Bacterial Retention During Filtration of a Live Attenuated Virus Vaccine Through the Sartobran P Sterile Filter

Recent studies of sterile filtration of a Live Attenuated Virus (LAV) demonstrated that the Sartobran P sterile filter provided 80% yield of a LAV that was 100 – 400 nm in size, raising questions about the effectiveness of this filter in retaining the standard challenge bacterium, Brevundimonas diminuta. This study evaluated the retention of B. diminuta by the Sartobran P over a range of conditions appropriate for LAV filtration. The B. diminuta were characterized by dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), and scanning electron microscopy. The Sartobran P showed complete retention of B. diminuta under all conditions, even in the presence of additives like sucrose, surfactants, and high salt that have previously been hypothesized to increase the risk of bacterial breakthrough. The size of B. diminuta decreased when incubated in the nutrient poor media required by the ASTM challenge test. The addition of sucrose caused a further reduction in size as measured by NTA, although this was due to an increase in cell motility. There was no evidence of bacterial breakthrough at high loadings of either the LAV or B. diminuta, further demonstrating the effectiveness of the Sartobran P for sterile filtration of large viral vaccines.

© This manuscript version is made available under the CC-BY-NC-ND 4.0 license



Work Title Bacterial Retention During Filtration of a Live Attenuated Virus Vaccine Through the Sartobran P Sterile Filter
Open Access
  1. Neil Taylor
  2. Matt Morris
  3. Alex Wee
  4. Wanli (Justin) Ma
  5. Adam Kristopeit
  6. Sheng ching Wang
  7. Andrew L. Zydney
License CC BY-NC-ND 4.0 (Attribution-NonCommercial-NoDerivatives)
Work Type Article
  1. Journal of Pharmaceutical Sciences
Publication Date July 1, 2022
Publisher Identifier (DOI)
Deposited January 23, 2023




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Work History

Version 1

  • Created
  • Added Bacterial_retention_during_filtration.pdf
  • Added Creator Neil Taylor
  • Added Creator Matt Morris
  • Added Creator Alex Wee
  • Added Creator Wanli (Justin) Ma
  • Added Creator Adam Kristopeit
  • Added Creator Sheng ching Wang
  • Added Creator Andrew L. Zydney
  • Published
  • Updated