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Retention characteristics of sterile filters – Effect of pore size and structure.

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Title: Retention characteristics of sterile filters – Effect of pore size and structure.
Authors: Taylor, Neil1 (AUTHOR), Ma, Wanli Justin2 (AUTHOR), Kristopeit, Adam2 (AUTHOR), Wang, Sheng-ching2 (AUTHOR), Zydney, Andrew L.1 (AUTHOR) zydney@engr.psu.edu
Source: Journal of Membrane Science. Oct2021, Vol. 635, pN.PAG-N.PAG. 1p.
Subjects: Recombinant proteins, Scanning electron microscopy, Gene therapy, Pore size distribution, Viral vaccines, Zika virus
Abstract: Sterile filtration is used to remove microorganisms in the processing of most recombinant proteins, but there are significant challenges in applying this technology to large biotherapeutics like Live-Attenuated Vaccines (LAV), lipid-nanoparticles, and gene therapy agents. Previous studies have reported highly variable fouling and product retention behavior of different sterile filters in these applications, but there has been no clear understanding of the origin of these differences. This study used fluorescently-labeled 200, 300, and 400 nm polystyrene latex spheres as model particle challenges for eight commercially available, 0.2/0.22 μm pore size sterile filters, all of which were characterized using mercury intrusion porosimetry, bubble point measurements, and scanning electron microscopy. All filters showed significant fouling, causing an increase in particle retention at high throughput. The maximum transmission of the 300 nm particles varied from only 0.01 for the highly asymmetric Millipore Express® to 0.9 for the dual-layer Sartobran® P. The transmission was well correlated with the ratio of the particle diameter to the maximum pore size (determined by bubble point), with even better agreement obtained using the mean pore size evaluated from mercury intrusion porosimetry. These results provide important insights into the effects of pore size and structure on the retention characteristics of sterile filter as well as guidance on how to select the best sterile filters for processing vaccines and viruses that are >100 nm in size. [Display omitted] • Nanoparticle retention evaluated for range of commercial 0.2 μm sterile filters. • Transmission of 300 nm particles varied between 1% and >90%. • Filters characterized by bubble point and mercury porometry. • Differences in transmission directly related to small differences in pore size. • Particle fouling resulted in decrease in transmission at high throughput. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Membrane Science is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Engineering Source
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Header DbId: egs
DbLabel: Engineering Source
An: 151194496
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Retention characteristics of sterile filters – Effect of pore size and structure.
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  Data: <searchLink fieldCode="AR" term="%22Taylor%2C+Neil%22">Taylor, Neil</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ma%2C+Wanli+Justin%22">Ma, Wanli Justin</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kristopeit%2C+Adam%22">Kristopeit, Adam</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wang%2C+Sheng-ching%22">Wang, Sheng-ching</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zydney%2C+Andrew+L%2E%22">Zydney, Andrew L.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> zydney@engr.psu.edu</i>
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  Data: <searchLink fieldCode="DE" term="%22Recombinant+proteins%22">Recombinant proteins</searchLink><br /><searchLink fieldCode="DE" term="%22Scanning+electron+microscopy%22">Scanning electron microscopy</searchLink><br /><searchLink fieldCode="DE" term="%22Gene+therapy%22">Gene therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Pore+size+distribution%22">Pore size distribution</searchLink><br /><searchLink fieldCode="DE" term="%22Viral+vaccines%22">Viral vaccines</searchLink><br /><searchLink fieldCode="DE" term="%22Zika+virus%22">Zika virus</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Sterile filtration is used to remove microorganisms in the processing of most recombinant proteins, but there are significant challenges in applying this technology to large biotherapeutics like Live-Attenuated Vaccines (LAV), lipid-nanoparticles, and gene therapy agents. Previous studies have reported highly variable fouling and product retention behavior of different sterile filters in these applications, but there has been no clear understanding of the origin of these differences. This study used fluorescently-labeled 200, 300, and 400 nm polystyrene latex spheres as model particle challenges for eight commercially available, 0.2/0.22 μm pore size sterile filters, all of which were characterized using mercury intrusion porosimetry, bubble point measurements, and scanning electron microscopy. All filters showed significant fouling, causing an increase in particle retention at high throughput. The maximum transmission of the 300 nm particles varied from only 0.01 for the highly asymmetric Millipore Express® to 0.9 for the dual-layer Sartobran® P. The transmission was well correlated with the ratio of the particle diameter to the maximum pore size (determined by bubble point), with even better agreement obtained using the mean pore size evaluated from mercury intrusion porosimetry. These results provide important insights into the effects of pore size and structure on the retention characteristics of sterile filter as well as guidance on how to select the best sterile filters for processing vaccines and viruses that are >100 nm in size. [Display omitted] • Nanoparticle retention evaluated for range of commercial 0.2 μm sterile filters. • Transmission of 300 nm particles varied between 1% and >90%. • Filters characterized by bubble point and mercury porometry. • Differences in transmission directly related to small differences in pore size. • Particle fouling resulted in decrease in transmission at high throughput. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Journal of Membrane Science is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1016/j.memsci.2021.119436
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      – Code: eng
        Text: English
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      – SubjectFull: Recombinant proteins
        Type: general
      – SubjectFull: Scanning electron microscopy
        Type: general
      – SubjectFull: Gene therapy
        Type: general
      – SubjectFull: Pore size distribution
        Type: general
      – SubjectFull: Viral vaccines
        Type: general
      – SubjectFull: Zika virus
        Type: general
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      – TitleFull: Retention characteristics of sterile filters – Effect of pore size and structure.
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            NameFull: Taylor, Neil
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            NameFull: Ma, Wanli Justin
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            NameFull: Kristopeit, Adam
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              M: 10
              Text: Oct2021
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              Y: 2021
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              Value: 635
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