Viral inactivation of intramuscular immune serum globulins.
Biologicals
; 28(1): 5-15, 2000 Mar.
Article
en En
| MEDLINE
| ID: mdl-10799050
A new process for the production of intramuscular immunoglobulin products is described which includes viral inactivation through solvent-detergent treatment. Removal of solvent-detergent was accomplished by precipitation, filtration and diafiltration. Process-scale preparations had appropriate antibody potency levels, and improved IgG integrity relative to traditional IGIM products. Moreover, acceptable results were obtained in all in vitro and in vivo pre-clinical toxicology testing, as well as clinical evaluation. Scaled-down experiments demonstrated that the new process provides effective viral inactivation. Taken together, these results indicate that the new products should have the same efficacy of the previous IGIM products albeit with safety and processing improvements.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Antivirales
/
Organofosfatos
/
Inmunoglobulinas
/
Contaminación de Medicamentos
/
VIH-1
/
Colato de Sodio
Límite:
Humans
Idioma:
En
Revista:
Biologicals
Asunto de la revista:
ALERGIA E IMUNOLOGIA
Año:
2000
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Reino Unido