In July, GlaxoSmithKline (GSK) transferred its research operations in Verona, Italy to Aptuit, a global drug development organization based in Greenwich, Connecticut. Beyond the significance of the transaction itself to each of these businesses, the structure of this deal is indicative of a broader trend of Big Pharma taking steps to reshape their approach to clinical development...

In recent years it has become more common for companies and universities to produce new technology patents. Indeed university researchers and professors in many countries are encouraged by governments to patent new ideas coming out of their research, and to found start-up companies to commercialise these patents. However, a search of these companies and patents after a gap of several years reveals that many of the patents have been abandoned and the companies have been liquidated. What is the problem here?

At IMM , all development steps required for building a fuel processor have been addressed. Reactor and system design, catalyst development and set-up/testing of complete fuel processors are realised for systems up to 5 kW power output of the corresponding fuel cell. The applications standing behind the development work are manifold. Having demonstrated the feasibility of compact fuel processing, the aspects of future mass production of such devices for consumer applications are discussed...

Glycerol, the main by-product of biodiesel production, has been considered a renewable chemical for large scale production of a new potent fuel-additive, namely solketal tertbutyl ether (STBE). Delta Biovalue BV, a major biodiesel manufacturer in the European Union, Corning Incorporated, a manufacturer of modular Advanced-FlowTM glass reactors and SynBioC, a research group with a long-standing interest and know-how in flow and renewable chemistry have collaborated to develop a new process aimed at performing the transformation of glycerol in STBE under flow conditions. The advantages of the highly engineered Corning reactor system, including: high mixing, heat-exchange efficiencies under corrosive flow conditions with low liquid hold-up and high throughput, allowed the development and the intensification of a two-step process with 83 percent global yield. The final goal of this project is to develop a robust, green and safe process being able to produce ~12,000 t/y STBE

Process technology appears to get increasing attention in the whole process of pharmaceutical development. Although the contribution of an efficient manufacturing process to the success and profit of a large pharmaceutical appears small, this contribution is significant when it comes to sustainable manufacturing. Here an efficient process helps to lower environmental impact at the site of production and allows production beyond the patent life of a product. The design and scale-up of a sustainable process comprises route design, use of state-of the art chemical methods and also state-of-the-art process technology such as continuous manufacturing by intensified processes. DSM has developed a set of competences in these fields. Examples and metrics related to the sustainability of the described processes are given

The use of spray drying in the pharmaceutical industry is growing at a fast pace. The need for robust scale-up methods is essential in order to control critical quality attributes and improve powder properties during drug development. Moreover, poor scale-up is likely to lead to considerable losses of expensive materials. Process understanding and simulation is a very powerful tool to support the scale-up of spray drying processes. A scale-up methodology based on scientific principles is proposed in this study. The method is divided in two steps: thermodynamic and atomization & particle formation...

The increasing pressure to reduce costs in the production of chemicals and pharmaceutical compounds has led to the concept of holistic process intensification. The concept is to find barriers to more efficient production across the manufacturing value chain and reduce them. The utilization of new processing concepts such as the use microscale unit operations with their dramatically enhanced heat and mass transfer characteristics are often required to achieve the required step changes in efficiency. Real-time analysis coupled with these new types of unit operations enables much faster determination of optimized processing parameters. The parameters of the analysis system required for efficient characterization of the operation of these units is described

Patents and data protection of the princeps product are two means used by originator companies to block generics from entering the market. As shown by the European Commission Report of 8 July 2009 relative to the pharmaceutical sector inquiry and focusing on the use of patents by originator companies, many weapons using patents can be deployed both at the stage of acquiring rights and when exercising those right. Similarly, even if Directive 2004/27 has clarified several points relative to data protection, several issues remain, particularly regarding the interpretation of the global MA that holds back the entry of generics. This article intends to provide an overview of the issues regarding patent and data protection while illustrating these issues with recent cases law

When manufacturing highly potent APIs, a great deal of care is necessary to protect operators and the environment, and equipping a facility represents a substantial investment. This article looks at how highly potent APIs are categorised, and the containment and other engineering requirements that have to be put in place to ensure safety

Hexamethylbenzene reacts differently with zirconium and hafnium tetrachloride, affording, for the former, a binuclear molecular complex Zr(η6-Me6C6)Cl2(μ-Cl)3ZrCl3 and for the latter a binuclear ionic complex [Hf(η6-Me6C6)Cl3]+[Hf2Cl9]-. This difference in reactivity is exploited to carry out a two-phase extraction using 1-butyl-3-methylimidazolium tetrachloroaluminate as the ionic liquid phase and a toluene/pentane mixture as the organic phase. This technique presents the potential advantage of recovering of pure zirconium chloride without the formation of highly inert oxides

Potassium-competitive acid blockers (P-CABs) containing an imidazo[1,2-a]pyridine / benzimidazole scaffold, respectively were prepared via asymmetric hydrogenation of aryl ketone intermediates in the presence of RuCl2[(S)-Xyl-P-Phos][(S)-DAIPEN]. The enantioselective synthesis of BYK 405879 was successfully implemented on Kg scale

Two techniques for separation of racemates without aid of external chiral sources are discussed. The techniques are based on the natural occurrence of conglomerates. The first is very well known, namely preferential crystallization. We suggest methods to make conglomerates more accessible in order to improve the attractiveness of this method. The second method is entirely new and involves attrition induced grinding of racemizable conglomerates as solids in contact with solution wherein racemization occurs, with a theoretical 100 percent yield and 100 percent enantiomeric excess. This technique has recently been applied to the synthesis of two popular drugs, Clopidogrel and Naproxen...