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Este artículo proporciona un caso de estudio del uso del Análisis Modal de Fallos y Efectos para identificar y evaluar los riesgos de un posible cambio del lote de siembra de trabajo en el Instituto Finlay de Vacunas. Este análisis tuvo lugar en uno de los procesos críticos de las Plantas de Producción de Ingrediente Farmacéutico Activo del Instituto Finlay de Vacunas. No incluyó cambios en la tecnología de obtención del Lote de Siembra de Trabajo, ni cambios en el Lote de Siembra de Referencia. Como resultado, se identificaron ocho riesgos potenciales y de ellos se valoraron 17 causas, las cuales se asocian principalmente a la contaminación del Lote de Siembra de Trabajo o baja viabilidad del Lote de Siembra de Referencia, uso de materias primas y materiales de proveedores no calificados o posteriores al período de vigencia, errores de manipulación, parámetros de operación inadecuados, uso de medios de cultivo, soluciones y materiales contaminados, inadecuado funcionamiento del equipamiento e instalaciones y personal no capacitado. Los riesgos identificados son aceptables, con una probabilidad baja de ocurrencia y no están vinculados a la seguridad y eficacia del Ingrediente Farmacéutico Activo, ni de las vacunas. Por último, se propuso una estrategia que minimiza los posibles fallos ante un cambio de Lote de Siembra de trabajo para la fabricación de un producto biofarmacéutico(AU)
This article provides a case study of the use of Modal Failure and Effects Analysis to identify and assess the risks of a possible change in the Working Seed Lot at Finlay Vaccine Institute. This analysis took place in one of the critical processes of the Active Pharmaceutical Ingredient Production Plants of the Finlay Vaccine Institute. This analysis did not include changes in the technology for obtaining the Working Seed Lot or changes in the Reference Seed Lot. As a result, eight potential risks were identified and 17 causes were assessed, mainly associated with contamination of the Working Seed Lot or low viability of the Reference Seed Lot, use of raw materials and other materials from unqualified suppliers or after the validity period, handling errors, inadequate operating parameters, use of culture media, contaminated solutions and materials, inadequate operation of equipment and facilities, and untrained personnel. The identified risks are acceptable, with a low probability of occurrence and are not linked to the safety and efficacy of the active pharmaceutical ingredient or vaccines. Finally, a strategy was proposed that minimizes possible failures in the event of a change in Working Seed Lot for the manufacture of a biopharmaceutical product(AU)
Subject(s)
Humans , Male , Female , Risk Management , Biological Phenomena , VaccinesABSTRACT
Abstract Introduction Hematopoietic Stem Cell Transplant (HSCT) has been successfully used as standard therapy for hematological disorders. After conditioning therapy, patients undergoing allogeneic HSCT, present three different phases of engraftment: early pre-engraftment, early post-engraftment, and late engraftment. Severe complications are associated with morbidity, mortality, and malignancies in these phases, which include effects on the oral cavity. Objectives The changes in the salivary composition after HSCT may contribute to identifying relevant proteins that could map differences among the phases of diseases, driven for personalized diagnostics and therapy. Methods Unstimulated whole saliva was collected from patients submitted to HSCT. The samples were submitted to trypsin digestion for a Mass spectrometry analysis. MaxQuant processed the Data analysis, and the relevant expressed proteins were subjected to pathway and network analyses. Results Differences were observed in the most identified proteins, specifically in proteins involved with the regulation of body fluid levels and the mucosal immune response. The heatmap showed a list of proteins exclusively expressed during the different phases of HSCT: HBB, KNG1, HSPA, FGB, APOA1, PFN1, PRTN3, TMSB4X, YWHAZ, CAP1, ACTN1, CLU and ALDOA. Bioinformatics analysis implicated pathways involved in protein processing in the endoplasmic reticulum, complement and coagulation cascades, apoptosis signaling, and cholesterol metabolism. Conclusion The compositional changes in saliva reflected the three phases of HSCT and demonstrated the usefulness of proteomics and computational approaches as a revolutionary field in diagnostic methods.
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P73 protein is one of the main members of p53 protein family, and its coding gene TP73 is highly homologous to TP53 gene. On one hand, similar to p53, p73 protein is involved in all aspects of cell life. On the other hand, unlike the p53, not only p73 protein plays the role of tumor suppressor in normal cell activities and tumor development, but also the function of p73 protein is no less complex and important than that of p53 protein. Tumorigenesis involves a variety of cellular biological processes, such as apoptosis, autophagy, cell migration and cell metabolism. These normal cellular biological processes are tightly regulated by multiple cellular signaling pathways to maintain homeostasis. Once a carcinogenic abnormality occurs, it will eventually lead to tumorigenesis. Therefore, this paper mainly focuses on the important research results of p73 and tumorigenesis and its unique function different from p53 protein in recent years.
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ABSTRACT COVID-19 (coronavirus disease 2019) is an infectious disease caused by the new coronavirus associated with severe acute respiratory syndrome 2 (SARS-CoV-2). Coronaviridae comprises a large family, of which at least seven members are known to cause respiratory diseases in humans. Coronaviruses have the ability to infect virtually all major groups of animals and, eventually, can infect humans. SARS-CoV-2 is the third coronavirus to cross the species barrier and infect humans. This virus was identified in an outbreak of pneumonia cases in Wuhan city, Hubei province, China, in December 2019. Its entire genome is inscribed on a single strand of ribonucleic acid. Some proteins present on the surface of the virus act as facilitators for its entry into host cells, while others, apparently, are related to its pathogenesis. Coronaviruses are responsible for respiratory infections in humans and some animals. The infection is often mild to moderate in intensity, but some coronaviruses may cause serious illnesses, such as severe acute respiratory syndrome (SARS), which occurred in 2002, and the Middle East respiratory syndrome (MERS). Coronaviruses can activate an excessive and unregulated immune response, which may promote SARS development. Although the lungs are one of the target organs, the hypoxia mechanism is systemic and other organs begin to suffer both through lack of oxygen and through deregulation of inflammation control mechanisms.
Subject(s)
Humans , Animals , Pneumonia, Viral/diagnosis , Coronavirus Infections/diagnosis , Clinical Laboratory Techniques , Pandemics , China , Betacoronavirus , COVID-19 Testing , SARS-CoV-2 , COVID-19ABSTRACT
RESUMO Misturas diferentes de lixiviado de aterro sanitário e esgoto doméstico foram aplicadas em 16 reatores em batelada usando o processo PACT® (lodos ativados com adição de carvão ativado em pó - CAP). O objetivo do trabalho foi representar a remoção de cor utilizando dois ajustes matemáticos: o primeiro combinou as variáveis concentração de CAP (0 a 6 g.L-1) e mistura lixiviado/esgoto (0 a 10%, em volume); e o segundo, a concentração de CAP e a cor da mistura (276 a 1.199 uH). A metodologia de superfície de resposta (MSR) foi escolhida para representar a resposta dos ajustes. Os resultados indicaram que, conforme a concentração de lixiviado aumentou até 5%, a adição de CAP resultou em um maior percentual de remoção de cor. No entanto, para a mistura com 10% de lixiviado, os reatores perderam eficácia, com exceção do reator com 6 g.L-1 de CAP, que apresentou os melhores resultados de remoção de cor.
ABSTRACT Sixteen batch reactors fed with different mixtures of landfill leachate combined with synthetic wastewater were treated using the PACT® process (activated sludge process plus powdered activated carbon addition - PAC). The objective was to measure the color removal using two mathematical adjustments: the first adjustment combined the variables PAC concentration (0 to 6 g.L-1) and landfill leachate concentration in the wastewater (0 to 10%, in volume); and the second model combined PAC concentration and the influent color (276 to 1,199 uH). The response surface methodology was used to describe the response of both adjustments. The results indicated that as the proportion of leachate was increased up to 5%, higher PAC concentrations resulted in a better color removal in the reactors. When the leachate proportion was 10%, the reactors were less efficacious, except for the one with 6 g.L-1, which presented the highest color removal within the experiment.
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La consolidación es un proceso biológico único y muy bien organizado, que culmina con la restauración y completa función mecánica del hueso. Pero existen factores, como la osteoporosis y el envejecimiento, que pueden alterar su secuencia y prolongarla en el tiempo. Esta revisión bibliográfica busca poner al día lo que se conoce sobre la consolidación en el anciano.
The consolidation process is a unique biological and very well organized, culminating in the complete restoration and mechanical operation of the bone. But there are factors such as osteoporosis and aging, which may alter the sequence and continue. This literature review seeks to update what is known about the consolidation in the elderly.