Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD

Jorba, Nuria; Shitanishi, Kenneth T.; Winkler, Clint J.; Herring, Steven W.

doi:10.1016/j.biologicals.2014.06.002

Cited by 5 publications

(6 citation statements)

References 10 publications

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“…For virus filtration, the main performance parameters for evaluating robustness are product capacity and viral clearance capability, while the major sources of variability are variations in feedstock, differences in filter lots, and ranges of operating parameters. Many case studies have demonstrated the robustness of virus filtration processes even with variation in solution conditions and under wide ranges of operating parameters . For example, studies using Planova™ 20N and BioEX filters have shown high product capacity and virus removal over wide ranges of protein concentration, ionic strength and pH .…”

Section: Introductionmentioning

confidence: 99%

Characterizing the impact of pressure on virus filtration processes and establishing design spaces to ensure effective parvovirus removal

Strauss

Goldstein

Hongo‐Hirasaki

et al. 2017

Biotechnology Progress

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Virus filtration provides robust removal of potential viral contaminants and is a critical step during the manufacture of biotherapeutic products. However, recent studies have shown that small virus removal can be impacted by low operating pressure and depressurization. To better understand the impact of these conditions and to define robust virus filtration design spaces, we conducted multivariate analyses to evaluate parvovirus removal over wide ranges of operating pressure, solution pH, and conductivity for three mAb products on Planova TM BioEX and 20N filters. Pressure ranges from 0.69 to 3.43 bar (10.0-49.7 psi) for Planova BioEX filters and from 0.50 to 1.10 bar (7.3 to 16.0 psi) for Planova 20N filters were identified as ranges over which effective removal of parvovirus is achieved for different products over wide ranges of pH and conductivity. Viral clearance at operating pressure below the robust pressure range suggests that effective parvovirus removal can be achieved at low pressure but that Minute virus of mice (MVM) logarithmic reduction value (LRV) results may be impacted by product and solution conditions. These results establish robust design spaces for Planova BioEX and 20N filters where high parvovirus clearance can be expected for most antibody products and provide further understanding of viral clearance mechanisms.

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Section: Introductionmentioning

confidence: 99%

Characterizing the impact of pressure on virus filtration processes and establishing design spaces to ensure effective parvovirus removal

Strauss

Goldstein

Hongo‐Hirasaki

et al. 2017

Biotechnology Progress

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“…Small viruses passing the ultrafiltration membrane will be retained at the nanofiltration step, which represents a CCP in the process. The ability of nanofiltration to remove viruses when they are spiked into laboratory models that mimic industrial-scale nanofiltration conditions has been shown (Jorba et al, 2014).…”

Section: Assessment Of the Level Of Risk Reduction By The Biohaz Panelmentioning

confidence: 99%

Evaluation of the application for a new alternative processing method for animal by‐products of Category 3 material (ChainCraft B.V.)

Ricci¹,

Allende²,

Bolton³

et al. 2018

EFS2

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EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method for treatment of Category 3 animal by‐products (ABP). It consists of the hydrolysis of the material to short‐carbon chains, resulting in medium‐chain fatty acids that may contain up to 1% hydrolysed protein, for use in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, is also used. Process efficacy has been evaluated based on the ability of the membrane barriers to retain potential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained at the nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requires the Applicant to validate and provide certification for the specific use of the nanofiltration membranes used. Continuous monitoring and membrane integrity tests should be included as control measures in the HACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size of virus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, the processing methods proposed should reduce the risk in the end product to a degree which is at least equivalent to that achieved with the processing standards laid down in the Regulation for Category 3 material. The possible presence of small bacterial toxins produced during the fermentation steps cannot be avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in the process. The limitations specified in the current legislation and any future modifications in relation to the end use of the product also apply to this alternative process, and no hydrolysed protein of ruminant origin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture.

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“…Nanofiltration is attractive because it is capable of physically removing all types of viruses from protein solution as opposed to virus inactivation. Several authors have described the application of virus removal nanofiltration for FIX industrial products using Planova 15/20/35N [9][10][11][12][13][14][15], Viresolve NFP [11,[16][17][18][19], and Ultipor DV50 filters [2]. The conclusion of these studies is that filtration of plasma-derived FIX-rich products is challenging due to the presence of large molecular weight impurities and protein aggregates.…”

Section: Introductionmentioning

confidence: 99%

“…The α-chains are responsible for binding C4b, while the β-chain has high-affinity for VN (protein S), forming large complexes [22,25]. The molecular conformation of C4BP is highly dependent on the surrounding medium composition [11,19]. In the charged state the α-chains repel each other, thereby occupying much larger volume than the same molecule in the uncharged state.…”

Section: Introductionmentioning

confidence: 99%

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Two-Step Size-Exclusion Nanofiltration of Prothrombin Complex Concentrate Using Nanocellulose-Based Filter Paper

Manukyan

Mantas

Razumikhin³

et al. 2020

Biomedicines

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Coagulation Factor IX-rich protrhombin complex concentrate (FIX-PCC) is a therapeutic biologic product that consists of a mixture of several human plasma-derived proteins, useful for treating hemophilia B. Due to its complex composition, FIX-PCC is very challenging to bioprocess through virus removing nanofilters in order to ensure its biosafety. This article describes a two-step filtration process of FIX-PCC using a nanocellulose-based filter paper with tailored porosity. The filters were characterized with scanning electron microscopy (SEM), cryoporometry with differential scanning calorimetry, and nitrogen gas sorption. Furthermore, in order to probe the filter’s cut-off size rejection threshold, removal of small- and large-size model viruses, i.e., ΦX174 (28 nm) and PR772 (70 nm), was evaluated. The feed, pre-filtrate, and permeate solutions were characterized with mass-spectrometric proteomic analysis, dynamic light scattering (DLS), sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), and analytical size-exclusion high-performance liquid chromatography (SEHPLC). By sequential filtration through 11 μm pre-filter and 33 μm virus removal filter paper, it was possible to achieve high product throughput and high virus removal capacity. The presented approach could potentially be applied for bioprocessing other protein-based drugs.

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Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD

Cited by 5 publications

References 10 publications

Characterizing the impact of pressure on virus filtration processes and establishing design spaces to ensure effective parvovirus removal

Characterizing the impact of pressure on virus filtration processes and establishing design spaces to ensure effective parvovirus removal

Evaluation of the application for a new alternative processing method for animal by‐products of Category 3 material (ChainCraft B.V.)

Two-Step Size-Exclusion Nanofiltration of Prothrombin Complex Concentrate Using Nanocellulose-Based Filter Paper

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