This multiauthor review article aims to bring readers up to date with some of the current trends in the field of process analytical technology (PAT) by summarizing each aspect of the subject (sensor development, PAT based process monitoring and control methods) and presenting applications both in industrial laboratories and in manufacture e.g. at GSK, AstraZeneca and Roche. Furthermore, the paper discusses the PAT paradigm from the regulatory science perspective. Given the multidisciplinary nature of PAT, such an endeavour would be almost impossible for a single author, so the concept of a multiauthor review was born. Each section of the multiauthor review has been written by a single expert or group of experts with the aim to report on its own research results. This paper also serves as a comprehensive source of information on PAT topics for the novice reader.

Emulsions find a wide range of application in industry and daily life. In the pharmaceutical industry lipophilic active ingredients are often formulated in the disperse phase of oil-in-water emulsions. Milk, butter, and margarine are examples of emulsions in daily life. In the metal processing industry emulsions are used in the form of coolants. Emulsions can be produced with different systems. In the following, the process of high-pressure homogenization is briefly compared to other common mechanical emulsification systems. To facilitate the selection of an emulsification system, the influence of the most important parameters of the emulsion formulation on the resulting mean droplet diameter in the most prevalent continuous emulsification systems is outlined. Subsequently, the most common high-pressure homogenization systems are discussed in detail. On the basis of data from the literature and own experimental results the described high-pressure homogenization systems will be compared regarding their attainable mean droplet diameter. It shows that homogenizers with a relatively simple geometry like the patented ªcombined orifice valveº (Kombi-Blende) attain the smallest mean droplet diameters. The advantage of the ªcombined orifice valveº compared to other high-pressure homogenization systems is not more efficient droplet disruption but rather more efficient droplet stabilization against coalescence immediately after the droplet breakup. The greatest research potential concerning the development of new high-pressure homogenization systems is still to be seen in improvements of droplet stabilization, i.e., the reduction of coalescence.

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Additives have a great effect on the crystal morphology of organic compounds. The molecular modeling techniques were applied to predict the morphological modifications induced by additives. Besides molecular modeling software additionally some simulation approaches are needed. The build-in and the surface docking approaches were applied to some host-additive-systems. It will be presented here that the suitability of these two approaches depends on the degree of anisotropy of the intermolecular bonding of the host substance. A procedure on how to choose an appropriate prediction approach for the individual crystal systems on investigation is suggested.

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Emulsions now find a wide range of applications in industry and daily life. In the pharmaceutical industry lipophilic active ingredients as well as many nutritional products such as vitamins are often formulated in the dispersed phase of oil-in-water emulsions. Emulsions can be produced with different mechanical emulsification techniques. In the following review, the process of rotor-stator systems and disc systems are compared to other popular mechanical emulsification systems. On the basis of experimental results from the authors' laboratory, a discontinuous gear-rim dispersing system, discontinuous disc system, and a continuous high pressure system are compared with regard to their attainable mean droplet diameter and drop size distribution in an oil-in-water emulsion. It can be shown that dissolver discs with a very simple geometry attain very small mean droplet diameters and a very narrow droplet size distribution, comparable to the emulsions obtained with established rotorstator systems such as gear-rim dispersers.

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