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Biotechnologically modified collagenase for the preparation of advanced therapy medicinal products

Identification code: FV20139

Project solution period: 2017-2021

This project is implemented for financial

support from the state budget

through the Ministry of Industry and Trade

The aim of the project is to develop advanced production technologies for highly efficient purification of individual proteases, which are an active part of traditional collagenase preparations. These are prepared by fermentation of Clostridium histolyticum strains and, in addition to collagenases type 1 and 2, also contain undesirable components, including endotoxin, in various proportions. Gradual separation by filtration and high performance liquid chromatography will give pure monocomponent fractions. Furthermore, a modified collagenase with an affinity tag will be produced to facilitate its separation. The separated proteases will be combined as desired. The resulting preparations will serve for effective disintegration of organs and tissues for the preparation of defined cell populations and tissue structures. These are needed today for the preparation of so-called "modern therapy" products, the production process of which requires a declaration of high purity and defined activity of all means used.

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