Integrated viral clearance strategies — reflecting on the present, projecting to the future

Roush, David J.

doi:10.1016/j.copbio.2018.01.003

Cited by 12 publications

(10 citation statements)

References 42 publications

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“…Pathogen reduction of cell culture media prevents virus contaminations resulting from potential failures in the safety of raw materials and in good manufacturing practices, as has been seen in the biotech industry [68,69]. Technical options for the prevention of contamination of growth media include high-temperature short-time treatment and ultraviolet-C irradiation [70] or virus-filtration processes [71,72]. Conversely, nanofiltration of HPL-growth media implies specific measures at production scale including the creation of a dedicated virus-free area and specific working procedures intended to avoid the risks of downstream contaminations, as in the case, for instance, in the plasma fractionation industry.…”

Section: Discussionmentioning

confidence: 99%

Nanofiltration of growth media supplemented with human platelet lysates for pathogen-safe xeno-free expansion of mesenchymal stromal cells

et al. 2020

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Background aims: Human platelet lysate can replace fetal bovine serum (FBS) for xeno-free ex vivo expansion of mesenchymal stromal cells (MSCs), but pooling of platelet concentrates (PCs) increases risks of pathogen transmission. We evaluated the feasibility of performing nanofiltration of platelet lysates and determined the impact on expansion of bone marrowÀderived MSCs. Methods: Platelet lysates were prepared by freeze-thawing of pathogen-reduced (Intercept) PCs suspended in 65% storage solution (SPP+) and 35% plasma, and by serum-conversion of PCs suspended in 100% plasma. Lysates were added to the MSC growth media at 10% (v/v), filtered and subjected to cascade nanofiltration on 35-and 19-nm Planova filters. Media supplemented with 10% starting platelet lysates or FBS were used as the controls. Impacts of nanofiltration on the growth media composition, removal of platelet extracellular vesicles (PEVs) and MSC expansion were evaluated. Results: Nanofiltration did not detrimentally affect contents of total protein and growth factors or the biochemical composition. The clearance factor of PEVs was >3 log values. Expansion, proliferation, membrane markers, differentiation potential and immunosuppressive properties of cells in nanofiltered media were consistently better than those expanded in FBS-supplemented media. Compared with FBS, chondrogenesis and osteogenesis genes were expressed more in nanofiltered media, and there were fewer senescent cells over six passages. Conclusions: Nanofiltration of growth media supplemented with two types of platelet lysates, including one prepared from pathogen-reduced PCs, is technically feasible. These data support the possibility of developing pathogen-reduced xeno-free growth media for clinical-grade propagation of human cells.

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Section: Discussionmentioning

confidence: 99%

Nanofiltration of growth media supplemented with human platelet lysates for pathogen-safe xeno-free expansion of mesenchymal stromal cells

et al. 2020

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“…Virus inactivation technologies include physical (e.g., heat application, ultraviolet-and gamma irradiation) and chemical methods (e.g., low pH and solvent/detergent treatments) [3,188,190]. Virus removal is ensured by a combination of filtration and chromatography steps [3,12,191] (Fig. 4).…”

Section: Viral Clearancementioning

confidence: 99%

“…Overview of integrated adventitious agent control strategy. Adapted from[191] (with permission from Elsevier).…”

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confidence: 99%

Polysaccharide-based chromatographic adsorbents for virus purification and viral clearance

Junter

Lebrun

2020

Journal of Pharmaceutical Analysis

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“…Preventative measures against adventitious contamination involve viral inactivation of growth media, by high-temperature short-time treatment and ultraviolet-C irradiation. 47 Alternative methods involve medium nanofiltration. Indeed, some nano-filters for virus-filtration processes are used as a medium filter, and some dedicated medium filters are on the market.…”

Section: Pathogen Safetymentioning

confidence: 99%

<p>Extracellular Vesicles As Nanomedicine: Hopes And Hurdles In Clinical Translation</p>

Burnouf

Agrahari

2019

IJN

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The clinical development of cell therapies is revealing that extracellular vesicles (EVs) may become very instrumental as subcellular therapeutic adjuncts in human medicine. EVs are released by various types of cells, grown in culture, such as mesenchymal stromal cells, or obtained from patients or allogeneic donors. Some EV populations (especially species of exosomes and shed microvesicles) exhibit inherent roles in cell-cell communication, thanks to their ca. 30~1000-nm nanosize and the physiological expression of cellspecific markers on their lipid bilayer membranes. Biomedical engineers are now attempting to exploit this cellular crosstalk capacity to use EVs as smart drug delivery systems that display substantial benefits in targeting, safety, and pharmacokinetics compared to synthetic nanocarriers. In parallel, the development of a set of nano-instrumentation, biochemical tools, and preclinical assays needed for optimal characterization of both naïve and drugloaded EVs is ongoing. Although many hurdles remain, owing to the complexity of EV populations, translation of this "subcellular therapy" platform into reality is at hand and may soon change the landscape of the therapeutic arsenal in place to treat human degenerative and metabolic pathologies as well as diseases like cancer. This article provides objective opinions, balanced between unrealistic hopes of the capacity of EVs to resolve multiple clinical issues and concrete hurdles that have to be overcome to ensure that EVs are not lost in the translation phase, so that EVs can fulfill their promise by becoming a reliable therapeutic modality.

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Integrated viral clearance strategies — reflecting on the present, projecting to the future

Cited by 12 publications

References 42 publications

Nanofiltration of growth media supplemented with human platelet lysates for pathogen-safe xeno-free expansion of mesenchymal stromal cells

Nanofiltration of growth media supplemented with human platelet lysates for pathogen-safe xeno-free expansion of mesenchymal stromal cells

Polysaccharide-based chromatographic adsorbents for virus purification and viral clearance

<p>Extracellular Vesicles As Nanomedicine: Hopes And Hurdles In Clinical Translation</p>

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