Role of Risk Assessments in Viral Safety: An FDA Perspective

Xu, Lixin; Lee, Sang Bong; Fuchs, Chana; Hyams, Kenneth C.; Brorson, Kurt; Swann, Patrick G.

doi:10.5731/pdajpst.2014.00959

Cited by 3 publications

(3 citation statements)

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“…Plasmonic NPs resonant in the NIR made it possible to operate in a wavelength range with minimal collateral damage to coincubated antibodies, which proves the intrinsic value of the technique to selectively inactivate pathogens while retaining the activity of biologics. Biologics are among the fastest growing classes of therapeutic agents in Public Health. , As for all pharmaceuticals derived from cultured cells, microbial contamination is an integral risk of biologics production. , Despite different upstream clearance steps for starting materials, filtration is currently the only technology that can retain potential microbial contaminations without harming the product in monoclonal antibody fabrication. Removal especially of virus and mycoplasma pathogens through passive filtration faces a series of scientific and technical challenges and remains a crucial step in the manufacture of biologics.…”

Section: Discussionmentioning

confidence: 99%

“…51,52 As for all pharmaceuticals derived from cultured cells, microbial contamination is an integral risk of biologics production. 53,54 Despite different upstream clearance steps for starting materials, filtration is currently the only technology that can retain potential microbial contaminations without harming the product in monoclonal fabrication. Removal especially of virus and mycoplasma pathogens through passive filtration faces a series of scientific and technical challenges and remains a crucial step in the manufacture of biologics.…”

Section: ■ Conclusionmentioning

confidence: 99%

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Plasmon-Enhanced Pan-Microbial Pathogen Inactivation in the Cavitation Regime: Selectivity Without Targeting

Nazari¹,

Xi²,

Aronson³

et al. 2019

ACS Appl. Nano Mater.

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Pan-microbial inactivation technologies that do not require high temperatures, reactive chemical compounds, or UV radiation could address gaps in current infection control strategies and provide efficient sterilization of biologics in the biotechnological industry. Here, we demonstrate that femtosecond (fs) laser irradiation of resonant gold nanoparticles (NPs) under conditions that allow for E-field mediated cavitation and shockwave generation achieve an efficient plasmon-enhanced photonic microbial pathogen inactivation. We demonstrate that this NP-enhanced, physical inactivation approach is effective against a diverse group of pathogens, including both enveloped and nonenveloped viruses, and a variety of bacteria and mycoplasma. Photonic inactivation is wavelengthdependent and in the absence of plasmonic enhancement from NPs, negligible levels of microbial inactivation are observed in the near-infrared (NIR) at 800 nm. This changes upon addition of resonant plasmonic NPs, which provide a strong enhancement of inactivation of viral and bacterial contaminants. Importantly, the plasmon-enhanced 800 nm femtosecond (fs)pulse induced inactivation was selective to pathogens and was obtained without specific targeting of the NPs to the pathogens. No measurable damage was observed for antibodies included as representative biologics under identical conditions.

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Section: Discussionmentioning

confidence: 99%

Section: ■ Conclusionmentioning

confidence: 99%

Plasmon-Enhanced Pan-Microbial Pathogen Inactivation in the Cavitation Regime: Selectivity Without Targeting

Nazari¹,

Xi²,

Aronson³

et al. 2019

ACS Appl. Nano Mater.

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“…As iPSCs begin to move into industrial cell manufacturing for clinical use, a need for inexpensive, nonxenogeneic, GMP‐compatible surface coating reagents that are abundantly available arises. Cross‐species culture reagents can elicit an immune response and increase the amount of testing required for release of therapeutic products to identify adventitious viruses (Q5A Viral Safety Evaluation) . In efforts to evolve from laminin rich mouse ECM (Matrigel and Geltrex), most groups have focused on human laminin and vitronectin.…”

Section: Discussionmentioning

confidence: 99%

Human Fibrinogen for Maintenance and Differentiation of Induced Pluripotent Stem Cells in Two Dimensions and Three Dimensions

Gandhi

Knudsen

Hill

et al. 2019

Stem Cells Translational Medicine

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Human fibrin hydrogels are a popular choice for use as a biomaterial within tissue engineered constructs because they are biocompatible, nonxenogenic, autologous use compatible, and biodegradable. We have recently demonstrated the ability to culture induced pluripotent stem cell (iPSC)‐derived retinal pigment epithelium on fibrin hydrogels. However, iPSCs themselves have relatively few substrate options (e.g., laminin) for expansion in adherent cell culture for use in cell therapy. To address this, we investigated the potential of culturing iPSCs on fibrin hydrogels for three‐dimensional applications and further examined the use of fibrinogen, the soluble precursor protein, as a coating substrate for traditional adherent cell culture. iPSCs successfully adhered to and proliferated on fibrin hydrogels. The two‐dimensional culture with fibrinogen allows for immediate adaption of culture models to a nonxenogeneic model. Similarly, multiple commercially available iPSC lines adhered to and proliferated on fibrinogen coated surfaces. iPSCs cultured on fibrinogen expressed similar levels of the pluripotent stem cell markers SSea4 (98.7% ± 1.8%), Oct3/4 (97.3% ± 3.8%), TRA1‐60 (92.2% ± 5.3%), and NANOG (96.0% ± 3.9%) compared with iPSCs on Geltrex. Using a trilineage differentiation assay, we found no difference in the ability of iPSCs grown on fibrinogen or Geltrex to differentiate to endoderm, mesoderm, or ectoderm. Finally, we demonstrated the ability to differentiate iPSCs to endothelial cells using only fibrinogen coated plates. On the basis of these data, we conclude that human fibrinogen provides a readily available and inexpensive alternative to laminin‐based products for the growth, expansion, and differentiation of iPSCs for use in research and clinical cell therapy applications. stem cells translational medicine 2019;8:512–521

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

Roush

2018

Current Opinion in Biotechnology

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Role of Risk Assessments in Viral Safety: An FDA Perspective

Cited by 3 publications

References 1 publication

Plasmon-Enhanced Pan-Microbial Pathogen Inactivation in the Cavitation Regime: Selectivity Without Targeting

Plasmon-Enhanced Pan-Microbial Pathogen Inactivation in the Cavitation Regime: Selectivity Without Targeting

Human Fibrinogen for Maintenance and Differentiation of Induced Pluripotent Stem Cells in Two Dimensions and Three Dimensions

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

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