Journal
BIOTECHNOLOGY AND BIOENGINEERING
Volume 118, Issue 1, Pages 106-115Publisher
WILEY
DOI: 10.1002/bit.27554
Keywords
fouling; live-attenuated virus; sterile filtration; vaccine; virus-like particle
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Funding
- Merck Sharp and Dohme [PSU-2019]
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This study examines the performance of several commercial sterile filters for filtration of a cytomegalovirus vaccine candidate and uses a model nanoparticle suspension for a quantitative assessment. The results show that the Sartorius Sartobran P filter performs well, providing over 80% yield of both the vaccine and model particles at different particle concentrations.
There is growing interest in the development of new vaccines based on live-attenuated viruses (LAVs) and virus-like particles. The large size of these vaccines, typically 100-400 nm, significantly complicates the use of sterile filtration. The objectives of this study are to examine the performance of several commercial sterile filters for filtration of a cytomegalovirus vaccine candidate (referred to as the LAV) and to develop and evaluate the use of a model nanoparticle suspension to perform a more quantitative assessment. Data obtained with a mixture of 200- and 300-nm fluorescent particles provided yield and pressure profiles that captured the behavior of the viral vaccine. This included the excellent performance of the Sartorius Sartobran P filter, which provided greater than 80% yield of both the vaccine and model particles even though the average particle size was more than 250 nm. The particle yield for the Sartobran P was independent of filtrate flux above 200 L/m(2)/h, but increased with increasing particle concentration, varying from less than 10% at concentrations around 10(7) particles/ml to more than 80% at concentrations above 10(10) particles/ml due to saturation of particle capture/binding sites within the filter. These results provide important insights into the factors controlling transmission and fouling during sterile filtration of large vaccine products.
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