Preliminary safety assessment of Yarrowia lipolytica extracellular lipase: Results of acute and 28-day repeated dose oral toxicity studies in rats

Turki, Saoussen; Jabloun, Zeineb; Mrabet, Ghada; Marouani, Ammar; Thonart, Philippe; Diouani, Mohamed Fethi; Abdallah, Fethi Ben; Amara, Abdelkader; Rejeb, Ahmed; Kallel, Héla

doi:10.1016/j.fct.2010.05.077

Cited by 17 publications

(7 citation statements)

References 13 publications

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“…Its safety was preliminarily tested in acute and 28-day repeated dose oral toxicity studies in rats (Turki et al, 2010a). The results demonstrated that there were no toxicologically severe changes in clinical signs, growth, hematology, clinical chemistry, organ weights and pathology related to oral administration of extracellular Y. lipolytica lipase in rats.…”

Section: Safety Studies On Yarrowia and Yarrowia-derived Productsmentioning

confidence: 96%

Yarrowia lipolytica: Safety assessment of an oleaginous yeast with a great industrial potential

Groenewald

Boekhout

Neuvéglise

et al. 2013

Critical Reviews in Microbiology

372

278

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Yarrowia lipolytica has been developed as a production host for a large variety of biotechnological applications. Efficacy and safety studies have demonstrated the safe use of Yarrowia-derived products containing significant proportions of Yarrowia biomass (as for DuPont's eicosapentaenoic acid-rich oil) or with the yeast itself as the final product (as for British Petroleum's single-cell protein product). The natural occurrence of the species in food, particularly cheese, other dairy products and meat, is a further argument supporting its safety. The species causes rare opportunistic infections in severely immunocompromised or otherwise seriously ill people with other underlying diseases or conditions. The infections can be treated effectively by the use of regular antifungal drugs, and in some cases even disappeared spontaneously. Based on our assessment, we conclude that Y. lipolytica is a ''safe-to-use'' organism.

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Section: Safety Studies On Yarrowia and Yarrowia-derived Productsmentioning

confidence: 96%

Yarrowia lipolytica: Safety assessment of an oleaginous yeast with a great industrial potential

Groenewald

Boekhout

Neuvéglise

et al. 2013

Critical Reviews in Microbiology

372

278

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“…For example, Guieysse et al (2004) showed that the lipase Lip2p can be used as a selective catalyst to resolve a racemic mixture of 2-bromo-aryl acetic acid esters. Based on safety data, it was also revealed that the extracellular lipase Lip2p from Y. lipolytica can be used as a pharmaceutical (Turki et al, 2010b). Turki et al (2010c) reported that the lipase Lip2p can be used as a therapeutic tool for exocrine pancreatic insufficiency treatment.…”

Section: Secretion Of Proteinsmentioning

confidence: 97%

Biotechnological applications of Yarrowia lipolytica: Past, present and future

Liu

Huang

2015

Biotechnology Advances

197

112

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“…In a previous study, we developed an efficient process for the production and purification of the extracellular lipase in Y. lipolytica bioreactor culture [15]. The safety of oral administration of Y. lipolytica lipase was also assessed in vivo by conducting toxicity studies in rats [16]. Herein, we carried out for the first time, in vitro studies to evaluate the stability of three powder formulations of lipase sourced from Y. lipolytica in conditions mimicking the human GI (gastrointestinal) tract.…”

Section: Introductionmentioning

confidence: 99%

A highly stable Yarrowia lipolytica lipase formulation for the treatment of pancreatic exocrine insufficiency

Turki

Mrabet

Jabloun

et al. 2010

Biotech and App Biochem

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Yarrowia lipolytica lipase has been assumed to be a good candidate for the treatment of fat malabsorption in patients with pancreatic insufficiency. Nevertheless, no systematic studies on its stability under physiological conditions pertaining to the human GI (gastrointestinal) tract have been published. Stability of various Y. lipolytica lipase powder formulations at various physiological pH values as well as the effect of digestive proteases and bile salts on enzyme activity were investigated. Results were compared with those obtained from another competing fungal lipase sourced from Candida rugosa. Among the studied formulations, Y. lipolytica lipase stabilized with gum arabic and skimmed milk powder was the most promising powder formulation. Under acidic conditions (pH 3-5), this formulation showed higher stability than those observed with the other Y. lipolytica lipase formulations and C. rugosa lipase. In addition, in the presence of gum arabic and skimmed milk powder as additives, Y. lipolytica lipase exhibited markedly higher resistance to pepsin, trypsin and chymotrypsin actions. Resistance to proteolytic degradation by digestive proteases was also by far higher than that observed with C. rugosa lipase. Similar behaviour was, however, observed when these two fungal lipases were incubated with increased concentrations of bile salts. Residual lipase activity of both fungal lipases showed a slight decrease in NaTDC (sodium taurodeoxycholate) concentration above 4 mM. Consequently, Y. lipolytica lipase formulated with gum arabic and milk powder seemed to have great potential for use as a therapeutic tool for patients with pancreatic insufficiency.

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Preliminary safety assessment of Yarrowia lipolytica extracellular lipase: Results of acute and 28-day repeated dose oral toxicity studies in rats

Cited by 17 publications

References 13 publications

Yarrowia lipolytica: Safety assessment of an oleaginous yeast with a great industrial potential

Yarrowia lipolytica: Safety assessment of an oleaginous yeast with a great industrial potential

Biotechnological applications of Yarrowia lipolytica: Past, present and future

A highly stable Yarrowia lipolytica lipase formulation for the treatment of pancreatic exocrine insufficiency

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