Challenges & opportunities in sterile filtration of vaccines

Sterile filtration plays a pivotal role in ensuring the safety of nearly all injectable drug products, including vaccines. One of the greatest challenges with sterile filtering many vaccines is the overlap in the size distributions of the vaccine particles and the pores of the sterile filter. The large size of mRNA vaccines, live attenuated viral vaccines, and glycoconjugate vaccines causes membrane fouling, significantly reducing both the overall filter capacity and vaccine recovery. Sterile filters with built-in prefilters, such as dual-layer filters, can be particularly attractive for processing these vaccine products. However, it is still not possible to predict the filtration performance for any given vaccine based on the sterile filter pore structure/morphology. This review highlights recent work analyzing the unique fouling behavior observed with different vaccine products, providing new insights into the design and optimization of the sterile filtration process.

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