A 90-day safety study in Sprague-Dawley rats fed milk powder containing recombinant human lactoferrin (rhLF) derived from transgenic cloned cattle

References

• Appel, M. J., Veen, H. A., et al. (2006). Sub-chronic (13-week) oral toxicity study in rats with recombinant human lactoferrin produced in the milk of transgenic cows. Food Chem Toxicol 44:964–973.
   PubMed Web of Science ®Google Scholar
• Barlow, S., Chesson, A., et al. (2008). Food safety, animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer (SCNT) and their offspring and products obtained from those animals. EFSA J 767:1–49.
   Google Scholar
• Baveye, S., Elass, E., Mazurier, J., et al. (1999). Lactoferrin: a multifunctional glycoprotein involved in the modulation of the inflammatory process. Clin Chem Lab Med 37:281–286.
   PubMed Web of Science ®Google Scholar
• Cao, Y., Gao, H. Y., et al. (2002). Research of human lactoferrin gene cloning and expression in cell [in Chinese]. J Hered 24:9–14.
   Google Scholar
• Chen, H. L., Lai, Y. W., et al. (2010). Probiotic Lactobacillus casei expressing human lactoferrin elevates antibacterial activity in the gastrointestinal tract. Biometals 2:11.
   Google Scholar
• Chinese standard GB/T 10765. (1997). Infant formula milk powder one. Beijing, China: Standards Press of China.
   Google Scholar
• Chinese standard NY/T 1102. (2006). Transgenic plants and their products food safety testing—90-day feeding study in rats. Beijing, China: Standards Press of China.
   Google Scholar
• Chong, D. K., Langridge, W. H. (2000). Expression of full-length bioactive antimicrobial human lactoferrin in potato plants. Transgenic Res 9:71–78.
   PubMed Web of Science ®Google Scholar
• Codex (Codex Alimentarius Commission). (2008). Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals. CAC/GL 68–2008. In: Foods derived from modern biotechnology, 2nd ed. Rome, Italy: World Health Organization, Food and Agriculture Organization of the United Nations. Rome, Italy.
   Google Scholar
• Davidson, L. A., Lönnerdal, B. (1988). Specific binding of lactoferrin to brush-border membrane: ontogeny and effect of glycan chain. Am Physiol Soc 254(Pt 4):G580–G585.
   PubMed Web of Science ®Google Scholar
• Davidson, L. A., Litov, R. E., Lönnerdal, B. (1990). Iron retention from lactoferrin-supplemented formulas in infant Rhesus monkeys. Pediatr Res 27:176–180.
   PubMed Web of Science ®Google Scholar
• Foley, A. A., Bates, G. W. (1987). The purification of lactoferrin from human whey by batch extraction. Anal Biochem 162:296–300.
   PubMed Web of Science ®Google Scholar
• Heyman, Y., Chavatte-Palmer, P., et al. (2007). Assessing the quality of products from cloned cattle: an integrative approach. Theriogenology 67:134–141.
   PubMed Web of Science ®Google Scholar
• Hiroyuki, T., Kazunori, S., et al. (2000). Milk and dairy products in cancer prevention: focus on bovine lactoferrin. Mutat Res 462:227–233.
   PubMed Web of Science ®Google Scholar
• Jones, D. D. (1998). Advisory considerations on the scientific basis of the food safety evaluation of transgenic animals. In: Holland, A., Johnson, A. (Eds.), Animal biotechnology and ethics ( pp 265–275). London: Chapman & Hall.
   Google Scholar
• Kleter, G. A., Kuiper, H. A. (2002). Considerations for the assessment of the safety of genetically modified animals used for human food or animal feed. Livest Prod Sci 74:275–285.
   Google Scholar
• Legrand, D., Elass, E., Pierce, A., et al. (2004). Lactoferrin and host defence: an overview of its immuno-modulating and anti-inflammatory properties. Biometals 17:225–229.
   PubMed Web of Science ®Google Scholar
• Lema, M.A., Burachik, M. (2009). Safety assessment of food products from r-DNA animals. Comp Immunol Microbiol Infect Dis 32:163–189.
   PubMed Web of Science ®Google Scholar
• Li, S. Q., Zhang, L. Q., et al. (2002). Fusion expression of human lactoferrin protein in a prokaryotic cell [in Chinese]. China Dairy Industry 30:3–5.
   Google Scholar
• Liang, Q. W., Richardson, T. (1993). Expression and characterization of human lactoferrin in yeast Saccharomyces cerevisiae. Agric Food Chem 41:1800–1807.
   Web of Science ®Google Scholar
• Ling, X. P., Pang, G. C., et al. (2003). The latest research advances of lactoferrin [in Chinese]. Food Sci 24:160–163.
   Google Scholar
• Lönnerdal, B., Bryantthe, A. (2006). Absorption of iron from recombinant human lactoferrin in young US women. Clin Nutr 83:305–309.
   Web of Science ®Google Scholar
• Lönnerdal, B., Iyer, S. (1995). Lactoferrin: molecular structure and biological function. Annu Rev Nutr 15:93–110.
   PubMed Web of Science ®Google Scholar
• Masanori, I., Akito, N., et al. (2000). Characterization of antiviral activity of lactoferrin against hepatitis C virus infection in human cultured cell. Virus Res 66:51–63.
   PubMed Web of Science ®Google Scholar
• Mikogami, T., Marianne, T., Spik, G. (1995). Effect of intracellular iron depletion by picolinic acid on expression of the lactoferrin receptor in the human colon carcinoma cell subclone HT29-18-C1. Biochem J 308:391–397.
   PubMed Web of Science ®Google Scholar
• Naot, D., Grey, A., Reid, I. R., et al. (2005). Lactoferrin—a novel bone growth factor. Clin Med Res 3:93–101.
   PubMedGoogle Scholar
• Nuijens, J. H., Berkel, P. H., Geerts, M. E., et al. (1997). Characterization of recombinant human lactoferrin secreted in milk of transgenic mice. Biol Chem 272:8802–8807.
   Web of Science ®Google Scholar
• Palmano, K. P., Elgar, D. F. (2002). Detection and quantitation of lactoferrin in bovine whey samples by reversed phase high performance liquid chromatography polystyrene-divinylbenzene. Chromatogr A 947:307–311.
   PubMed Web of Science ®Google Scholar
• Platenburg, G. J., Kootwijk, E. P., Kooiman, P. M., et al. (1994). Expression of human lactoferrin in milk of transgenic mice. Transgen Res 3:99–108.
   PubMed Web of Science ®Google Scholar
• Reeves, P. G., Nielsen, F. H., Fahey, J. R., et al. (1993). AIN-93 purified diets for laboratory rodents: final report of the American Institute of Nutrition ad hoc writing committee on the reformulation of the AIN-76A rodent diet. J Nutr 123:1939–1951.
   PubMed Web of Science ®Google Scholar
• Rudenko, L., Matheson, J. C., Adams, A. L., et al. (2004). Food consumption risks associated with animal clones: what should be investigated? Cloning Stem Cells 6:79–93.
   PubMedGoogle Scholar
• Spik, G., Strecker, G., Fournet, B., Bouquelet, S., Montreuil, J. (1988). Comparative study of the primary structure of glycans from human lactotransferrin. Eur J Biochem 121:413–419.
   Google Scholar
• Stowell, K. M., Rodo, T. A., Funk, W. D., et al. (1991). Expression of cloned human lactoferrin in baby-hamster kidney cells. Biochem J 276:349–355.
   PubMed Web of Science ®Google Scholar
• Takahashi, S., Ito, Y. (2004). Evaluation of meat products from cloned cattle: biological and biochemical properties. Cloning Stem Cells 6:165–171.
   PubMedGoogle Scholar
• Tomé, D., Dubarry, M., Fromentin, G. (2004). Nutritional value of milk and meat products derived from cloning. Cloning Stem Cells 6:172–177.
   PubMedGoogle Scholar
• U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine. (2008). Guidance for industry use of animal clones and clone progeny for human food and animal feed. Silver Spring, Maryland, USA: U.S. Food and Drug Administration.
   Google Scholar
• Van, V. H. A., Geerts, M. E. J., van Berkel, P. H. C., et al. (2002). Analytical cation-exchange chromatography to assess the identity, purity, and N-terminal integrity of human lactoferrin. Anal Biochem 309:60–66.
   PubMed Web of Science ®Google Scholar
• Vorland, L. H. (1999). Lactoferrin: a multifunctional glycoprotein. APMIS 107:971–981.
   PubMed Web of Science ®Google Scholar
• Wakabayashi, H., Takakura, N., Yamauchi, K., et al. (2002). Effect of lactoferrin feeding on the host antifungal response in guinea-pigs infected or immunised with Trichophyton mentagrophytes. Med Microbiol 51:844–850.
   PubMed Web of Science ®Google Scholar
• Ward, P. P., Paz, E., Conneely, O. M. (2005). Multifunctional roles of lactoferrin: a critical overview. Cell Mol Life Sci 62:2540–2548.
   PubMed Web of Science ®Google Scholar
• Wu, S. C., Chen, H. L., Yen, C. C., et al. (2007). Recombinant porcine lactoferrin expressed in the milk of transgenic mice enhances offspring growth performance. Agric Food Chem 55:4670–4677.
   PubMed Web of Science ®Google Scholar
• Yamaguchi, M., Ito, Y., et al. (2007). Fourteen-week feeding test of meat and milk derived from cloned cattle in the rat. Theriogenology 67:152–165.
   PubMed Web of Science ®Google Scholar
• Yamaguchi, M., Ito, Y., et al. (2008). A 12-month feeding study of reproduction/development in rats fed meat/milk powder supplemented diets derived from the progeny of cloned cattle produced by somatic cell nuclear transfer. J Reprod Dev 54:321–334.
   PubMed Web of Science ®Google Scholar
• Yang, P., Wang, J., Gong, G., Sun, X., Zhang, R., Du, Z., et al. (2008). Cattle mammary bioreactor generated by a novel procedure of transgenic cloning for large-scale production of functional human lactoferrin. PLoS One 3:1–9.
   Google Scholar
• Zimecki, M., Artym, J., Chodaczek, G., et al. (2004). Protective effects of lactoferrin in Escherichia coli–induced bacteremia in mice: relationship to reduced serum TNF alpha level and increased turnover of neutrophils. Inflam Res 53:292–296.
   PubMed Web of Science ®Google Scholar