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

Taylor, Neil W.; Ma, Wanli; Kristopeit, Adam; Wang, Sheng-ching; Zydney, Andrew L.

doi:10.1016/j.memsci.2021.119436

Cited by 19 publications

(10 citation statements)

References 22 publications

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“…hypothesized that high particle yield and loading capacity of the 0.2 µm dual‐layer Sartobran P filter was due to the 0.45 µm cellulose acetate pre‐filter and relatively large mean pore size compared to other similar, commercially available sterile filters. [ 45,46 ] These results further indicate that factors other than pore size have an impact on filtration yield (Figure 7A).…”

Section: Resultsmentioning

confidence: 60%

Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS‐CoV‐2

Kuczynski,

Shallow,

Watson

et al. 2023

Biotechnology Journal

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During the COVID‐19 pandemic, long development timelines typically associated with vaccines were challenged. The urgent need for a vaccine provided a strong driver to reevaluate existing vaccine development approaches. Innovative approaches to regulatory approval were realized, including the use of platform‐based technology. In collaboration with the International AIDS Vaccine Initiative, Inc. (IAVI), Merck & Co., Inc., Rahway, NJ, USA rapidly advanced an investigational SARS‐CoV‐2 vaccine based on the recombinant vesicular stomatitis virus (rVSV) platform used for the Ebola vaccine ERVEBO (rVSV∆G‐ZEBOV‐GP). An rVSV∆G‐SARS‐CoV‐2 vaccine candidate was generated using the SARS‐CoV‐2 spike protein to replace the VSV G protein. The purification process development for this vaccine candidate was detailed in this paper. Areas were highlighted where the ERVEBO platform process was successfully adopted and where additional measures were needed for the SARS‐CoV‐2 vaccine candidate. These included: (i) endonuclease addition directly into the bioreactor prior to harvest, (ii) inclusion of a core‐shell chromatography step for improved purification, and (iii) incorporation of a terminal, sterile filtration step to eliminate the need for aseptic, closed processing. High infectious virus titers were achieved in Phase 3 clinical drug substance (>108 PFU mL−1), and process consistency was demonstrated across four large scale batches that were completed in 6 months from clone selection.

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Section: Resultsmentioning

confidence: 60%

Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS‐CoV‐2

Kuczynski,

Shallow,

Watson

et al. 2023

Biotechnology Journal

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“…Tighter membranes (smaller pore sizes) equate to slower permeate flow rate across the membrane, and membrane pore size selection is ultimately a trade-off between the processing cycle time and product recovery. Regardless, membranes should be chosen with a pore size smaller than the size of the species to be retained, ensuring higher retention of the target molecule. − …”

Section: Membrane and Materials Selectionmentioning

confidence: 99%

A Review of Tangential Flow Filtration: Process Development and Applications in the Pharmaceutical Industry

Agrawal

Wilkstein

Guinn

et al. 2023

Org. Process Res. Dev.

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Tangential flow filtration is an efficient membrane separation technology utilized across a wide range of industries for separation and purification applications. The requirement of telescoped manufacturing to produce high-volume drugs in the pharmaceutical industry has led to increased adoption of membrane separation for drug substance synthesis. Particularly, for noncrystalline molecules with limited product stability and significant thermal liabilities, TFF is a powerful alternative to traditional isolation techniques. This Review discusses the various considerations during the development of a TFF process and highlights applications of TFF to produce pharmaceutically relevant molecules such as proteins, peptides, monoclonal antibodies, and so on. Finally, a future perspective on the technology is shared for improved performance.

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“…The lowest capacity and yield were obtained with the Millipore Express which had the highest bubble point (smallest maximum pore size) of any of the sterile filters. [ 9 ] In contrast, Fallahianbijan et al. [ 10 ] found that the Millipore Express had the greatest capacity during sterile filtration of a vaccine drug substance containing a single glycoconjugate serotype.…”

Section: Introductionmentioning

confidence: 99%

Filtration of a multi‐serotype glycoconjugate vaccine drug product through sterilizing grade 0.2/0.22 µm pore size filters

Du,

Qiu,

Gill

et al. 2024

Biotechnology Journal

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Glycoconjugate vaccines containing multiple serotypes of a bacterial capsular polysaccharide can provide strong immune protection against pathogenic infections. Sterile filtration is an important component of the fill and finish operations in the preparation of these vaccines, with the capacity of the sterile filter limited by membrane fouling. The objective of this study was to examine the performance of a range of commercial 0.2/0.22 µm nominal pore size sterilizing grade filters with both single‐layer and dual‐layer structures during filtration of a glycoconjugate vaccine drug product consisting of four polysaccharide serotypes. The highly asymmetric Millipore Express showed much higher capacity than the more homogeneous filters, with the support structure of the Express acting as a prefilter that was able to remove foulants thereby protecting the small pores in the size‐selective skin layer. This behavior was confirmed by performing experiments with different batch prefilters and by examining the location of foulant deposition within the sterile filters using confocal microscopy. These results provide important insights into the factors controlling fouling by these multiserotype vaccines as well as a framework for increasing the capacity of the sterile filter.

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

Cited by 19 publications

References 22 publications

Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS‐CoV‐2

Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS‐CoV‐2

A Review of Tangential Flow Filtration: Process Development and Applications in the Pharmaceutical Industry

Filtration of a multi‐serotype glycoconjugate vaccine drug product through sterilizing grade 0.2/0.22 µm pore size filters

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