| Author | Agra, Patricia Alvarenga | |
| Author | Costa, Jorge Carlos Santos da | |
| Author | Crespo, Celso Faria | |
| Author | Assumpção, Sérgio Luiz de Lima | |
| Author | Vicosa, Alessandra Lifsitch | |
| Access date | 2024-05-06T19:41:13Z | |
| Available date | 2024-05-06T19:41:13Z | |
| Document date | 2024 | |
| Citation | AGRA, Patricia Alvarenga et al. Influence of Collapse Temperature on Freeze Drying of an Immunobiological Product: Cryomicroscopy - Overview of the Technique, Results and Applications. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 8., 2024. Rio de Janeiro. Annals... Rio de Janeiro: Bio-Manguinhos, 2024. p. 43. | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/63923 | |
| Language | eng | en_US |
| Publisher | Instituto de Tecnologia em Imunobiológicos (Bio-manguinhos) | en_US |
| Rights | open access | en_US |
| Subject in Portuguese | Liofilização | en_US |
| Subject in Portuguese | Febre Amarela | en_US |
| Subject in Portuguese | FDM | en_US |
| Title | Influence of Collapse Temperature on Freeze Drying of an Immunobiological Product: Cryomicroscopy - Overview of the Technique, Results and Applications | en_US |
| Type | Papers presented at events | |
| DOI | 10.35259/isi.biomang.2024_63923 | |
| Abstract | Introduction: Yellow fever is an infectious disease transmitted by arthropod vectors, associated with epidemic outbreaks, notable for its severity and impact on public health. In 2016, a recommendation made by the WHO, aligned with FIOCRUZ’s strategic plan, suggested improvements in processes, aiming to meet global demands in order to eliminate epidemic outbreaks (EYE Strategy-2017- 2026). In this context, freeze-drying is the crucial step in the vaccine production process, being critical, with a moderate impact according to RDC073/2016, bringing relevance to the study. Objectives: This study aims to study critical product parameters, in the freeze-drying of an optimized 2-dose yellow fever vaccine, using the freeze-drying microscopy technique -FDM. Specific Objective: To study the influence of the collapse temperature on the stability and quality of the product, to guarantee the safety and effectiveness of the vaccine in terms of product quality. Methodology: The research made use of experimental batches with an Exploratory method and a technological nature, and aimed to guarantee the quality and safety of the new product in comparison with the quality targets of the commercial batch with the use of FDM, a technique for characterizing and establishing critical parameters temperature of the vaccine. The data was analyzed statistically, and determining the critical limits of the product, with a redesign of the freeze-drying cycle bringing better quality to the product and greater stability. Results: Preliminary results of the experimental batches in comparison with the commercial batch indicated low variability between samples of the optimized 2-dose yellow fever vaccine. The results on the vaccine, after freeze-drying (redesign) using established product temperature limits, were consistent with commercial vaccine quality parameters ((potency 2° to 8° C: 5.1399 PFU/ml(α=0, 07); potency 37° C: 4.6305 PFU/ml(α=0.10); compliant appearance; homogeneity ok; RH% 0.94(α=0.04)), 95% confidence interval showing significance Conclusion: This study presents an innovative approach, with technological prospecting to optimize the freeze drying of vaccines, with the potential to improve product quality on a global scale and strengthen public health. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Presidência. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos (Farmanguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos (Farmanguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
| Subject | Attenuated Yellow Fever | en_US |
| Subject | FDM | en_US |
| Subject | Freeze drying | en_US |
| DeCS | Liofilização | en_US |
| DeCS | Febre Amarela | en_US |
