Fouling Behavior during Sterile Filtration of Different Glycoconjugate Serotypes Used in Conjugate Vaccines

Purpose: Sterile filtration can be a particular challenge when processing very large glycoconjugate vaccines. The objective of this study was to examine the sterile filtration performance of a series of glycoconjugate vaccines produced by coupling different polysaccharide serotypes to an immunogenic protein. Methods: Sterile filtration was performed at constant filtrate flux using 0.22 μm pore size Durapore® polyvinylidene fluoride membranes. Glycoconjugates were characterized by dynamic light scattering, rheological measurements, and nanoparticle tracking analysis (NTA). Confocal microscopy was used to examine glycoconjugate capture profiles within the membrane. Transmembrane pressure data were analyzed using a recently developed fouling model. Results: All glycoconjugates deposited in a narrow band near the entrance of the Durapore® membranes. The rate of fouling varied significantly for the different serotypes, with the fouling parameter correlated with the fraction of glycoconjugates larger than 200 nm in size. Conclusions: The fouling behavior and sterile filter capacity of the different glycoconjugate serotypes are determined primarily by the presence of large species (>200 nm in size) as determined by nanoparticle tracking analysis. The modified intermediate pore blockage model provides a framework for predicting the sterile filtration performance for these glycoconjugate vaccines.



Work Title Fouling Behavior during Sterile Filtration of Different Glycoconjugate Serotypes Used in Conjugate Vaccines
Open Access
  1. Parinaz Emami
  2. Fatemeh Fallahianbijan
  3. Erica Dinse
  4. Seyed Pouria Motevalian
  5. Brenda Carrillo Conde
  6. Kelvin Reilly
  7. Andrew L. Zydney
License In Copyright (Rights Reserved)
Work Type Article
  1. Pharmaceutical Research
Publication Date January 12, 2021
Publisher Identifier (DOI)
Deposited November 23, 2021




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Work History

Version 1

  • Created
  • Added Sterile_filtration-Different_serotypes-final2.docx
  • Added Creator Parinaz Emami
  • Added Creator Fatemeh Fallahianbijan
  • Added Creator Erica Dinse
  • Added Creator Seyed Pouria Motevalian
  • Added Creator Brenda Carrillo Conde
  • Added Creator Kelvin Reilly
  • Added Creator Andrew L. Zydney
  • Published
  • Updated
  • Updated