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Ultrafiltration of a bacterial immunomodulator for pharmaceutic use – experiment and design,

Domenii publicaţii > Stiinte ingineresti + Tipuri publicaţii > Articol în volumul unei conferinţe

Autori: Camelia Ungureanu, R. Dima, A.A. Chirvase, O. Muntean, N. Radu, A. Onu, A. Salageanu

Editorial: 7th European Symposium on Biochemical Engineering Science, p.193, 2008.

Rezumat:

Objective
The paper presents the experimental research to redesign the separation stage of a bacterial immunomodulator of pharmaceutical use, to be integrated into the GMP (Good Manufacturing Practice) small scale bioproduct manufacture aseptic, closed flow. It is to study: the separation characteristics for each technological operation, the membrane regeneration capacity and to evaluate: the needed membrane aria and the period of working time for a culture volume of 60 L to enter the separation stage.
Experimental part
The experiments by tangential flow filtration comprising three main phase operations: (a) bacterial cells’ separation from culture broth, (b) acetone treated cells filtration and (c) ethanol extract separation, were made on a Sartorius module with a polysulphone membrane area of 75 cm2 and a pore diameter of 0, 22 μm, with retentate total recirculation. After each main operation there were secondary operations meaning the product concentrate washing with water and the membrane regeneration with water, H2SO4 2, 5% N and NaOH 1N.
Results
The study was performed based on the hypothesis that permeate experimental flow behavior are reproducible from lab (4, 5 L) to pilot scale (60 L). (a) Permeate medium flow of 300-400 L/m2h and duration of 59% from the 3 main operations’ total duration for pfeed= 1,5 bar, suspension periodic addition and water wash phase; (b) Permeate medium flow of 750 L/m2h for same pfeed and water wash with duration of 33% from the considered total duration; (c) Permeate medium flow of 3200 L/m2h for same pfeed and water wash with duration of 8% from the same total duration.
Conclusions
The preliminary results, to be checked in further experiments, indicate the determinative secondary operation for the membrane area evaluation is the membrane water washing in the operation (a). One can consequently consider a membrane separation area of 0, 26 m2 for 60 L culture broth coming from the discontinuous bioprocessing stage and total separation duration including membrane regeneration of 5 h. The membrane regeneration became easier as procedure and duration when passing through operations (a), (b), and (c).

Cuvinte cheie: ultrafiltrare, GMP // ultrafiltration, GMP