Stability of lyophilized measles vaccine: Stabilizers and Temperature parameters | [Proceedings of the Pakistan Academy of Sciences: B. Life and Environmental Sciences • 2020]

Author(s):

1. Syeda Shazia Adeel: Department of Quality Assurance, National Institute of Health,Islamabad,Pakistan

2. Muhammad Babar Taj: Department of Chemistry, Islamia University of Bahawalpur, Pakistan;Department of Chemistry, University of Sahiwal, Sahiwal, Pakistan

3. Muhammad Sharif: Department of Chemistry, University of Sahiwal,Sahiwal,Pakistan

4. Asghar Ali: Quality Control Laboratory, National Institute of Health,Islamabad,Pakistan

5. Ayesha Khan: Department of Microbiology, Quaid-i -Azam University,Islamabad,Pakistan

6. Khalid Mehmood: Biological Production Division, National Institute of Health,Islamabad,Pakistan

7. Naeem Ghani: Quality Control Laboratory, National Institute of Health,Islamabad,Pakistan

8. Sajid Ali: Biological Production Division, National Institute of Health,Islamabad,Pakistan

9. Ghazala Parveen: Biological Production Division, National Institute of Health,Islamabad,Pakistan

Abstract:

The effectiveness of live measles vaccine is based on numerous factors like complete attenuation of the vaccine virus, appropriate stabilizer, pH, exposure to light, and also on the maintenance of cold chain (temperature) till the time vaccine is injected to the end-users which are normally infants in case of Measles. The purpose of the present study was the estimation of the thermal stability of the vaccine using three different types of stabilizers for lyophilization. All batches were prepared using different types (ST, SH & SG) of stabilizer and tested in triplicate against reference according to WHO's method of Spearman-Karber for calculation of vaccine titer. Potency and accelerated stability were carried out by incubating each of the three vaccines at 2-4oC and 37oC for seven days. For calculation of potency drop at increasing temperatures, titer was calculated for consecutive fourteen days at 24 hours interval, three vials from each vaccine type were incubated at 4oC, 25oC, 37oC, and 41oC. The potency observed was between log 103.64 to 104.89. Thus, making them fall within the WHO laid down criteria. These potency results also demonstrated that ST based stabilizer was comparatively more stable among the three. It also verified that vaccine remains stable for 14 days at 37oC but rapidly loses potency at 41oC even after 4 days. This study verifies that regardless of external hard weather conditions (e.g., Pakistan), maintenance of manufacturer recommended storage temperature and effective use of proper stabilizer is the only way to ensure the stability of the measles vaccine.

Page(s): 29-36

DOI: DOI not available

Published: Journal: Proceedings of the Pakistan Academy of Sciences: B. Life and Environmental Sciences, Volume: 57, Issue: 1, Year: 2020

Keywords:

Storage , Quality control , Measles virus , Heatstable , Potency , Stabilizers

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