Detection of adventitious agents in rabies virus master seed

ALVAREZ IRENE; FRANCO LAUTARO; PEREZ LOPEZ JORGELINA; POLITZKI ROMINA; SCHAMMAS JUAN MANUEL; KARINA TRONO

buenos aires

Congreso; Rabies in the Americas; 2018

Panamerican Health Organization

Detection of adventitious agents in Rabies Virus Master Seed in Cell Cultures.Alvarez I 1,2, Franco L1, Perez Lopez J 1, Politzki R1, Schammas J 3, Trono K 1,2, 3.(1)Laboratorio de virus Adventicios, Instituto de Virología, INTA, Argentina, (2) CONICET, Argentina, (3) laboratorio de Bioseguridad Nivel 4 OIE, Instituto de Virología, INTA, ArgentinaManufacturers of biopharmaceutical products are required to produce a product that is safe for use in humans and animals. A major concern for many biological materials is viral contamination. Conventional adventitious virus testing in cell cultures have been applied as standard methods to exclude the presence of extraneous viruses in biological raw materials, cell culture substrates, viral seeds, and virus harvests used for biological medicinal products and vaccine manufacturing. The Adventitious laboratory in INTA have the facilities needed to perform the Adventitiuos agents control in biological products. The test schemes include in vitro tests in cell cultures or embryonated chicken eggs and in vivo tests in adult and suckling mice. In particularly, for Rabies Virus Master seed (MS), the sample is normally tested by inoculation into different cell cultures, including Vero cells, cells of the species for which the vaccine is recommended (human, canine, feline) and cells of the species for which the MS was isolated and/or propagated (bovine, porcine, rodent). As the Rabies Virus MS is capable of replicating in some cell in which it is to be tested, the MS must be neutralized prior to inoculating indicator cells. The cells are normally incubated at 37°C and observed for a period of 14-21 days, and is considered ?not-detected? if none of the cultures shows evidence for the presence of any extraneous agent, verified by microscopic evaluation throughout the observation period and at the end of the observation period by test for haemadsorbing viruses and for specific extraneous agents from bovine, porcine, feline and canine species by fluorescent immunodetection. MS and cell lines used to produce Rabies Virus vaccine must be tested using a broad range screening assay to detect any potential contamination caused by unspecified agents to ensure they are safe of adventitious agents.