Sindbis virus as a tool for quality control of viral inactivation of heated and chemically treated plasma-derived products

Espíndola, Otávio de Melo; Belluci, M.S.P.; Oliveira, Barbara Cristina Euzébio Pereira Dias de; Liberto, Maria Isabel Madeira; Cabral, M. C.

doi:10.1016/j.jviromet.2006.01.001

Cited by 7 publications

(5 citation statements)

References 26 publications

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“…For all detergent‐mediated VI conditions tested with the exception of DDM 10 × CMC, HSV‐1 showed greater inactivation than either A‐MuLV or X‐MuLV (Figure 6). No inactivation was observed for any of the viruses in the presence of Polysorbate 80, which is commonly employed for solvent‐detergent inactivation of plasma‐derived products (Espíndola et al, 2006). Only HSV‐1 in Fus1 shows inactivation >4.0 LRV for sodium taurocholate at 1 × CMC.…”

Section: Resultsmentioning

confidence: 99%

Assessing detergent‐mediated virus inactivation, protein stability, and impurity clearance in biologics downstream processes

Feroz

Chennamsetty

Byers

et al. 2022

Biotech & Bioengineering

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Detergent‐mediated virus inactivation (VI) provides a valuable orthogonal strategy for viral clearance in mammalian processes, in particular for next‐generation continuous manufacturing. Furthermore, there exists an industry‐wide need to replace the conventionally employed detergent Triton X‐100 with eco‐friendly alternatives. However, given Triton X‐100 has been the gold standard for VI due its minimal impact on protein stability and high inactivation efficacy, inactivation by other eco‐friendly detergents and its impact on protein stability is not well understood. In this study, the sugar‐based detergent commonly used in membrane protein purification, n‐dodecyl‐β‐ d‐maltoside was found to be a promising alternative for VI. We investigated a panel of detergents to compare the relative VI efficacy, impact on therapeutic quality attributes, and clearance of the VI agent and other impurities through subsequent chromatographic steps. Detergent‐mediated inactivation and protein stability showed comparable trends to low pH inactivation. Using experimental and modeling data, we found detergent‐mediated product aggregation and its kinetics to be driven by extrinsic factors such as detergent and protein concentration. Detergent‐mediated aggregation was also impacted by an initial aggregation level as well as intrinsic factors such as the protein sequence and detergent hydrophobicity, and critical micelle concentration. Knowledge gained here on factors driving product stability and VI provides valuable insight to design, standardize, and optimize conditions (concentration and duration of inactivation) for screening of detergent‐mediated VI.

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Section: Resultsmentioning

confidence: 99%

Assessing detergent‐mediated virus inactivation, protein stability, and impurity clearance in biologics downstream processes

Feroz

Chennamsetty

Byers

et al. 2022

Biotech & Bioengineering

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“…It has a reported pI of 4.2 [ 49 ]. Sindbis virus is also not easily inactivated by mild solvent-detergent [ 50 ], due to it having the highest cholesterol and saturated lipid content of the enveloped virus family. Its structure and composition are similar to flaviviruses (for example, hepatitis C, Yellow fever, and dengue virus), all of which cause global public health emergencies [ 51 ].…”

Section: Resultsmentioning

confidence: 99%

Virus and chlorine adsorption onto guanidine modified cellulose nanofibers using covalent and hydrogen bonding

Albukhari

Heldt

et al. 2020

Carbohydrate Research

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Unsafe drinking water leads to millions of human deaths each year, while contaminated wastewater discharges are a significant threat to aquatic life. To relieve the burden of unsafe water, we are in search of an inexpensive material that can adsorb pathogenic viruses from drinking water and adsorb toxic residual chlorine from wastewater. To impart virus and chlorine removal abilities to cellulosic materials, we modified the primary hydroxyl group with a positively charged guanidine group, to yield guanidine modified cellulose derivatives. Microcrystalline cellulose (MC) bearing covalently bonded guanidine hydrochloride (MC-G C ) and hydrogen-bonded guanidine hydrochloride (MC-G H ) were synthesized, and electrospun into nanofibers after blending with the non-ionogenic polyvinyl alcohol (PVA), to produce large pore sized, high surface area membranes. The MC-G C /PVA and MC-G H /PVA nanofibers were stabilized against water dissolution by crosslinking with glutaraldehyde vapor. The water-stable MC-G C /PVA mats were able to remove more than 4 logs of non-enveloped porcine parvovirus (PPV) and enveloped Sindbis virus and reached 58% of chlorine removal. The MC-G C /PVA nanofibers demonstrated better performance for pathogen removal and dechlorination than MC-G H /PVA nanofibers. This first study of MC-G C /PVA electrospun mats for virus removal shows they are highly effective and merit additional research for virus removal.

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“…Remarkably, the inactivation of SINV was far less efficient in lyophilized and reconstituted VIII concentrates when compared to PBS controls. Thus, the results emphazise the relevance of testing stabilizing agents in inactivation studies [25].…”

Section: Discussionmentioning

confidence: 99%

“…Established methods for the inactivation or removal of viral pathogens in plasma pools include pasteurization—10 h at 60 °C—, solvent/detergent (S/D) treatment and virus retentive filtration (nanofiltration). Only a few studies investigating the inactivation of alphaviruses including CHIKV, Sindbis virus (SINV) and SFV in PDMPs by heat or S/D treatment have been published [21,22,23,24,25,26,27,28,29]. In this study, we investigated the inactivation/removal of MAYV and CHIKV by heat inactivation in different matrices such as medium and albumin solutions.…”

Section: Introductionmentioning

confidence: 99%

Inactivation and Removal of Chikungunya Virus and Mayaro Virus from Plasma-derived Medicinal Products

Yue

Teitz

Miyabashi

et al. 2019

Viruses

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Background: Chikungunya virus (CHIKV) and Mayaro virus (MAYV) are closely related members of the Semliki Forest complex within the genus alphavirus and are transmitted by arthropods, causing acute febrile illness in humans. CHIKV has spread to almost all continents, whereas autochthonous MAYV infections have been reported in South America and in the Caribbean. Nevertheless, there was concern about potential spread of MAYV to other regions similar to CHIKV in the past. The risk for transmission of emerging viruses by blood transfusion and the safety of plasma-derived medicinal products (PDMPs) are constant concerns. The manufacturing processes of PDMPs include procedures to inactivate/remove viruses. Methods: In this study, we investigated the reduction of MAYV and CHIKV by heat inactivation in various matrices, solvent/detergent treatment and nanofiltration. Results: Unexpectedly, MAYV was significantly more resistant to heat and solvent/detergent treatment compared to CHIKV. However, being similar in size, both MAYV and CHIKV were removed below the detection limit by 35 nm virus filters. Conclusions: The inactivation profiles of different alphavirus members vary considerably, even within the Semliki Forest Complex. However, robust dedicated viral inactivation/removal procedures commonly used in the plasma product industry are effective in inactivating or removing MAYV and CHIKV.

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Sindbis virus as a tool for quality control of viral inactivation of heated and chemically treated plasma-derived products

Cited by 7 publications

References 26 publications

Assessing detergent‐mediated virus inactivation, protein stability, and impurity clearance in biologics downstream processes

Assessing detergent‐mediated virus inactivation, protein stability, and impurity clearance in biologics downstream processes

Virus and chlorine adsorption onto guanidine modified cellulose nanofibers using covalent and hydrogen bonding

Inactivation and Removal of Chikungunya Virus and Mayaro Virus from Plasma-derived Medicinal Products

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