Evidence map›Paper›PMID 33438097›Full record

ArticlePharmaceutical research2021

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

Parinaz Emami, Fatemeh Fallahianbijan, Erica Dinse, Seyed Pouria Motevalian, Brenda Carrillo Conde, Kelvin Reilly, Andrew L Zydney

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Article in Pharmaceutical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

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0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Parinaz EmamiDepartment of Chemical Engineering, The Pennsylvania State University, University Park, PA, 16802, USA.
Fatemeh FallahianbijanDepartment of Chemical Engineering, The Pennsylvania State University, University Park, PA, 16802, USA.
Erica DinseDepartment of Chemical Engineering, The Pennsylvania State University, University Park, PA, 16802, USA.
Seyed Pouria MotevalianPfizer Inc., 1 Burtt Rd, Andover, MA, 01810, USA.
Brenda Carrillo CondePfizer Inc., 875 Chesterfield Village Parkway, Chesterfield, MO, 63017, USA.
Kelvin ReillyPfizer Inc., Grange Castle Business Park, Dublin, Clondalkin, Ireland.
Andrew L ZydneyDepartment of Chemical Engineering, The Pennsylvania State University, University Park, PA, 16802, USA. zydney@engr.psu.edu.ORCID http://orcid.org/0000-0003-1865-9156

Funding

Pfizer PSU-2018
6 · The paper itself

Abstract

purposeSterile 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.

methodsSterile 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.

resultsAll 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.

conclusionsThe 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.

Indexed as

Drug CompoundingDrug ContaminationFiltrationGlycoconjugatesMembranes, ArtificialMicropore FiltersParticle SizeVaccines, ConjugateGlycoconjugatesMembranes, ArtificialVaccines, Conjugatefoulingglycoconjugateserotypesterile filtrationvaccine

Identifiers

PMID33438097

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.