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manufacturing of recombinant therapeutic proteins offers several advantages over batch processing: improved and consistent product quality, reduced equipment size, streamlined processes, low process cycle times, reduced capital and operating cost, increased

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Abstract  

Alginate has been established as a very versatile material in the preparation of hydrogel capsules for trapping therapeutic biomolecules and cells. The physico-chemical properties, the mechanism and the processing of gel formation are now well established. In the frame of a project aiming at the exploitation of encapsulation of therapeutic proteins in alginate gel particles, the procedure of preparation, characterization, gel-drying and re-hydrating has been explored for the shelf-life of the encapsulated biomolecules. Here, the results of a calorimetric study on the freezing and dehydration process of alginate micro-capsules is presented. The work aims at the description of water state(s) and its removal under “controlled conditions” in the presence of bioprotectant sugars.

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Abstract

Cell derived extracellular vesicles are submicron structures surrounded by phospholipid bilayer and released by both prokaryotic and eukaryotic cells. The sizes of these vesicles roughly fall into the size ranges of microbes, and they represent efficient delivery platforms targeting complex molecular information to professional antigen presenting cells. Critical roles of these naturally formulated units of information have been described in many physiological and pathological processes. Extracellular vesicles are not only potential biomarkers and possible pathogenic factors in numerous diseases, but they are also considered as emerging therapeutic targets and therapeutic vehicles. Strikingly, current drug delivery systems, designed to convey therapeutic proteins and peptides (such as liposomes), show many similarities to extracellular vesicles. Here we review some aspects of therapeutic implementation of natural, cell-derived extracellular vesicles in human diseases. Exploration of molecular and functional details of extracellular vesicle release and action may provide important lessons for the design of future drug delivery systems.

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. & Labrou, N.E. (2006): Development of an aqueous two-phase partitioning system for fractionating therapeutic proteins from tobacco extract. J. Chromat. A , 1128 , 114–124. Labrou N

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Mahmood, I., Green, M. D.: Pharmacokinetic and pharmacodynamic considerations in the development of therapeutic proteins. Clin. Pharmacokinet., 2005, 44 , 331–347. Green M. D

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. H Schellekens 2002 Immunogenicity of therapeutic proteins: clinical implications and future prospects Clin Ther 24 1720 1740

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tolerance to therapeutic proteins . PLoS One . 2010 ; 5 : e15252 . 10.1371/journal.pone.0015252 12. Haile , LA Puig , M

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