Abstract

PARDO, Georgina et al. In vivo determination of adventitious agents in BHK-21 cells used in the production of biologicals. Vaccimonitor [online]. 2000, vol.9, n.2, pp. 23-28. ISSN 1025-0298.

Acceptance of cell lines as a substrate for production of pharmaceuticals has been a controversial topic since 1987. The cells are generally tested according to the recommendations that appear in “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals”. They should be free from adventitious agents; among others in vitro and in vivo tests are recommended for this purpose. In this report BHK-21-cell clone 13 from new born Syrian hamster kidney cells is assayed in vivo to determine adventitious agents; it is also tested for nonspecific innocuousness in experimental animals. In vivo tests included the inoculation of adult mice,suckling mice, guinea pigs, rabbits, and embryonated chicken eggs by the yolk sac and allantoic routes of inoculation. All animals were observed for clinical signs of viral infection. Egg viability was determined. The results showed that 100% of the animals and eggs remained healthy and survived the observation period. The cell bank was free of haemadsorbent, haemagglutinating, lymphocytic chroriomeningitis and Coxsakie viruses. The weights of the tested animals were higher than the weights of the control animals. The cells did not present evidences of adventitious agents in the in vivo assays and they were well accepted by the experimental animals.

Keywords : Characterization; BHK-21 cells; adventitious agents; experimental animals.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )