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Advances and challenges in therapeutic monoclonal antibodies drug development BJPS
Santos,Mariana Lopes dos; Quintilio,Wagner; Manieri,Tania Maria; Tsuruta,Lilian Rumi; Moro,Ana Maria.
The use of serum containing polyclonal antibodies from animals immunized with toxins marked the beginning of the application of antibody-based therapy in late nineteenth century. Advances in basic research led to the development of the hybridoma technology in 1975. Eleven years later, the first therapeutic monoclonal antibody (mAb) was approved, and since then, driven by technological advances, the development of mAbs has played a prominent role in the pharmaceutical industry. In this review, we present the developments to circumvent problems of safety and efficacy arising from the murine origin of the first mAbs and generate structures more similar to human antibodies. As of October 2017, there are 61 mAbs and 11 Fc-fusion proteins in clinical use. An...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Immunotherapy; CDR grafting; Phage display; Transgenic mice; Single B cell sorting..
Ano: 2018 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000700406
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Comparative analysis of the intracerebral mouse protection test and serological method for potency assays of pertussis component in DTP vaccine BJM
Matos,Denise Cristina Souza; Marcovistz,Rugimar; Silva,Andréa Marques Vieira da; Quintilio,Wagner; Georgini,Ricardo Amaral.
The aim of this study was to compare the PSPT standardized in-house as an alternative to MPT for potency assays of pertussis component. Statistical analyses have showed similar pertussis potency values when PSPT was compared to MPT. Significant correlation between the potency results obtained by in vivo and in vitro assays was also been observed. Results by PSPT have demonstrated reproducibility and accuracy for potency pertussis control and this approach has been considered promising for use at least during the steps of production.
Tipo: Info:eu-repo/semantics/article Palavras-chave: DTP vaccine; Pertussis whole cell; Enzyme-linked immunosorbent assay; Intracerebral mouse protection test.
Ano: 2012 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822012000200001
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Monocyte Activation Test (MAT) as a possibility of replacement for the rabbit pyrogen test in hyperimmune sera BJPS
Utescher,Carla Lilian de Agostini; Buosi,Klariane Laís; Botosso,Viviane Fungaro; Quintilio,Wagner.
ABSTRACT The use of a commercial kit for the monocyte-activation test (MAT) was evaluated for assessing pyrogenic contamination of hyperimmune sera . Three batches of sera, two pyrogen free and one pyrogenic, were tested. Endotoxin spike recover indicated that sample dilutions from 1/2 to 1/10 are suitable. Kit transport and storage conditions were also evaluated, proving that an adequate cold chain must be assured to achieve good results. Furthermore, the commercial MAT kit seemed suitable to replace the rabbit pyrogen test (RPT) for pyrogen testing of hyperimmune sera, although further tests are needed to a full validation.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Monocytes Activation Test; Pyrogen; Hyperimmune serum; Pyrodetect kit; Cryoblood..
Ano: 2018 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200605
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