On-line version ISSN 1025-0298
PARDO, Georgina et al. In vitro assay to determine the presence of adventitious agents in a Working Cell Bank. Vaccimonitor [online]. 2001, vol.10, n.1, pp. 17-21. ISSN 1025-0298.
At present tissue culture collections are considered valuable sources of biological material for research and production, nevertheless they are really useful when they are well organized, characterized and handled as Master Cell Banks and Working Cell Banks, depending on the objectives of the work. Regulatory agencies all over the world consider that the establishment of Master Cell Banks and Working Cell Banks follows good manufacturing practices in effect and the “Points to consider in the Characterization of Cell Lines used for the Production of Biologicals”. The objective of this work was to determine if a Working Cell Bank (WCB) obtained in our laboratory was free of adventitious agents. To achieve this, optical and electronic microscopy were carried out looking for the morphology or presence of retrovirus. Absence of bacterial, fungi and micoplasma contamination was also verified. Also the presence of other adventitious agents tested using three cell culture systems. The cell morphology was pseudo fibroblastic as reported for this cell line. The Cell Bank is free of bacteria, fungi and micoplasma. The results of the test for adventitious agents were negative, electronic microscopy observation didn’t reveal type A or C retroviral particles. As a conclusion we may say that the Working Cell Bank complies with the regulations established and can be used in the production of veterinary vaccines.
Keywords : Working Cell Bank; BHK- 21; Characterization.