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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…

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…

Next-generation transcriptomic analysis in cancer vascular research

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…

Spray Drying: Solving solubility issues with amorphous solid dispersions

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.

The SSPC: leading the way for next-generation medicines manufacture

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…

Rapid methods update: revisions to a United States Pharmacopeia chapter

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.

PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing

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.