Naslov
Manufacturing and down scaling process for a virus-inactivated pooled human plasma

Autori
Morfeld, Frank ; Schütz, R ; Josic, Djuro ; Schwinn, H

Izvornik
Drugs made in Germany (0012-6683) 58 (1996); 433-435

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Down Scaling ; Virus-inactivated ; Human Plasma

Sažetak
In order to eliminate any risk of transfusion relevant viruses in recipients of fresh frozen plasma, a manufacturing process for a virus-inactivated (v.i.) pooled human plasma has been developed. The process comprises a filtration step, subsequent to pooling, a treatment with a tri-n-butylphosphate (TnBP)/Triton X-100 mixture, effecting the inactivation of enveloped viruses, an extraction step with castor oil aiming the reduction of non-enveloped viruses, and a hydrophobic resin chromatography, rendering the plasma free from virucidic agents. According to the Guidelines of the European Committee for Proprietary Medicinal Products (CPMP), the virus safety of a pharmaceutical product derived from human blood has to be documented by a socalled 'down scaling protocol', to be established prior to the subsequently performed experiments on virus validation. For this reason, the manufacturing process for the virus inactivation was modelled down to a scale of 1:100 to 1:700 and the resulting analytical figures were compared with those ones of the original large scale process. No significant differences were found, thus it was concluded both scales to be equivalent. Given so, the established 'down scaling protocol' can be used for any subsequent experiments dedicated to virus validation.

Izvorni jezik
Engleski

Znanstvena područja
Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

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