasmuson, Brian Glennon and Abina M. Crean - SSPC
The Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing, is funded by Science Foundation Ireland (SFI) and Industry, and represents a unique collaboration between 22 industry partners, nine research performing organisations and 12 international academic collaborators. It is a €42 million…
3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC
From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.
3 September 2015 | By Cenk Undey, Tony Wang, Bryan Looze, Yingying Zheng and Myra Coufal - Amgen
Predictive monitoring is a key feature of biopharmaceutical manufacturing; making predictions about the key process end points such as process performance indicators or quality attributes using a process model offers the unique advantages of process improvement and optimisation, and helps give insights into variability.
3 September 2015 | By Jaume Puig-JunoyPompeu, Fabra University / Beatriz G. Lopez-Valcarcel and Santiago Rodríguez-Feijoó, University of Las Palmas de Gran Canaria
The sudden fall of public revenues after the long-lasting economic crisis that began in 2008 has led many public health systems in European countries to cut public health financing through high copayments or coinsurance rates on drug prescriptions dispensed in pharmacies.