Pharmaceutical science & technology today最新文献

Monitor provides an insight into the latest developments in pharmaceutical science and technology through brief synopses of recent presentations, publications and patents, and expert commentaries on the latest technologies. There are two sections: Progress summarizes the latest developments in pharmaceutical process technology, formulation, analytical technology, sterilization, controlled drug delivery systems and regulatory issues; Profiles offers expert commentary on emerging technologies, novel processes and strategic, organizational and logistic issues underlying pharmaceutical R&D.

Recent improvements in instrument hardware, experimental design and data processing have made it possible to use surface plasmon resonance (SPR) biosensor technology in the discovery and development of small-molecule drugs. The key features of SPR biosensors (i.e. real-time binding analysis and lack of labeling requirements) make this technology suitable for a wide range of applications. Current instruments have a throughput of ∼100–400 assays per day, providing a complement to secondary screening. The ability to collect kinetic data on compounds binding to therapeutic targets yields new information for lead optimization. Small-molecule analysis and emerging applications in the areas of ADME (adsorption, distribution, metabolism and excretion) and proteomics have SPR biosensors poised to play a significant role in the pharmaceutical industry.

The skin represents an extraordinary evolutionary feat. Not only does it physically encapsulate the organism and provide a multifunctional interface between us and our surroundings, but it is perpetually engaged in the assembly of a highly efficient homeostatic barrier to the outward loss of water¹. In so doing, it furnishes a membrane that is equally adept at limiting molecular transport both from and into the body. Overcoming this barrier function then, for the purpose of transdermal drug delivery, has been a necessarily challenging task for the pharmaceutical scientist, and one that boasts significant progress.

Can the pharmaceutical industry learn anything from other powder processing industries? Although essential regulatory processes have ensured that the pharmaceutical industry is a leader in quality assurance, they have also led to a conservative approach to process technology. Conservatism is advantageous when the dosage form and profit margins are stable; however, for most other industries, form, price and quality of product are all subject to fickle customer requirements. Other powder industries have used a sequential questioning approach to elicit new technical responses to change. Perhaps the time is ripe for this to be introduced to the pharmaceutical industry?

Antibody internalization is required for the success of many targeted therapeutics, such as immunotoxins, immunoliposomes, antibody–drug conjugates and for the targeted delivery of genes or viral DNA into cells. Recently, it has become possible to directly select antibody fragments from phage display libraries for internalization into mammalian cells. Here we review the therapeutic applications of internalized antibodies and describe how phage display enables the isolation of internalizing antibodies to novel or known targets.

A new and forward-looking way of running process R&D is introduced that integrates this core business in an efficient manner into the network of activities in different disciplines, which constitute the arena for the development of pharmaceutical products. The interfaces with surrounding areas are discussed in addition to the novel organizational principles implemented in process R&D and the workflow emanating from this. Furthermore, the Tollgate model used to keep track of the progress in a project and the pre-study concept are presented in detail. Finally, the main differences between operating modes in the past and in the future are highlighted.

The mucosal epithelium of the upper respiratory tract constitutes an effective physical barrier to many pathogens. Its mucosal-associated lymphoid tissue is of particular importance for the protection and integrity of mucosal surfaces and the body’s interior. Understanding the factors that influence the induction and regulation of mucosal immune responses will facilitate the design of vaccines capable of eliciting the appropriate type of protective immune response.