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Much rests on the further development of bioanalytical technologies which allow the highest level of sensitivity on small samples, and robust, high reproducibility across large populations. Johan Devenyns, CEO PharmaFluidics, explains further...
When thinking about the future of the pharmaceutical sector, it can be difficult to pinpoint a specific focus as there are a wide range of challenges that come into consideration across all stages of development and manufacturing. Dr Lynne Murdoch, Business Manager – Microbiology, Wickham Laboratories, considers some key points....
Two years ago, Servier launched an ambitious programme of transformation to adapt to the new reality of the pharmaceutical industry. Olivier Laureau, CEO of Servier and President of the Fondation Internationale de Recherche Servier, explains the initiative and other achievements.
For Pfizer, putting patients first guides its actions, informs its strategic decisions and unifies colleagues in every region and function across the company. Beatriz Faro, Regional President, Internal Medicine, International Developed Markets at Pfizer, explains how the company’s philosophy is taking the business forward...
Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five.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…
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…
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
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…
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…
Christof Hohne, partner at patent law firm EIP, discusses second medical use claims and compulsory licences...
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.
This In-Depth Focus examines water solubility for active ingredients, hot melt extrusion and designing appropriate non-clinical safety studies.
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…
This In-Depth Focus looks at photobleaching profile of Raman peaks and surface-enhanced Raman spectroscopic sensing of glucose.
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…
