No abstract

Knowledge-based development of chromatographic separation processes requires efficient techniques to determine the physicochemical properties of the product and the impurities to be removed. These characterization techniques are usually divided into approaches that determine molecular properties, such as charge, hydrophobicity and size, or molecular interactions with auxiliary materials, commonly in the form of adsorption isotherms. In this study we demonstrate the application of a three-dimensional liquid chromatography approach to a clarified cell homogenate containing a therapeutic enzyme. Each separation dimension determines a molecular property relevant to the chromatographic behavior of each component. Matching of the peaks across the different separation dimensions and against a high-resolution reference chromatogram allows to assign the determined parameters to pseudo-components, allowing to determine the most promising technique for the removal of each impurity. More detailed process design using mechanistic models requires isotherm parameters. For this purpose, the second dimension consists of multiple linear gradient separations on columns in a high-throughput screening compatible format, that allow regression of isotherm parameters with an average standard error of 8%. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1283-1291, 2016.

The broad spectrum of applications of three-dimensional printing (3D printing, 3DP) has attracted the attention of researchers working in diverse fields. In pharmaceutics, the main idea behind 3D printing products is to design and develop delivery systems that are suited to an individual's needs. In this way, the size, appearance, shape, and rate of delivery of a wide array of medicines could be easily adjusted. The aim of this chapter is to provide a compilation of the 3D printing techniques, used for the fabrication of oral drug delivery systems, and review the relevant scientific developments in particular those with modified-release characteristics.