Angel de la O Herrera M.,Institute Tecnologia em Imunobiologicos Bio Manguinhos FIOCRUZ |
Angel de la O Herrera M.,State University of Rio de Janeiro |
Luna A.S.,State University of Rio de Janeiro |
da Costa A.C.A.,State University of Rio de Janeiro |
Blanco Lemes E.M.,Institute Tecnologia em Imunobiologicos Bio Manguinhos FIOCRUZ
Journal of Loss Prevention in the Process Industries | Year: 2015
Recently, the use of analytical techniques to identify, assess and address risks within the pharmaceutical industry is increasing from the initial and operating phases until the final use of products aiming to eliminate or reduce the severity of deviations. The hazard and operability studies - HAZOP establish that accidents are the result of failure modes in process variables out of operational parameters. In this paper, the HAZOP methodology was used to assess risks in the system for recombinant protein production where a multidisciplinary group used the brainstorming strategy to identify the risk level and deviations in nodes defined by functionality in the system. Nineteen critical nodes were identified, deviations were established in based on knowledge, and experience by the group, thus precluded the need of deviation's records to estimate frequency and impacts of events. It was also shown that in the pharmaceutical industry the most-critical risks are those that have adverse impacts on production like partial and total losses and when noncompliance of regulations are involved. The HAZOP risk assessment tool can be easily followed by people who are interested in starting to use this technique to improve the security environment within the institution and when required by regulatory agencies. © 2015 Elsevier Ltd.
Farias R.H.,Institute Tecnologia em Imunobiologicos Bio Manguinhos FIOCRUZ |
Noronha T.G.,Institute Tecnologia em Imunobiologicos Bio Manguinhos FIOCRUZ |
Lemos J.A.,Secretaria de Estado de Saude |
von Doellinger V.R.,Institute Tecnologia em Imunobiologicos Bio Manguinhos FIOCRUZ |
And 20 more authors.
Human Vaccines and Immunotherapeutics | Year: 2016
A single vaccination of Yellow Fever vaccines is believed to confer life-long protection. In this study, results of vaccinees who received a single dose of 17DD-YF immunization followed over 10 y challenge this premise. YF-neutralizing antibodies, subsets of memory T and B cells as well as cytokine-producing lymphocytes were evaluated in groups of adults before (NVday0) and after (PVday30-45, PVyear1-4, PVyear5-9, PVyear10-11, PVyear12-13) 17DD-YF primary vaccination. YF-neutralizing antibodies decrease significantly from PVyear1-4 to PVyear12-13 as compared to PVday30-45, and the seropositivity rates (PRNT≥2.9Log10mIU/mL) become critical (lower than 90%) beyond PVyear5-9. YF-specific memory phenotypes (effector T-cells and classical B-cells) significantly increase at PVday30-45 as compared to naïve baseline. Moreover, these phenotypes tend to decrease at PVyear10-11 as compared to PVday30-45. Decreasing levels of TNF-α+ and IFN-γ+ produced by CD4+ and CD8+ T-cells along with increasing levels of IL-10+CD4+T-cells were characteristic of anti-YF response over time. Systems biology profiling represented by hierarchic networks revealed that while the naïve baseline is characterized by independent micro-nets, primary vaccinees displayed an imbricate network with essential role of central and effector CD8+ memory T-cell responses. Any putative limitations of this cross-sectional study will certainly be answered by the ongoing longitudinal population-based investigation. Overall, our data support the current Brazilian national immunization policy guidelines that recommend one booster dose 10 y after primary 17DD-YF vaccination. © 2016, © Ana Carolina Campi-Azevedo, Christiane Costa-Pereira, Lis R Antonelli, Cristina T Fonseca, Andréa Teixeira-Carvalho, Gabriela Villela-Rezende, Raiany A Santos, Maurício A Batista, Fernanda M Campos.