National collaborative study for establishing the working reference material of the vaccine against measles/mumps and rubella: evolution to the self-sufficiency in the national production of triple viral vaccine
Vol. 74 No. 3 (2015), ORIGINAL ARTICLE
Vol. 74 No. 3 (2015)

National collaborative study for establishing the working reference material of the vaccine against measles/mumps and rubella: evolution to the self-sufficiency in the national production of triple viral vaccine

ORIGINAL ARTICLE
https://doi.org/10.53393/rial.2015.v74.33471
Published 2016-05-05
Danielle da Silva Almeida
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
Paulo César Dick
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
Carlos José da Silva
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
Ingrid Pinheiro de Medeiros
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
Carina Cantelli Pacheco de Oliveira
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
Darcy Akemi Hokama
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
Jarbas Emilio dos Santos
Fundação Oswaldo Cruz, Instituto Nacional de Controle da Qualidade em Saúde, Laboratório de Vacinas Virais e Cultura de Células, Manguinhos, RJ
Patricia dos Santos Alves
Fundação Oswaldo Cruz, Instituto Nacional de Controle da Qualidade em Saúde, Laboratório de Vacinas Virais e Cultura de Células, Manguinhos, RJ
Lucia Maria Correa Werneck
Fundação Oswaldo Cruz, Instituto Nacional de Controle da Qualidade em Saúde, Laboratório de Vacinas Virais e Cultura de Células, Manguinhos, RJ
Lilia Ribeiro Seródio
Fundação Oswaldo Cruz, Instituto Nacional de Controle da Qualidade em Saúde, Núcleo Técnico de Produtos Biológicos, Manguinhos, RJ
Karen Friedrich
Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Toxicologia e Farmacologia, Manguinhos, RJ
Katherine Antunes de Mattos
Fundação Oswaldo Cruz, Instituto de Tecnologia em Imunobiológicos, Departamento da Qualidade, Laboratório de Controle de Qualidade, Manguinhos, RJ
PDF (Português (Brasil))

Keywords

reference material
biological potency
MMR vaccine

How to Cite

1.
Almeida D da S, Dick PC, Silva CJ da, Medeiros IP de, Oliveira CCP de, Hokama DA, Santos JE dos, Alves P dos S, Werneck LMC, Seródio LR, Friedrich K, Mattos KA de. National collaborative study for establishing the working reference material of the vaccine against measles/mumps and rubella: evolution to the self-sufficiency in the national production of triple viral vaccine. Rev Inst Adolfo Lutz [Internet]. 2016 May 5 [cited 2024 Jul. 22];74(3):178-89. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/33471
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Abstract

The pharmacopoeia monograph for the measles/mumps and rubella (MMR) triple vaccine demands to perform the validation of the potency assay by using the suitable reference material (MR). Aiming at establishing the first work MR (MRT) for the MMR triple vaccine, a national collaborative study was performed with the participation of the two unique national institutions working on the vaccine potency evaluation test, the Imunobiological Technology Institute (Bio-Manguinhos, national manufacturer) and the National Institute for Quality Control in Health. The candidate product (cMRTBio) prepared by the manufacturer was evaluated by the participant laboratories by employing the respective in-house methodologies for determining the potency. The cMRTBio was considered suitable as in-house MR, according to the specifications based on the normative compendia, being the intra-assay (< 5 %), inter-assay
(< 10 %) and between laboratories variations (< 10 %) below the acceptable limits, and the estimate potency (log10 CCID50/DH) in 3.72 for measles, 4.80 for mumps and 3.70 for rubella. This study reflects the commitment of the unique national MMR vaccine producer to the public health, describing the expansion of technology, the compliance with international guidelines and the careful quality control, leading to the national self-sufficiency in the vaccine production.

https://doi.org/10.53393/rial.2015.v74.33471
PDF (Português (Brasil))

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