Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos最新文献

{"title":"Evaluation of the in vitro biological activity of biosimilar and biobetter versions of rituximab developed in Bio-Manguinhos for lymphoma treatment","authors":"A. Frederico, M. D. G. M. Teixeira, E. Santos, L. Barros, M. Duarte, M. Bonamino, Aline A. Oliveira","doi":"10.35259/ISI.SACT.2019_32657","DOIUrl":"https://doi.org/10.35259/ISI.SACT.2019_32657","url":null,"abstract":"Introduction: Monoclonal antibodies (mAbs) have revolutionized cancer treatment since the approval of Rituximab for non-Hodgkin’s lymphoma (NHL). New anti-CD20 antibodies have been developed, including biosimilars and biobetters. Biosimilars are mAbs that have the same amino acid sequence as the reference mAb (commercial therapeutic product) but are produced by other manufacturing processes. Biobetters have the same target epitope as the reference mAb, however they do have some structural modifications to make it better than the reference mAb. Since many patients do not respond to treatment with anti-CD20 antibodies, biobetters appear as a valid alternative for the treatment of NHL. The main mode of action of these anti CD20 mAbs is through Antibody-Dependent Cellular Citotoxicity (ADCC), involving the activation of Natural Killers (NK) cells. These cells can act through the interaction of receptors such as NKG2D with its ligands (NKG2DL) found on the surface of target cells. Our group proposes the development of a biosimilar of rituximab and the creation of a biobetter antibodies based on the addition of an NKG2D ligand to the mAb structure.","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121214298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) for Rapid Detection of ZIKV in Human Samples","authors":"Severino Jefferson Ribeiro da Silva, L. Pena","doi":"10.35259/isi.sact.2019_32816","DOIUrl":"https://doi.org/10.35259/isi.sact.2019_32816","url":null,"abstract":"","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"266 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116451626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Initial assays for the characterization of a biosimilar anti-PD-1 monoclonal antibody to Nivolumab","authors":"M. Ramos, A. Bom, R. Bastos, A. Araújo, Aline A. Oliveira, P. C. Neves, Haroldo Cid da Silva Junior","doi":"10.35259/ISI.SACT.2019_32651","DOIUrl":"https://doi.org/10.35259/ISI.SACT.2019_32651","url":null,"abstract":"Introduction: According to the World Health Organization (WHO), cancer is the second leading cause of death in world’s population. In Brazil, it’s expected the occurrence of 600.000 new cases for year for the biennium 2018-2019. The immune system acts controlling and eradicating the disease. However, in malignancy scenario, several mechanisms of immune suppression may be present, reducing the antitumor immunity of the host. Thus, antibody therapy against immunological checkpoints, such as programmed cell death 1 (PD-1), has been shown to be successful in reversing immunosuppression. Biosimilars are biological medicines that have the same safety and efficacy as reference medicines. The substitution of reference products for biosimilars may increase patients’ access to these drugs as well as reduce public health expenditures.","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"594 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121981160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardization of an in vitro assay for the evaluation of a candidate yellow fever vaccine","authors":"Andréa M V Silva, Tamiris Azamor, L. R. Batista-Silva, N. Benigno, Thyago Leal Calvo, Camilla Bayma, D. Matos, M. Moraes","doi":"10.35259/isi.sact.2019_32551","DOIUrl":"https://doi.org/10.35259/isi.sact.2019_32551","url":null,"abstract":"","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"35 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128293701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving the autocleavage performance of human L-asparaginase: a novel solution to overcome the challenges of leukemia treatment","authors":"S. B. Morais, T. Souza","doi":"10.35259/isi.sact.2019_32692","DOIUrl":"https://doi.org/10.35259/isi.sact.2019_32692","url":null,"abstract":"","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128712068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Assessment based approach to support the qualification of equipment: a case study application on a mammalian cell bioreaction system","authors":"Miguel O Herrera, Rodrigo Coelho Ventura Pinto, E. Lemes, Danilo Parmera","doi":"10.35259/ISI.SACT.2019_32652","DOIUrl":"https://doi.org/10.35259/ISI.SACT.2019_32652","url":null,"abstract":"Introduction: The equipment qualification within the pharmaceutical industry, besides being mandatory, is indispensable to verify that any equipment was designed, installed, and operates to perform the expected function. However, high technological complexity of innovative and customized systems makes it difficult to execute this task, requiring high human and financial resources. To face this situation, a risk analysis based approach has been used to simplify the qualification tests in key elements and critical functions within the system, resulting in the optimization of resources and reduction of qualification time, which in some cases may take years.","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128926640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reduction of the cycle of lyophilization of the vaccine atenuated Yellow Fever presentation 02 and 05 doses of Bio-Manguinhos","authors":"Patricia Alvarenga Agra, S. Assumpção, C. Crespo, V. Calado","doi":"10.35259/isi.sact.2019_32597","DOIUrl":"https://doi.org/10.35259/isi.sact.2019_32597","url":null,"abstract":"Introduction: With the outbreak of Yellow Fever in mid-2017, WHO recommended vaccination in risk areas and other regions of Brazil, made it necessary to increase the vaccine offer at the national level (PNI) and also international, backed by law 13801 -2019 sanctioned by the federal government in January 2019 which increases the Institutional commitment with the supply of vaccines for PAHO and UNICEF (www.fiocruzbrasilia.fiocruz.br). Bio-Manguinhos, maintaining an institutional commitment to the supply of vaccines, has articulated to increase its productive capacity without generating additional financial costs as well as to increase the supply of this vaccine through the optimization of its freeze-drying cycle.","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123911466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Linear B-cell epitopes on Zika virus´s envelope protein: a rational approach to determination of highly specific targets against Zika virus","authors":"Rodrigo Silva, F. Conte, S. Fontes, P. C. Neves, J. C. Sánchez-Arcila, L. Pinto","doi":"10.35259/ISI.SACT.2019_32655","DOIUrl":"https://doi.org/10.35259/ISI.SACT.2019_32655","url":null,"abstract":"Introduction: Zika virus (ZIKV) is an arbovirus and belongs to the Flaviviridae family, like the related dengue, yellow fever, West Nile, and Japanese encephalitis viruses. Although ZIKV usually causes an asymptomatic or mildly symptomatic disease in infected adults, it can lead to severe brain abnormalities in fetuses, who are infected in utero by vertical transmission of the virus through the placenta, and is associated with serious neurological complications such Guillain-Barre syndrome and meningoencephalitis. Despite this, there are no specific treatments or vaccines against ZIKV. On this context, considering that the Envelope protein of Flavivirus is essential to invasion of host cells and is the major target of neutralizing antibodies, the identification of its immunogenic regions is a crucial step to the development of immunotherapies based on monoclonal antibodies and novel vaccines.","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123991367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The review process of Bio-Manguinhos' strategic plan and its immediate impacts","authors":"Rosangela Silva, E. Gomes, Lethícia Vivas, M. Barbosa, P. Barbosa","doi":"10.35259/isi.sact.2019_32782","DOIUrl":"https://doi.org/10.35259/isi.sact.2019_32782","url":null,"abstract":"Introduction: The Immunobiological Technology Institute (Bio-Manguinhos) has recently finalized its Strategic Plan for the next 10 years. The challenge of conducting it to a sustainable future is based on search for excellence in management, investment in the development of products, services and innovative processes, modernization of physical facilities, socioenvironmental responsibility, strengthening of technological platforms and essential skills to the consolidation of its strategic role for Public Health. At the current Brazilian political juncture, short-term scenarios require immediate actions, demanding an option of fast organizational mobilization, by differentiated actions for the short-term – 2019-2020 – while taking into account the medium and long-term scenarios.","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"85 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121153959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Macromolecule Laboratory (LAMAM): evaluation of 10 years of experience to face a new challenge","authors":"H. Nascimento, R. Bastos, P. Jurgilas, A. Bom, L. Vidal, Izabella Sodré Buty da Silva, P. Guzzo, R. Guerra, J. D. S. G. Junior","doi":"10.35259/ISI.SACT.2019_32774","DOIUrl":"https://doi.org/10.35259/ISI.SACT.2019_32774","url":null,"abstract":"Introduction: The scarcity of financial resources on the national scene and the high costs of maintaining research laboratories have prompted the search for new sources of funding and partnerships for research and development institutions. Therefore, a way in which research laboratories operate as internal and external service providers has been discussed in BioManguinhos. LAMAM as a laboratory specialized in the field of macromolecules matches the concept of outsourcing of service as many biotechnology companies abroad. For this purpose, it is necessary to apply a laboratory management model for quick decision-making and for the choice of technological platforms to be made available to potential partners. Objective: Apply a laboratory management model based on indicators to evaluate bottlenecks and select potential technological plataforms executed on LAMAM to provide internal demands and external services. Methodology: We selected the SMART method (Specific, Measurable, Achievable, Relevant, Time-Based) for laboratory management, which is a model based on the choice of key performance indicators, subdivided in different categories: Performance (number of demanded procedures, developed activities, introduction of processes control); Human Resources (academic formation and produtivity), External Sources (grants founding obtained, external partnerships) and Regulatory Compliance. As for database were used the records of the last five to ten years of LAMAM. Results: Regarding to the performance indicators the most requested platform is the chromatographic followed by physico-chemical characterizations, corresponding to 55.4% and 23.0% of the executed demands over the last 5 years. The number of collaborations in projects of Bio-Manguinhos portfolio is around 11, however the level of requisition for activities performed increased considerably with the introduction of internal process controls since 2015. Over the last ten years LAMAM has continuously invested in the training of its professionals, which reflected directly the increase, since 2009, of published manuscripts (2.3/ year), pos-graduated students (1.8/year), external collaborations (11 collaborations/year, since 2017), contemplated projects (6 since 2014) and effective participations in three collaborative FIOCRUZ networks (Nano, Cancer and Chagas). LAMAM has all its employees properly trained in Good Laboratories Practices and Biosafety and since 2015, the laboratory began to produce operating instructions and standard operating procedures. The forecast for 2019 is an implementation of a sistematic study for valuation and cost of activities. Conclusion: Over the last 10 years, LAMAM has effectively acted in the training of human resources. The increase of internal and external demands has evidenced the applicability of LAMAM as a facility in the area of macromolecules. According to the inventory, technological platforms to be iniatially offered for external services could be chromatograph","PeriodicalId":427855,"journal":{"name":"Anais do IV International Symposium on Immunobiological e VII Seminário Anual Científico e Tecnológico de Bio-Manguinhos","volume":"239 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130182113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}