β-propiolactone, Its Application and Assay Methods

Abstract

Vaccination is a crucial tool in the prevention of infectious diseases and has saved countless lives worldwide. One of the most commonly used techniques for producing vaccines is viral deactivation. β-propiolactone (BPL) is an agent used to inactivate and sterilize biological products, including vaccines. BPL is favored for its ability to preserve virus capsid proteins and maintain high immunogenicity. However, BPL is an alkylating agent with potential carcinogenic properties, making it unacceptable for residual amounts to be present in the final vaccine product. Therefore, it is necessary to eliminate any trace amounts of BPL remaining after the inactivation process to ensure vaccine safety. This review aims to discuss different methods of viral inactivation, with a specific focus on BPL, and emphasize the necessity of accurately measuring its presence. The advantages and limitations of various analytical techniques that have proven effective in quantifying BPL, with a primary focus on gas chromatography (GC) and high-performance liquid chromatography (HPLC) are compared. These methods discussed in this paper offer valuable insights for quality control in vaccine production, ensuring product safety for patients.