Anna C. R. Guimaraes, Simone F. T. Bastos, Patricia S. Alves; Jarbas E. dos Santos, Renata F. de Carvalho, Rafael L. Ferreira and e Marcelo L. L. Brandao
Department of Imunology, INCQS/Fiocruz, Brazil
Posters & Accepted Abstracts: J Vaccines Vaccin
Vaccines are considered the most powerful tools to prevent diseases. They are distinguished from chemical pharmaceuticals because they derive from living organisms. The Cell Bank of the National Institute of Quality Control in Health from Oswaldo Cruz Foundation (INCQS/Fiocruz) maintains a collection of cell lines applied in biological assays for quality control of products subjected to Sanitary Surveillance in Brazil. Following the World Health Organization (WHO) recommendation, the potency test is carried out of many biological assay and its authenticity and absence of contamination are critical factors. To minimize contamination the Organization for Economic Co-operation and Development (OECD) has published good practice for the use of cell lines and strongly recommends the use of cell derived from recognized collections. The aim of this work is to describe the Cell Bank performance in supply cells for potency assay for quality control of viral vaccines used in the Brazilian Immunization Program. The 8 different cell lines used in potency assay of viral vaccines were defrosted, amplified, and then trypsinized for the concentration adjustment for supply the laboratories that performed the potency assays. Sterility controls of the cell suspensions and culture medium were performed for all supplies. The data of potency assays of viral vaccines from the period 2007 to 2017 were collected from Harpya, the sample management system of INCQS/Fiocruz. During the evaluated period, 1,050 cell suspensions were supply to the laboratories that performed the analysis of 1,582 batches of viral vaccines, which were produced by 5 different manufacturers. Therefore, INCQS/Fiocruz namely his Cell Bank has a very important role in the Brazilian Immunization Program.
Anna C. R. Guimarães obtained her MSc in Sanitary Surveillance in 2014. She works at Immunology Division of INCQS/Fiocruz since 1995 and has extensive expertise at Cell Bank management, being part scientific papers and book chapters on cell culture procedures.