Effect of antibody solution conditions on filter performance for virus removal filter Planova™ 20N

Hongo‐Hirasaki, Tomoko; Komuro, Masayasu; Ide, Shoichi

doi:10.1002/btpr.415

Cited by 38 publications

(63 citation statements)

References 24 publications

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“…Our model IgG solution contained about 4% IgG aggregate (dimer) in a concentration of 5 mg/mL, as proved by high‐performance size‐exclusion chromatography (HPLC‐SEC),22 corresponding to a 200 μg/mL concentration of the IgG dimer. For Planova™ 20N, the filterability under this condition (5 mg/mL IgG) was not influenced by the IgG dimer content, as reported in our previous study 22. And it is considered that plugging component derived from serum or host cell may be larger size of IgG dimer.…”

Section: Resultsmentioning

confidence: 98%

Effects of varying virus‐spiking conditions on a virus‐removal filter Planova™ 20N in a virus validation study of antibody solutions

Hongo‐Hirasaki

Yamaguchi

Yanagida

et al. 2011

Biotechnology Progress

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We aimed to investigate the effect of virus-spiking conditions on the filter performance (flux, flux decay, and parvovirus reduction) of the small virus filter Planova™ 20N. We used three kinds of porcine parvovirus (PPV) stocks: serum, serum-free, and purified. The flux profile with PPV spiking was similar to that without spiking for normal load filtration of about 250-300 L/m(2) . High volume (3 vol %) of serum-free PPV and 1 vol % serum PPV reduced the flux to some extent for high-load filtration (over 10 h, ca., 500 L/m(2) , 5 mg/mL IgG solution). Log reduction value (LRV) of PPV was maintained at a high level (>5) over the filtration volume. Flux for Planova™ 20N was only minimally affected by the use of different virus stocks for spiking. Transmission electron microphotography showed that the distribution of PPV particles captured inside the membrane wall was reached until the -60% thickness of the membrane, showing that the membrane of Planova™ 20N has a thick effective layer for virus removal. These results provided evidence for the robustness of the filter performance of Planova™ 20N, showing that it was not easily affected by virus spiking conditions and that it has a large capacity for high-load conditions.

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Section: Resultsmentioning

confidence: 98%

Effects of varying virus‐spiking conditions on a virus‐removal filter Planova™ 20N in a virus validation study of antibody solutions

Hongo‐Hirasaki

Yamaguchi

Yanagida

et al. 2011

Biotechnology Progress

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“…Previous studies (Bakhshayeshi & Zydney, 2008; G. R. Bolton, Spector, & LaCasse, 2006;Dishari et al, 2015;Hongo-Hirasaki, Komuro, & Ide, 2010;Rayfield et al, 2015;Wickramasinghe, Stump, Grzenia, Husson, & Pellegrino, 2010) show that buffer conditions, including pH, buffer type, and ionic strength could affect the filtration performance of the virus filters. In addition, earlier studies have shown that the performance of virus filters is also dependent on the specific protein in the feed (Stuckey et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

The effects of buffer condition on the fouling behavior of MVM virus filtration of an Fc‐fusion protein

Namila

Traylor

et al. 2019

Biotech & Bioengineering

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A combined pore blockage and cake filtration model was applied to the virus filtration of an Fc-fusion protein using the three commercially available filters, F-1, F-2, and F-3 in a range of buffer conditions including sodium-phosphate and tris-acetate buffers with and without 200 mM NaCl at pH 7.5. The fouling behaviors of the three filters for the feed solutions spiked with minute virus of mice were described well by this combined model for all the solution conditions. This suggests that fouling of the virus filters is dominated by the pore blockage mechanism during the initial stage of the filtration and transformed to the cake filtration mechanism during the later stage of the filtration. Both flux and transmembrane resistance can be described well by this model. The pore blockage rate and the rate of increase of protein layer resistance over blocked pores are found to be affected by membrane properties as well as the solution conditions resulting from the modulation of interactions between virus, protein, and membrane by the solution conditions. K E Y W O R D S cake filtration, Fc-fusion protein, pore blocking model, solution conditions, virus filtration SUPPORTING INFORMATION Additional supporting information may be found online in the Supporting Information section. How to cite this article: Namila F, Zhang D, Traylor S, et al. The effects of buffer condition on the fouling behavior of MVM virus filtration of an Fc-fusion protein. Biotechnology and

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“…Therefore, when designing any viral filtration into a continuous flow‐through process, product specific factors, such as buffer pH, conductivity, pressure, or flow rates and their effect on viral filter retention must be considered. Potential frameworks for these considerations exist for batch processing (Bolton et al, ; Dishari et al, ; Hongo‐Hirasaki et al, ) that may be utilized in designing continuous viral filtration methods or when performing validation studies. As with batch processing methods, integrating any novel or adapted viral filtration into a continuous flow‐through polishing process will require validation of clearance, but often this can be performed as an isolated unit in batch mode.…”

Section: Viral Filtrationmentioning

confidence: 99%

Adapting viral safety assurance strategies to continuous processing of biological products

Johnson

Brown

Lute

et al. 2016

Biotech & Bioengineering

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There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. However, in many of these proposed continuous processing model systems, viral safety has not been comprehensively addressed. Viral safety and detection is a highly important and often expensive regulatory requirement for any new biological product. To ensure success in the adaption of continuous processing to large-scale production, there is a need to consider the development of approaches that allow for seamless incorporation of viral testing and clearance/inactivation methods. In this review, we outline potential strategies to apply current viral testing and clearance/inactivation technologies to continuous processing, as well as modifications of existing unit operations to ensure the successful integration of viral clearance into the continuous processing of biological products. Biotechnol. Bioeng. 2017;114: 21-32. © 2016 Wiley Periodicals, Inc.

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Effect of antibody solution conditions on filter performance for virus removal filter Planova™ 20N

Cited by 38 publications

References 24 publications

Effects of varying virus‐spiking conditions on a virus‐removal filter Planova™ 20N in a virus validation study of antibody solutions

Effects of varying virus‐spiking conditions on a virus‐removal filter Planova™ 20N in a virus validation study of antibody solutions

The effects of buffer condition on the fouling behavior of MVM virus filtration of an Fc‐fusion protein

Adapting viral safety assurance strategies to continuous processing of biological products

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