Abstract
The development of new biopharmaceuticals for use in new therapies is one of the major drawbacks of the pharmaceutical industry, mainly with the increase of human resistence against the conventional pharmaceutical compounds. In fact, the pharmaceutical industry is facing now the generic drugs growth and, with it, there is a crucial need to minimize the operational costs, mainly enclosing the production and purification steps. This project proposes the use of an alternative and more sustainable purification methodology to separate and isolate an anti-leukemia biopharmaceutical, the L-Asparaginase, from fermented broth. In this context, aqueous two-phase systems (ATPS) composed of Ionic Liquids (ILs) and polymers (polymer-IL, polymer-salt-IL) will be applied. In the first stage of the project, the ATPS will be characterized, with the phase diagrams determination and the respective characterization of their principal thermodynamic properties, as well the developind of simulation models to predict their formation. The second stage contemplates the study of the activity and stability of the commercial ASPase, followed by its extraction at a lab-scale. Having into account the best results obtained in the optimization step described by the second step, in the third stage, the ASPase obtained from the fermented broth of recombinant Pichia pastoris will be purified and isolated from the fermented media, and the respective design and scale-up of a pilot-plant of the biopharmaceutical purification will be developed in the last stage. Aiming a future industrial application, the ATPS scale-up will be developed for batch and continuous processes. Summing up, it will be expected the development and study the industrial applicability, of new methodologies, capable of to promote the purification of diverse biopharmaceutical compounds with pharmaceutical, industrial and economical high-value, using more sustainable and inert processes, and exhibiting higher rates of selectivity and purification yields. (AU)
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