ABSTRACT
A monografia farmacopeica da vacina tríplice viral (sarampo/caxumba/rubéola) exige a validação de desempenho do ensaio de potência utilizando-se apropriado material de referência (MR). Com o intuito de estabelecer o primeiro MR de trabalho (MRT) nacional para a vacina tríplice viral, foi realizado o estudo colaborativo nacional com a participação de duas únicas instituições que executam o ensaio de potência desta vacina, o Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos, produtor nacional) e o Instituto Nacional de Controle de Qualidade em Saúde.O material candidato (cMRTBio), preparado pelo produtor, foi avaliado pelos laboratórios participantes utilizando-se as respectivas metodologias in-house de determinação de potência. O cMRTBio foi considerado apropriado como MR in-house por estar em concordância com as especificações recomendadas nas normativas de compêndios, a saber: variações intra- (< 5 %), inter-ensaios (< 10 %) e entre laboratórios (< 10 %) abaixo dos limites aceitáveis; e potência estimada (log10 CCID50/DH) em 3,72 para sarampo, 4,80 para caxumba e 3,70 para rubéola. Este trabalho reflete o compromisso do único produtor nacional da vacina tríplice viral com a saúde pública, descrevendo-se a expansão da tecnologia, o cumprimento às diretrizes internacionais, o cuidado com o controle da qualidade e culminância para a autossuficiência nacional na produção de vacinas.
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 firstwork 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.
Subject(s)
Quality Control , Pharmacopoeias as Topic , Measles-Mumps-Rubella Vaccine , VaccinesABSTRACT
Leprosy is an infectious disease caused by Mycobacterium leprae that affects the skin and nerves, presenting a singular clinical picture. Across the leprosy spectrum, lepromatous leprosy (LL) exhibits a classical hallmark: the presence of a collection of M. leprae-infected foamy macrophages/Schwann cells characterised by their high lipid content. The significance of this foamy aspect in mycobacterial infections has garnered renewed attention in leprosy due to the recent observation that the foamy aspect represents cells enriched in lipid droplets (LD) (also known as lipid bodies). Here, we discuss the contemporary view of LD as highly regulated organelles with key functions in M. leprae persistence in the LL end of the spectrum. The modern methods of studying this ancient disease have contributed to recent findings that describe M. leprae-triggered LD biogenesis and recruitment as effective mycobacterial intracellular strategies for acquiring lipids, sheltering and/or dampening the immune response and favouring bacterial survival, likely representing a fundamental aspect of M. leprae pathogenesis. The multifaceted functions attributed to the LD in leprosy may contribute to the development of new strategies for adjunctive anti-leprosy therapies.
Subject(s)
Humans , Leprosy, Lepromatous/pathology , Mycobacterium leprae/immunology , Schwann Cells/microbiology , Inclusion Bodies/immunology , Inclusion Bodies/metabolism , Inclusion Bodies/pathology , Leprosy, Lepromatous/immunology , Lipids/immunology , Organelles/immunology , Schwann Cells/immunologyABSTRACT
Thirty-eight Azotobacter spp strains isolated from Brasilian soils were characterized for the foollowing properties : utilization of different carbon sources, diffusible pigment production, melanin production, sodium-dependent growth, siderophore production, streptomycin resistance and antibiotic-like substances production. Four strains were identified : one as A. armeniacus and three as A. paspali.