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Manual de prezentare biotehnologii avansate de preparare a unor produse biologice terapeutice de uz uman şi de diagnostic cu integrarea unor metode optimizate de asigurare a calitãtii şi de control, în conformitate cu standardele şi normele europene

Domenii publicaţii > Ştiinţe medicale + Tipuri publicaţii > Carte

Autori: Camelia Ungureanu, A. A. Chirvase, N. Radu, A. Onu, A. Sãlãgeanu, I. Stoica, M. Hilebrand, F. Antohe

Editorial: ed. Politehnica Press, Manual de prezentare biotehnologii avansate de preparare a unor produse biologice terapeutice de uz uman şi de diagnostic cu integrarea unor metode optimizate de asigurare a calitãtii şi de control, în conformitate cu standardele şi normele europene, -, p.116 pagini, 2008.

Rezumat:

Chapter 1 highlights the current state of the art regarding the content and the application of the Good Manufacturing Practice rules for the manufacture of the therapeutic bioproducts of human use. They must be also observed by the romanian biopharmaceuticals companies after the accession into the European Union. These rules are to be applied to all stages of the technological flow, and they impose the need of research in connection with: (a) the quality of water (pharmaceutical degree characteristics), of air and steam; (b) the main characteristics of the bioreactor and of the bioprocessing line; (c) the recommended modes of operation; (d) finally the separation-purification methods and working procedures.
Chapter 2 presents the solution for the integrated technological flow; the initial technological flow was modified so that it comprises isolated and closed operations done in technological installations realised in accordance with the CIP (cleaning in place) and SIP (sterilising in place) procedures needs.
Chapter 3 develops the characterization of the microbial transformation by presenting the culture medium composition analysis, the study of the microbial growth kinetics in the optimized discontinuous bioprocessing flow and the experimental determination of the mass transfer parameters for gas to liquid phase. Also an alternative to the repeated batch operating mode is proposed, namely the application of single use bioreactors.
Chapter 4 deals with the optimization of the imunomodulator bioproduct’ separation and concentration phase in agreement with the same rules of Good Manufacturing Practice. The replacement of the centrifugation operation with the tangential filtration and the determination of recommended working conditions and also the replacement of acetone inactivation with heat inactivation are original contributions brought to the initial technological flow.
Chapter 5 presents the general conclusions of the performed theoretical and experimental study.

Cuvinte cheie: biotehnologie, produse terapeutice, GMP // biotechnology, biotherapeutic products, GMP