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β-Propiolactone, its application and assay methods
Seyedeh Zohreh Mirjalili1, Reyhaneh Sabourian1, Fatemeh Chavoshi1
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Analytical Methods : Advancing Methods and Applications
|September 22, 2025
Summary
Vaccine production uses beta-propiolactone (BPL) for viral inactivation, but residual BPL is a safety concern. This review compares analytical methods like GC and HPLC to ensure BPL removal for safe vaccines.
Area of Science:
- Biotechnology
- Vaccinology
- Analytical Chemistry
Background:
- Vaccines are vital for preventing infectious diseases.
- Viral deactivation is a key vaccine production step.
- Beta-propiolactone (BPL) is used for viral inactivation due to its ability to preserve immunogenicity.
Purpose of the Study:
- To review viral inactivation methods, focusing on BPL.
- To highlight the importance of detecting residual BPL in vaccines.
- To compare analytical techniques for BPL quantification.
Main Methods:
- Review of literature on viral inactivation and BPL.
- Analysis of gas chromatography (GC) and high-performance liquid chromatography (HPLC) for BPL detection.
- Comparison of advantages and limitations of different analytical methods.
Main Results:
- BPL is effective for viral inactivation but poses safety risks due to its carcinogenic potential.
- Accurate quantification of residual BPL is crucial for vaccine safety.
- GC and HPLC are effective methods for measuring BPL, each with specific pros and cons.
Conclusions:
- Ensuring complete removal of BPL is essential for vaccine safety.
- Analytical methods like GC and HPLC are critical for quality control in vaccine manufacturing.
- This review provides insights into selecting appropriate methods for residual BPL detection.
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