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https://www.arca.fiocruz.br/handle/icict/63923
INFLUENCE OF COLLAPSE TEMPERATURE ON FREEZE DRYING OF AN IMMUNOBIOLOGICAL PRODUCT: CRYOMICROSCOPY - OVERVIEW OF THE TECHNIQUE, RESULTS AND APPLICATIONS
Author
Affilliation
Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-manguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Presidência. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos (Farmanguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-manguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-manguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos (Farmanguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Presidência. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos (Farmanguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-manguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-manguinhos). Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos (Farmanguinhos). Rio de Janeiro, RJ, Brasil.
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.
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