Related Experiment Videos
Studies on yellow fever vaccine. I. Quality-control parameters
O de Souza Lopes1, S S de Almeida Guimaràes, R de Carvalho
1Fundação Oswaldo Cruz, BIO-Manguinhos, Rio de Janeiro, RJ, Brasil.
Journal of Biological Standardization
|October 1, 1987
Summary
Quality control for yellow fever vaccine production involves monitoring virus titre throughout manufacturing. Freezing and thawing cycles can impact virus stability, necessitating careful handling during production.
Area of Science:
- Virology
- Vaccinology
- Biotechnology
Background:
- Yellow fever vaccine production requires stringent quality control measures.
- Established parameters are crucial for ensuring vaccine efficacy and safety.
- Fundação Oswaldo Cruz in Brazil produces yellow fever vaccine using embryonated eggs.
Purpose of the Study:
- To establish and apply several parameters for the quality control of yellow fever vaccine.
- To assess the impact of specific production steps on virus titre and stability.
Main Methods:
- Vero cell plaque titration technique was employed for virus quantification.
- A local reference vaccine with a known infectivity titre was used as a standard.
- Virus titres were measured at various stages, including embryo pulp, embryo juice, and final product.
Main Results:
- One freeze-thaw cycle did not significantly affect virus titre.
- A second thawing cycle led to a reduction in virus titre.
- Virus losses during lyophilization and thermodegradation were quantified.
Conclusions:
- Established parameters are being applied to all production steps for strict quality control.
- Monitoring virus titre and stability is essential throughout the yellow fever vaccine manufacturing process.
- Understanding the impact of procedures like freezing and thawing is critical for maintaining vaccine potency.