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4 January 2018 | By Dr Sarfaraz K Niazi - Karyo Biologics
Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five. The FDA, however, since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2009,2 has licensed six products under PHS 351(k) of the Public Health Service (PHS) Act; approved one product under…
3 January 2018 | By Dave Elder, Gene Pacowski, Peter Nelson, Stephen Tindal
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to…
2 January 2018 | By Jos Corver, Pieter-Jan Van Bockstal, Thomas De Beer
Among the list of over 300 FDA and EMA approved biopharmaceutical products, around 50% are freeze-dried – indicating that freeze-drying is the preferred way of stabilising biopharmaceutical drug products that are unstable in aqueous solution, despite the high cost and long processing time linked to this manufacturing technique.1,2
2 January 2018 | By Henry Havel
At least some degree of solubility in water is necessary for active ingredients in pharmaceutical products to be effective in vivo. However, as efforts to discover and synthesise new active ingredients are pursued by industrial and academic medicinal chemists, achieving sufficient aqueous solubility can often be a significant limitation to…
2 January 2018 | By David Lovett, Furqan Tahir
Hot melt extrusion (HME), a manufacturing technique traditionally used in the plastic and food industries, is now attracting significant interest from the pharmaceutical manufacturing sector. This is primarily because HME enables the continuous manufacture of a wide variety of dosage formulations, including solid dose form, which is of particular importance…
2 January 2018 | By Christof Hohne
Christof Hohne, partner at patent law firm EIP, discusses second medical use claims and compulsory licences...
21 December 2017 | By European Pharmaceutical Review
European Pharmaceutical Review has brought you the most up-to-date and relevant pharmaceutical science for the past 21 years. This anniversary supplement brings you a selection of topical views from across the industry, reviewing progress over that time, as well as looking to the future.
20 December 2017 | By European Pharmaceutical Review
This In-Depth Focus examines water solubility for active ingredients, hot melt extrusion and designing appropriate non-clinical safety studies.
19 December 2017 | By Katheryn Shea, Maria Thompson
On 30 March 2019 the UK is set to leave the European Union (EU), a process that has become popularly known as Brexit. One little talked-about aspect of this move in the mainstream media is the impact it will have on the British life science community. Researchers and industry leaders…
18 December 2017 | By European Pharmaceutical Review
This In-Depth Focus looks at photobleaching profile of Raman peaks and surface-enhanced Raman spectroscopic sensing of glucose.
18 December 2017 | By Chris Edlin, Darren Whitaker
Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an…
15 December 2017 | By Laila Al-qarn, Zafar Iqbal
The small normal Raman cross-section of glucose is a major challenge in its detection by surface enhanced Raman spectroscopy (SERS) for medical applications, such as blood glucose level monitoring of diabetic patients and evaluation of patients with other medical conditions, since glucose is a marker for many human diseases. Here…
15 December 2017 | By Derya Cebeci-Maltaş, Dor Ben-Amotz, Md Anik Alam, Ping Wang, Rodolfo Pinal
Laser-induced fluorescence is the most common source of interfering baseline signal encountered in Raman measurements. It shows itself as a slowly changing background in a spectrum. One of the challenges in the successful use of Raman spectroscopy is to extract Raman signatures from this, orders of magnitude stronger, broadband fluorescence…
15 December 2017 | By Arathi Kizhedath, Jarka Glassey
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
15 December 2017 | By David Keller
Designing appropriate non-clinical safety studies requires thoughtful, and sometimes experimental, consideration of the delivery methodology for the therapeutic. The choice of formulation affects drug release and absorption and has a direct impact on the pharmacokinetic profile and associated response of the model system. The formulation should be compatible with the…
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