Assignment: SWOT Analysis in the life science

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For this assignment, you will read primary article B which is based on a specific area of biotechnology. You will also read a few resources that will help you think creatively and innovatively before you complete the SWOT analysis. You will then analyze and critique the article for its innovative potential in one of four areas:

1) development of a new research method

2) development of a new research project

3) development of a new product

4) development of a new service

Food and Chemical Toxicology 100 (2017) 34e41 Contents lists available at ScienceDirect Food and Chemical Toxicology journal homepage: Safety assessment of genetically modified milk containing human beta-defensin-3 on rats by a 90-day feeding study Xin Chen a, 1, Ming-Qing Gao a, b, 1, Dong Liang a, Songna Yin a, c, Kezhen Yao a, Yong Zhang a, b, * a b c College of Veterinary Medicine, Northwest A&F University, Yangling 712100, Shaanxi, China Key Laboratory of Animal Biotechnology, Ministry of Agriculture, Northwest A&F University, Yangling 712100, Shaanxi, China Medical College, Yan'an University, Yan'an 716000, Shaanxi, China a r t i c l e i n f o a b s t r a c t Article history: Received 7 September 2016 Received in revised form 8 December 2016 Accepted 10 December 2016 Available online 12 December 2016 In recent years, transgenic technology has been widely applied in many fields. There is concern about the safety of genetically modified (GM) products with the increased prevalence of GM products. In order to prevent mastitis in dairy cows, our group produced transgenic cattle expressing human beta-defensin-3 (HBD3) in their mammary glands, which confers resistance to the bacteria that cause mastitis. The milk derived from these transgenic cattle thus contained HBD3. The objective of the present study was to analyze the nutritional composition of HBD3 milk and conduct a 90-day feeding study on rats. Rats were divided into 5 groups which consumed either an AIN93G diet (growth purified diet for rodents recommended by the American Institute of Nutrition) with the addition of 10% or 30% HBD3 milk, an AIN93G diet with the addition of 10% or 30% conventional milk, or an AIN93G diet alone. The results showed that there was no difference in the nutritional composition of HBD3 and conventional milk. Furthermore, body weight, food consumption, blood biochemistry, relative organ weight, and histopathology were normal in those rats that consumed diets containing HBD3. No adverse effects were observed between groups that could be attributed to varying diets or gender. © 2016 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license ( Keywords: Genetically modified milk HBD3 Safety assessment 90-Day feeding study Abbreviations: AIN93G diet Growth purified diet for rodents recommended by the American Institute of Nutrition ALB albumin ALP alkaline phosphatase ALT alanine aminotransferase AST aspartate aminotransferase BUN urea nitrogen CAC Codex Alimentarius Commission FAO Food and Agriculture Organization GLO globulin GM genetically modified HBD3 human beta-defensin-3 HE hematoxylin-eosin * Corresponding author. College of Veterinary Medicine, Northwest A&F University, Taicheng Road 3, Yangling 712100, China. E-mail address: (Y. Zhang). 1 The co-author have the equal contribution. 0278-6915/© 2016 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license ( X. Chen et al. / Food and Chemical Toxicology 100 (2017) 34e41 35 OECD Organization for Economic Co-operation and Development TBIL total bilirubin T-CHOL total cholesterol TG triglyceride TP total protein WHO World Health Organization w/w (weight/weight) 1. Introduction Human beta-defensin-3 (HBD3) is a small, cationic, host defense peptide comprised of 45 amino acid residues, which was first isolated from human lesional psoriatic scales and cloned from keratinocytes by Harder et al. (2001). HBD3 possesses six conserved cysteine residues that facilitate both broad antimicrobial activity against many pathogenic microbes and diverse innate immune functions (Van Hemert et al., 2012). Previous studies have shown that HBD3 is effective against the majority of Gram-positive and Gram-negative bacteria, including a number of multiple antibiotic resistant strains (Maisetta et al., 2006; Zasloff, 2002). The antimicrobial effects of HBD3 differ for different strains of bacteria. In an in vitro study of oral cavity bacteria, aerobes were found to be more sensitive to HBD3 than anaerobes (Joly et al., 2004). HBD3 also has inhibitory effects against fungi and viruses (Dhople et al., 2006). Quinones-Mateu et al. (2003) reported that HBD3 can inhibit replication of the human immunodeficiency virus. In addition, HBD3 has chemotaxis effects on immature dendritic cells and memory T cells (Scudiero et al., 2010). Therefore, HBD3 plays an important role in the regulation of immunity. In the immune system, HBD3 acts as a bridge linking innate immunity and acquired immunity. Mastitis is the most common disease related to milk production in dairy cows. Mastitis causes great economic losses due to a decrease in the quality and quantity of milk production and the increased cost of disease treatment (Kerro Dego et al., 2002; Sinha et al., 2014). Mastitis is an inflammatory response to pathogenic microorganisms entering through the teat canal and multiplying in the mammary gland (Oviedo-Boyso et al., 2007). Many different bacteria can cause mastitis, including contagious and environmental bacteria such as Staphylococcus aureus, Escherichia coli, and Streptococcus dysgalactiae. Antibiotics are the most common treatment for mastitis. However, antibiotics are not an ideal treatment as there are various different pathogenic bacteria species that could cause infection and the overuse of antibiotics also causes problems such as drug-resistant bacterial strains and milk containing antibiotic residues which is unfit for consumption. Transgenic animals are animals where one or more genes from one organism has been transferred to another by using genetic engineering technologies (Hino, 2002). With the continued development of transgenic technology, genetically modified (GM) products are becoming more prevalent in daily life. When new GM products are developed, testing must be performed to determine whether the new trait will affect the nutritional value of the product or consumer health. The safety assessment of GM products focuses primarily on potential allergenic compounds in the food, the nutritional content of the food, possible expression of antibiotic selection markers, and transgene stability and inheritance (Domingo, 2016; Domingo and Gine Bordonaba, 2011; Nicolia et al., 2014). The current principles of the safety assessment for GM products, which are accepted by most nations and organizations, support the concept of substantial equivalence and the steps involved for the scientific evaluation of each GM product are formed in a case by case basis (Codex, 2008; OECD, 1993). Feeding studies are often used to assess the safety of food products, including GM products. Traditionally, a feeding study is conducted within 30 days or 90 days for a general health assessment. If the GM product is for a special population such as infants or the elderly, special parameters in addition to general health may need to be evaluated, and thus a feeding study may be conducted using animals of different ages over varying lengths of time (Malatesta et al., 2008). Many GM products have been the subject of feeding studies, including rice (Schroder et al., 2007; Tang et al., 2012; Yuan et al., 2013), soybeans (Appenzeller et al., 2008), tomatoes (Fares and El-Sayed, 1998), maize grain (He et al., 2008, 2009), and animal products such as meat and milk (S. Liu et al., 2013; Yamaguchi et al., 2007; Zhou et al., 2011). In order to prevent mastitis in dairy cows, our group exploited the broad-spectrum antimicrobial activity of HBD3 and produced transgenic cattle expressing HBD3 specifically in their mammary glands to prevent colonization in this area by the bacteria that cause mastitis. Lactation in the transgenic cattle was comparable to healthy conventional cattle, and the milk from transgenic cows repressed the growth of both S. aureus and E. coli. (Yu et al., 2013). A previous in vitro study showed the GM milk containing HBD3 was easy to digest, and did not cause any adverse effects on the general and gastrointestinal health of the mice in the study (Chen et al., 2016). Rat and mouse models are the commonly-used model animals in feeding studies. Here, we analyzed the composition of HBD3 GM milk and the general health of rats following consumption of HBD3 GM milk, which included analysis of body weight, food consumption, blood biochemistry, relative organ weight, and pathology. A 90-day feeding study was conducted in accordance with the Chinese Toxicology Assessment Procedures and Methods for Food Safety (Chinese standard GB 15193.13e2003). 2. Materials and methods 2.1. Test sample The GM milk containing HBD3 was produced by transgenic cattle with HBD3 inserted into a “safe harbor” in the bovine genome by phiC31 integrase. The concentration of HBD3 in the milk was measured during the lactation period using ELISA, and it ranged from 3.9 to 10.4 mg/ml (Yu et al., 2013). We selected the milk with the highest HBD3 concentration for use in this study. 36 X. Chen et al. / Food and Chemical Toxicology 100 (2017) 34e41 The conventional milk was acquired from Yangling Keyuan Cloning Co., Ltd., China. 2.2. Nutritional composition analysis of milk Analyses of protein, fat, lactose, and solids of GM and non-GM milk were performed in accordance with standard methods (Chinese Standard GB 5009.5e2010, GB 5413.3e2010, GB 5413.5e2010, and GB 5413.39e2010, respectively). Amino acid, mineral, and vitamin composition of GM and non-GM milk were also measured in accordance with standard methods (Chinese Standard GB/T 5009.124e2003, GB 5413.21e2010, and GB 5413.9e2010, respectively). 2.3. Experimental animals and diets Sixty male and 60 female pathogen-free Sprague Dawley rats were obtained from the Laboratory Animal Center of the Fourth Military Medical University (Xi'an, Shaanxi, China). All rats were four weeks old at the start of treatment and were housed in a polypropylene plastic cage with ad libitum access to water and food. Room temperature was maintained 22  C ± 2  C, with a 50% ± 10% relative humidity, five air changes per hour, and a 12-h light/dark cycle. Rats were acclimatized for five days and fed with the AIN93G diet (growth purified diet for rodents recommended by the American Institute of Nutrition) before they were randomly divided into five groups with 12 rats/sex/group. Experimental groups were fed diets supplemented with 10% or 30% (w/w) GM milk according to the AIN93G diet, and control groups were fed diets supplemented with the corresponding concentration of conventional milk. A further group that served as the negative control was fed with only the AIN93G diet. In order to simplify the reference to each group, those animals fed the AIN93G diet alone, the AIN93G diet with the addition of 10% HBD3 milk, the AIN93G diet with the addition of 30% HBD3 milk, the AIN93G diet with the addition of 10% conventional milk, and the AIN93G diet with the addition of 30% conventional milk were designated as the C, 10G, 30G, 10N, and 30N group, respectively. To meet the nutritional requirements of the AIN93G diet, the composition of animal feed was 24% soybean meal, 30% flour, 5% fish meal, 20% corn, 12% bran, 2% grass meal, 2% yeast power, 1.5% vegetable oil, 1.3% mountain flour, 1.6% Calcium hydrogen phosphate, and 0.6% salt. The 30G diet, 10G diet, 30N diet and 10N diet were the AIN93G diet with the addition of the corresponding concentrations of milk. All feed ingredients were combined and thoroughly mixed to ensure homogeneity. The dough was cut into appropriately sized pellets and oven-dried. During pellet production, drying temperatures were set to 55  C in order to maintain protein activity. All diets were divided into aliquots sufficient for a single-day feeding and vacuum-packed to prevent potential decomposition of the fodder due to long-term air exposure. The bioactivity of HBD3 in pellet was examined by analyzing its resistant capacity to Staphylococcus aureus (Fig. S1). The methodology of the study was approved by the Animal Care Commission of the College of Veterinary Medicine, Northwest A&F University. Each animal received humane care. The study was performed in accordance with the institution's guidelines. 2.4. Clinical observations, body weight, and food consumption During the feeding trial, rats were monitored daily for mortality and signs of morbidity or clinical signs of toxicity. We also observed their appearance (piloerection, kyphosis, disheveled fur, and secreta), their behavior (altered grooming or nesting), and activity (altered exploring) each day. Body weight and food consumption of each rat were recorded weekly. 2.5. Organ weight, gross necropsy, and pathology At the end of the feeding study, rats were anesthetized and killed by cervical dislocation. A thorough necropsy of major organs was performed and the heart, liver, spleen, lungs, and kidneys (paired) were excised, examined, and weighed. Tissue samples were fixed in 4% buffered formaldehyde for more than 24 h before histological processing, then embedded in paraffin in order to create 4e6-mm thick sections which were stained with hematoxylin-eosin (HE) for light microscopy (OLYMPUS, BX-50, Tokyo, Japan). For histopathological analysis, we observed the pericardium and myocardial fibers of the heart; the capsule, hepatic artery, and hepatic vein of the liver; the capsule, red pulp, and white pulp of the spleen; the pleurae, alveoli, alveolar space, bronchia, and blood vessels of the lungs; and the capsule, renal cortex and medulla, glomerulus, and renal tubular of the kidneys. 2.6. Blood biochemistry Before collecting blood samples, rats were subject to fasting overnight with water provided ad libitum. The rats were anesthetized and blood samples were collected from the orbital sinus vein. The serum chemistry parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total protein (TP), albumin (ALB), globulin (GLO), total bilirubin (TBIL), urea nitrogen (BUN), total cholesterol (T-CHOL), and triglyceride (TG) were measured with an auto-analyzer (Hitachi 7180, Tokyo, Japan). 2.7. Statistical analysis Statistical comparisons were designed to determine whether significant differences between values were attributable to the consumption of HBD3. Data obtained from groups fed the 10G and 30G diets were first compared with data from the group fed the 10N and 30N diets, respectively, and then compared with that from the group fed the AIN93G diet. All data were analyzed using SPSS 20.0 statistical software (IBM Corporation, Somers, NY, USA). Data were tested by one-way ANOVA and least-significant difference tests. Data is presented as the mean ± SD, with p < 0.05 considered as significantly different. 3. Results 3.1. Milk nutritional composition analysis The nutritional compositions of the GM and conventional milk used in the feeding trial were subjected to comprehensive analysis. The results showed that the gross composition of GM and conventional milk was not statistically different (Table 1). All values were within the normal range according to the Chinese Standard. Amino acid, mineral, and vitamin composition of GM milk were also not significantly different when compared with those of conventional milk (Table 2, Table 3, and Table 4, respectively). These results also conformed to the requirements of the Chinese national food safety standard. Table 1 Gross composition of non-GM and GM milk (Mean ± SD, n ¼ 3). Non-GM milk Fat (g/100 g) Protein (g/100 g) Lactose (g/100 g) pH Solids (g/100 g) 3.57 2.99 4.87 6.69 8.13 ± ± ± ± ± 0.25 0.18 0.04 0.02 0.05 GM milk 3.44 3.24 4.83 6.73 8.27 ± ± ± ± ± 0.21 0.13 0.11 0.02 0.11 X. Chen et al. / Food and Chemical Toxicology 100 (2017) 34e41 Table 2 Amino acid composition of non-GM and GM milk (Mean ± SD, n ¼ 3). Amino acid (mg/g) Non-GM milk Asp Thr Ser Glu Pro Gly Ala Cys Val Met Lle Leu Tyr Phe Lys His Arg 1.70 0.93 1.20 3.67 4.33 0.43 0.73 0.00 1.33 0.40 1.07 2.23 1.13 1.17 1.63 1.13 0.83 ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± GM milk 0.10 0.06 0.10 1.80 0.25 0.06 0.06 0.00 0.06 0.10 0.06 0.21 0.06 0.15 0.12 0.06 0.06 1.73 0.87 1.20 4.73 4.47 0.47 0.80 0.00 1.37 0.43 1.03 2.33 1.17 1.20 1.70 1.13 0.77 ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± 0.06 0.06 0.10 0.21 0.23 0.06 0.10 0.00 0.06 0.12 0.06 0.15 0.06 0.17 0.10 0.06 0.06 Table 3 Mineral composition of non-GM and GM milk (Mean ± SD, n ¼ 3). Ca (mg/kg) Mg (mg/kg) P (mg/kg) K (mg/kg) Na (mg/kg) Fe (mg/kg) Zn (mg/kg) Se (mg/kg) Non-GM milk GM milk 750.19 ± 32.26 127.24 ± 3.80 1896.14 ± 15.14 2601.17 ± 53.11 490.51 ± 79.25 4.33 ± 0.71 14.58 ± 0.37 0.02 ± 0.00 807.55 ± 139.10 127.20 ± 5.07 1895.63 ± 31.62 2609.21 ± 51.53 490.25 ± 77.25 4.46 ± 1.05 14.51 ± 0.42 0.02 ± 0.00 Table 4 Vitamin composition of non-GM and GM milk (Mean ± SD, n ¼ 3). Vitamin Non-GM milk A(mg/100 g) E(mg/100 g) B1 (mg/100 g) B2 (mg/100 g) 0.03 0.07 0.07 0.35 ± ± ± ± 0.01 0.02 0.01 0.01 GM milk 0.03 0.07 0.07 0.47 ± ± ± ± 0.02 0.01 0.01 0.14 3.2. Clinical signs, body weights, and food consumption Over the course of the feeding trial, we observed the rats for clinical signs of toxicity or morbidity each day. The body weight and food consumption of each rat were measured weekly. All rats survived the duration of the feeding trial. No clinical signs of toxicity were observed in any of the groups. The appearance, behavior, and activity of all rats were normal. There were no significant differences in body weight or food consumption between rats fed different diets. Body weight in 30G and 30N groups were slightly higher than that in other groups in male and female rats (Fig. 1). According to the mean daily food consumption, we calculated the total consumption of HBD3. The total consumption of HBD3 of 30G and 10G groups in male rats were approximately 5876.405 mg and 1883.735 mg, respectively. The total consumption of HBD3 of 30G and 10G groups in female rats were approximately 4393.494 mg and 1462.374 mg, respectively (Table S1). 3.3. Blood biochemistry The blood biochemistry results are shown in Table 5 and Table 6. There were no significant differences in the majority of the measured parameters. The levels of TG and TBIL of males in the 30G group were slightly lower than those in the C group. However, there 37 was no difference between 30G and 30N groups regarding TG and TBIL levels. In female rats, ALT in 30G and 10N groups were lower than that in the C group, and ALT in the 10N group was significant lower than that in the 10G group. Although there were several differences observed concerning blood biochemistry results, all the parameters were within the normal range. 3.4. Gross necropsy and relative organ weight A complete necropsy was conducted on all rats. No treatmentrelated adverse gross lesions were observed during the entire necropsy process. No statistical difference was observed in relative organ weight between experimental treatment groups and the control group (Table 7). 3.5. Histopathology Following histopathological observation, sporadic microscopic changes were found in all groups. No severe histopathological lesions were observed in any organ tissue sections (Fig. 2). For the heart, the pericardium was intact without exudate. No degeneration, necrosis, atrophy, hypertrophy, or inflammatory cell infiltration in myocardial fibers was observed. No obvious differences in the heart were observed between each group. For the liver, the capsule of the liver was intact in each group. There was no obvious connective tissue hyperplasia. The central hepatic vein, the small branches of hepatic artery and the hepatic vein were normal in each group. For the spleen, the capsule of the spleen of each group was complete. The structure of red pulp and white pulp were clear. There was no significant difference in each group. For the lungs, the pleurae of the lung were smooth without exudate in all groups. No collapsed alveoli or bullous alveoli were observed. There was no exudate in the alveolar space. The structure of the bronchia and blood vessels of the lung appeared normal. For the kidneys, the capsule of the kidney was intact with a clear cortico-medullary junction in each group. Glomerular and renal tubular epithelial cell size were within the normal range in each group. 4. Discussion Since the development of advanced genetic technologies, it is possible to transfer a gene from one organism to another without sexual reproduction. This process allows desirable alterations to be made to animal genomes (Gaj et al., 2013). Transgenic technology is widely used in medicine, agriculture, research, and industry. In animal science, a large number of these GM products are treated as potential food. The concern about the safety of GM products arises with the increased prevalence of GM products. Many international organizations have designed various guidelines to assess the safety of GM products, such as the Food and Agriculture Organization (FAO) of the United Nations, the World Health Organization (WHO), the Organization for Economic Co-operation and Development (OECD), and the Codex Alimentarius Commission (CAC). Regardless of country-of-origin or governing organization, GM products should undergo a strict evaluation before they are allowed to enter the market. A 30- or 90-day feeding study is traditionally used to assess the safety of a GM product. For GM products with varying final purposes, different animals will be used for the feeding studies. For example, cattle and sheep are consistently selected in feeding trials to study the effects of GM products on the composition and yield of milk (Calsamiglia et al., 2007). Once animal models consume GM products, informative data can be generated by analyzing and comparing multiple health related parameters. Mastitis is a highly prevalent disease in dairy industries worldwide and results in great economic losses. Traditional 38 X. Chen et al. / Food and Chemical Toxicology 100 (2017) 34e41 Fig. 1. Body weight and daily food consumption. (A) Mean body weight of male rats (n ¼ 12); (B) Mean body weight of female rats (n ¼ 12); (C) Mean daily food consumption of male rats (n ¼ 12); (D) Mean daily food consumption of female rats (n ¼ 12). The C, 10G, 30G, 10N, and 30N group represented those animals fed the AIN93G diet alone, the AIN93G diet with the addition of 10% HBD3 milk, the AIN93G diet with the addition of 30% HBD3 milk, the AIN93G diet with the addition of 10% conventional milk, and the AIN93G diet with the addition of 30% conventional milk, respectively. Table 5 Blood biochemistry of male rats following 90 days. (Mean values ± SD, n ¼ 12). ALT(U/L) AST(U/L) ALP(U/L) TP(g/L) ALB(g/L) GLO(g/L) TG(mmol/L) TBIL(mmol/L) T-CHOL(mmol/L) BUN(mmol/L) 30G 30N 10G 10N C 41.6 ± 5.3 122.9 ± 24.1 92.8 ± 20.3 53.1 ± 3.3 22.9 ± 1.5 30.2 ± 1.9 1.02 ± 0.31* 0.95 ± 0.11* 1.86 ± 0.24 6.94 ± 0.83 42.4 ± 3.7 131.5 ± 17.8 89.4 ± 21.7 52.9 ± 2.7 23.1 ± 1.9 29.8 ± 2.0 1.13 ± 0.25 1.06 ± 0.21 1.90 ± 0.19 7.12 ± 1.13 40.9 ± 6.2 126.1 ± 22.5 91.9 ± 17.3 53.9 ± 2.5 21.8 ± 1.7 32.1 ± 2.2 1.24 ± 0.19 1.12 ± 0.13 1.79 ± 0.18 7.25 ± 0.92 42.7 ± 5.5 119.5 ± 29.2 88.5 ± 21.2 53.1 ± 3.0 22.0 ± 0.9 31.1 ± 1.7 1.29 ± 0.33 1.09 ± 0.18 1.75 ± 0.33 7.17 ± 0.72 40.9 ± 4.4 124.6 ± 18.6 93.4 ± 27.1 52.1 ± 1.8 22.3 ± 1.4 29.8 ± 2.4 1.32 ± 0.36 1.12 ± 0.15 1.79 ± 0.23 7.59 ± 1.29 ALT: alanine aminotransferase, AST: aspartate aminotransferase, ALP: alkaline phosphatase, TP: total protein, ALB: albumin, GLO: globulin, TG: triglyceride, TBIL: total bilirubin, T-CHOL: total cholesterol, and BUN: urea nitrogen. *p < 0.05 versus C group. The C, 10G, 30G, 10N, and 30N group represented those animals fed the AIN93G diet alone, the AIN93G diet with the addition of 10% HBD3 milk, the AIN93G diet with the addition of 30% HBD3 milk, the AIN93G diet with the addition of 10% conventional milk, and the AIN93G diet with the addition of 30% conventional milk, respectively. treatment of the disease involves the administration of antibiotics. However, this practice promotes the development of antibioticresistant bacteria strains and results in the disposal of milk that contains antibiotics residues. Previous studies showed that transgenic dairy animals that produce anti-bacterial proteins in their milk have less mastitis (J. Liu et al., 2013; Wall et al., 2005; Yang X. Chen et al. / Food and Chemical Toxicology 100 (2017) 34e41 39 Table 6 Blood biochemistry of female rats following 90 days. (Mean values ± SD, n ¼ 12). ALT(U/L) AST(U/L) ALP(U/L) TP(g/L) ALB(g/L) GLB(g/L) TG(mmol/L) TBIL(mmol/L) T-CHOL(mmol/L) BUN(mmol/L) 30G 30N 10G 10N C 32.9 ± 6.4* 109.7 ± 16.8 49.8 ± 7.1 56.2 ± 2.9 30.7 ± 2.1 25.5 ± 2.0 0.69 ± 0.10 0.92 ± 0.09 1.61 ± 0.16 5.62 ± 0.74 35.7 ± 6.6 107.9 ± 21.3 47.0 ± 12.9 56.7 ± 3.5 29.8 ± 2.5 26.9 ± 2.4 0.71 ± 0.15 0.94 ± 0.11 1.59 ± 0.20 5.47 ± 0.82 40.3 ± 4.8 111.7 ± 19.2 50.2 ± 8.6 57.1 ± 3.7 31.3 ± 1.6 25.8 ± 1.9 0.75 ± 0.11 0.89 ± 0.13 1.56 ± 0.09 5.54 ± 1.01 33.6 ± 5.2*△ 108.2 ± 13.2 51.5 ± 10.1 56.6 ± 3.9 30.5 ± 2.3 26.1 ± 1.7 0.73 ± 0.21 0.91 ± 0.08 1.55 ± 0.12 5.27 ± 0.63 41.6 ± 5.5 116.1 ± 19.8 53.3 ± 10.7 56.2 ± 4.1 31.0 ± 1.7 25.2 ± 2.3 0.76 ± 0.26 0.96 ± 0.17 1.58 ± 0.22 5.36 ± 1.07 *p < 0.05 versus C group, △p < 0.05 versus 30N group. 30G, 30N, 10G, 10N and C were labeled as in Table 5. Table 7 Organ/body weight in male and female rats following 90 days. (Mean values ± SD, n ¼ 12). 30G Male heart liver spleen lungs kidneys (paired) Female heart liver spleen lungs kidneys (paired) 30N 10G 10N C 0.31 2.86 0.15 0.31 0.61 ± ± ± ± ± 0.02 0.28 0.05 0.07 0.08 0.30 2.72 0.17 0.31 0.65 ± ± ± ± ± 0.04 0.33 0.02 0.04 0.06 0.30 2.52 0.17 0.28 0.64 ± ± ± ± ± 0.03 0.37 0.03 0.06 0.04 0.35 2.63 0.18 0.30 0.64 ± ± ± ± ± 0.04 0.24 0.03 0.08 0.05 0.29 2.74 0.19 0.27 0.63 ± ± ± ± ± 0.06 0.40 0.04 0.11 0.06 0.33 2.70 0.19 0.38 0.68 ± ± ± ± ± 0.04 0.26 0.03 0.04 0.05 0.35 2.75 0.20 0.40 0.66 ± ± ± ± ± 0.04 0.17 0.02 0.06 0.11 0.30 2.82 0.20 0.41 0.69 ± ± ± ± ± 0.05 0.22 0.03 0.06 0.07 0.32 2.72 0.18 0.37 0.68 ± ± ± ± ± 0.04 0.24 0.04 0.04 0.05 0.33 2.63 0.21 0.41 0.68 ± ± ± ± ± 0.02 0.27 0.05 0.03 0.06 Organ/body weight expressed as a percentage of organ weight/body weight. 30G, 30N, 10G, 10N and C were labeled as in Table 5. et al., 2011). HBD3 is an ideal candidate protein to protect the body from bacterial invasion (Roosen et al., 2004). Our group used phiC31 integrase to insert HBD3 into the cattle genome. Mastitis was less prevalent amongst the resulting transgenic cattle and the milk containing HBD3 also repressed the growth of bacteria (Yu et al., 2013). In addition, the HBD3 transgenic cattle were healthy. The sequence of the vector in transgenic cattle was integrated (Yu et al., 2013). The lactation was comparable between the transgenic cattle and the healthy conventional cattle. Compared with antibiotics, HBD3 shows antibacterial activity at very low concentration. HBD3 also expressed at low concentration in the transgenic cattle. It is not easy for pathogens to develop resistance to HBD3. Therefore, it is a better way to prevent dairy cow mastitis by producing the HBD3 transgenic cattle. A recent study assessed the effects of GM milk containing HBD3 on the gastrointestinal health of mice. The study was conducted to evaluate multiple health parameters including general physical examination, gastric emptying function, intestinal permeability, mouse intestinal microflora composition, the possibility of horizontal gene transfer, and in vitro digestion of HBD3 milk. No adverse effects were found on gastrointestinal health resulting from consumption of GM milk containing HBD3. The HBD3 milk was easily digested in a simulated gastric fluid in vitro. Although a slight difference was observed in the mouse intestinal microflora composition, the dominant bacteria species were similar between those animals fed with GM diets and those fed with non-GM diets (Chen et al., 2016). Other feeding studies of transgenic milk containing antimicrobial proteins also resulted in the modulation of intestinal microflora (Hu et al., 2012; Maga et al., 2006). Given the differences in physiological function and structure between rats and mice, different reactions to the same product are possible. Previous studies showed that rats displayed no pathological changes following feeding trials with GM glyphosate- tolerant soybean (Sakamoto et al., 2007). However, other studies showed that some modifications occurred in hepatocyte nuclei of mice fed diets containing GM glyphosate-tolerant soybean (Malatesta et al., 2002, 2005). Therefore, in this study, we conducted a feeding study to evaluate the presence of any unintended adverse effects on rats associated with the consumption of diets containing GM milk at different doses. The results showed there was no difference in the composition of GM and conventional milk. The body weight, food consumption, relative organ weight, and histopathology of each group were normal and no statistical differences were observed between groups. Significant differences were observed between groups for some blood biochemistry parameters, e.g., ALT activity. The ALT levels in female rats of the 30G and 10N groups were slightly lower than those of the C group. Many studies have shown that ALT activity undergoes significant diurnal variation, and ALT activity in the afternoon can be up to 45% higher than its activity in the morning (Cordoba et al., 1998). In this study, the difference observed in ALT level may be the result of differences in the timing of blood collection. In addition, ALT level typically declines as liver fibrosis progresses (Kim et al., 2008). However, the liver histopathological results of female rats in 30G and 10N groups revealed that the tissue did not contain lesions. In general, ALT levels less than fivefold the upper limit of the normal range should be verified (Kim et al., 2008). All the analyzed parameters were within the normal range for rats of this age. Thus, we consider that the differences in ALT level in female rats of the 30G and 10N groups are not biologically significant. The TG level in male rats of the 30G group was slightly lower than that in the C group. In terms of pathological condition, a declining level of the TG value is accompanied by decreased body weight (Gavino et al., 2000). However, the body weights of male rats of the 30G group were not decreased during the study. In addition, the TG level in male rats of the 30G group was within the normal range. High-concentration 40 X. Chen et al. / Food and Chemical Toxicology 100 (2017) 34e41 We used somatic cell count meter (KangDaZhiXin KD-400, China) to count the somatic cells in the transgenic milk. There were 232,000 cells per milliliter milk on the average, which was within the normal range. Somatic cells in the transgenic milk could express EGFP. However, the amount of EGFP in the transgenic milk was few to detect using western bloting. Therefore, we did not consider the effect from EGFP. In this study, no rats showed pathologic changes after they consumed approximately maximum 5876.405 mg HBD3. As no feeding study reports the total consumption of HBD3 by rats, this result may be a guide for the future feeding studies of HBD3. In summary, based on the principles of the GM product safety assessment and other previous studies, we conducted a study to assess the composition of GM milk and the general health of rats fed GM milk in their diet. The results showed that GM milk composition was normal and did not significantly differ to the composition of conventional milk. In addition, the results showed that all rats were healthy during the feeding trial. Thus, GM milk containing HBD3 did not have any adverse effects on rats. Competing financial interests The authors declare that there are no competing financial interests. Author contributions Conceived and designed the experiments: XC, MG, and YZ. Performed the experiments: XC, MG, DL, SY, KY, and YZ. Analyzed the data: XC and MG. Wrote the paper: XC. Acknowledgements Fig. 2. Histopathological results of main organs by HE staining. (A) Male rats; (B) Female rats. Scale bar ¼ 100 mm. 30G, 30N, 10G, 10N and C were labeled as in Fig. 1. This work was supported by the National Major Project for Production of Transgenic Breeding (No. 2013ZX08007-004). Appendix A. Supplementary data TBIL serves as a marker of hepatobiliary disorders. Serum concentrations of TBIL within the physiological range were shown to be inversely associated with metabolic syndrome (Choi et al., 2013). In metabolic syndrome, a lower value for TBIL is accompanied by higher values for ALT, TG, and CHOL (Wu et al., 2011). However, ALT, TG, and CHOL concentrations in male rats of the 30G group were lower than those in the control group. Therefore, the differences observed in TG and TBIL levels were not an evidence that HBD3 milk is unsafe. No rats exhibited clinical symptoms during the feeding trial. In previous studies, differences were also observed in the blood biochemistry parameters of different feeding groups (Chen et al., 2016; Yuan et al., 2013; Zou et al., 2016). The transgenic milk is mainly applied to change milk ingredients more closely to the human milk, to produce pharmaceutical proteins as mammary gland bioreactor, and to improve the resistance of mastitis (X. Liu et al., 2014; Wang et al., 2008; Yang et al., 2011). Although there may be several physiological indexes different with those of the corresponding control group, feeding studies of different transgenic milk did not show a detrimental effect on the consumer health. All experimental animals survived the duration of the feeding trial and no histopathological changes were found (Chen et al., 2016; Hu et al., 2012; Zhou et al., 2011). Males and females display physiological differences in many areas including immune responses and reproduction (Ansar et al., 1985). Therefore, they may have different responses to the same stimulus. In this study, no differences were observed between male and female rats for any of the analyzed parameters. Supplementary data related to this article can be found at http:// Transparency document Transparency document related to this article can be found online at References Ansar, Ahmed, S., Penhale, W.J., Talal, N., 1985. Sex hormones, immune responses, and autoimmune diseases. Mechanisms of sex hormone action. Am. J. Pathol. 121 (3), 531e551. Appenzeller, L.M., Munley, S.M., Hoban, D., Sykes, G.P., Malley, L.A., Delaney, B., 2008. Subchronic feeding study of herbicide-tolerant soybean DP-356O43-5 in Sprague-Dawley rats. Food Chem. Toxicol. 46 (6), 2201e2213. Calsamiglia, S., Hernandez, B., Hartnell, G.F., Phipps, R., 2007. 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Factors involved in the early pathogenesis of bovine Staphylococcus aureus mastitis with emphasis on bacterial adhesion and invasion. A review. Vet. Q. 24 (4), 181e198. Kim, W.R., Flamm, S.L., Di Bisceglie, A.M., Bodenheimer, H.C., Public Policy Committee of the American Association for the Study of Liver, D., 2008. Serum activity of alanine aminotransferase (ALT) as an indicator of health and disease. Hepatology 47 (4), 1363e1370. Liu, J., Luo, Y., Ge, H., Han, C., Zhang, H., Wang, Y., Zhang, Y., 2013. Anti-bacterial activity of recombinant human beta-defensin-3 secreted in the milk of transgenic goats produced by somatic cell nuclear transfer. PLoS One 8 (6), e65379. Liu, S., Li, C.X., Feng, X.L., Wang, H.L., Liu, H.B., Zhi, Y., Xu, H.B., 2013. Safety assessment of meat from transgenic cattle by 90-day feeding study in rats. Food Chem. Toxicol. 57, 314e321. Liu, X., Wang, Y., Tian, Y., Yu, Y., Gao, M., Hu, G., Zhang, Y., 2014. Generation of mastitis resistance in cows by targeting human lysozyme gene to beta-casein locus using zinc-finger nucleases. Proc. Biol. Sci. 281 (1780), 20133368. Maga, E.A., Walker, R.L., Anderson, G.B., Murray, J.D., 2006. Consumption of milk from transgenic goats expressing human lysozyme in the mammary gland results in the modulation of intestinal microflora. Transgenic Res. 15 (4), 515e519. Maisetta, G., Batoni, G., Esin, S., Florio, W., Bottai, D., Favilli, F., Campa, M., 2006. In vitro bactericidal activity of human beta-defensin 3 against multidrugresistant nosocomial strains. Antimicrob. Agents Chemother. 50 (2), 806e809. Malatesta, M., Caporaloni, C., Gavaudan, S., Rocchi, M.B., Serafini, S., Tiberi, C., Gazzanelli, G., 2002. Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Cell Struct. Funct. 27 (4), 173e180. 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Innate immune response of bovine mammary gland to pathogenic bacteria responsible for mastitis. J. Infect. 54 (4), 399e409. Quinones-Mateu, M.E., Lederman, M.M., Feng, Z., Chakraborty, B., Weber, J., Rangel, H.R., Weinberg, A., 2003. Human epithelial beta-defensins 2 and 3 inhibit HIV-1 replication. AIDS 17 (16), F39eF48. Roosen, S., Exner, K., Paul, S., Schroder, J.M., Kalm, E., Looft, C., 2004. Bovine betadefensins: identification and characterization of novel bovine beta-defensin genes and their expression in mammary gland tissue. Mamm. Genome 15 (10), 834e842. Sakamoto, Y., Tada, Y., Fukumori, N., Tayama, K., Ando, H., Takahashi, H., Kamimura, H., 2007. A 52-week feeding study of genetically modified soybeans in F344 rats. Shokuhin Eiseigaku Zasshi 48 (3), 41e50. Schroder, M., Poulsen, M., Wilcks, A., Kroghsbo, S., Miller, A., Frenzel, T., Knudsen, I., 2007. A 90-day safety study of genetically modified rice expressing Cry1Ab protein (Bacillus thuringiensis toxin) in Wistar rats. Food Chem. Toxicol. 45 (3), 339e349. Scudiero, O., Galdiero, S., Cantisani, M., Di Noto, R., Vitiello, M., Galdiero, M., Salvatore, F., 2010. Novel synthetic, salt-resistant analogs of human betadefensins 1 and 3 endowed with enhanced antimicrobial activity. Antimicrob. Agents Chemother. 54 (6), 2312e2322. Sinha, M.K., Thombare, N.N., Mondal, B., 2014. Subclinical mastitis in dairy animals: incidence, economics, and predisposing factors. ScientificWorldJournal 2014, 523984. Tang, M., Xie, T., Cheng, W., Qian, L., Yang, S., Yang, D., Li, K., 2012. A 90-day safety study of genetically modified rice expressing rhIGF-1 protein in C57BL/6J rats. Transgenic Res. 21 (3), 499e510. Wall, R.J., Powell, A.M., Paape, M.J., Kerr, D.E., Bannerman, D.D., Pursel, V.G., Hawk, H.W., 2005. Genetically enhanced cows resist intramammary Staphylococcus aureus infection. Nat. Biotechnol. 23 (4), 445e451. Wang, J., Yang, P., Tang, B., Sun, X., Zhang, R., Guo, C., Li, N., 2008. Expression and characterization of bioactive recombinant human alpha-lactalbumin in the milk of transgenic cloned cows. J. Dairy Sci. 91 (12), 4466e4476. Wu, Y., Li, M., Xu, M., Bi, Y., Li, X., Chen, Y., Wang, W., 2011. Low serum total bilirubin concentrations are associated with increased prevalence of metabolic syndrome in Chinese. J. Diabetes 3 (3), 217e224. Yamaguchi, M., Ito, Y., Takahashi, S., 2007. Fourteen-week feeding test of meat and milk derived from cloned cattle in the rat. Theriogenology 67 (1), 152e165. Yang, B., Wang, J., Tang, B., Liu, Y., Guo, C., Yang, P., Li, N., 2011. Characterization of bioactive recombinant human lysozyme expressed in milk of cloned transgenic cattle. PLoS One 6 (3), e17593. Yu, Y., Wang, Y., Tong, Q., Liu, X., Su, F., Quan, F., Zhang, Y., 2013. A site-specific recombinase-based method to produce antibiotic selectable marker free transgenic cattle. PLoS One 8 (5), e62457. Yuan, Y., Xu, W., He, X., Liu, H., Cao, S., Qi, X., Luo, Y., 2013. 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ASSIGNMENT - SWOT Analysis in the Life Sciences (100 points/10%) Addresses Course Outcomes 1, 2, 3 and 4:  Interpret and critically analyze primary scientific literature to assess the validity and reliability of scientific results and evaluate the conclusions drawn from these data  Demonstrate proficiency in scientific principles, techniques and applications in the life sciences to evaluate experimental design and determine compliance with standards of protocol and ethical practice  Effectively communicate scientific principles, concepts, methods, and research findings based on critical analysis of primary literature, industry reports, and other life sciences resources  Pose vital and relevant scientific questions to identify problems, challenges, and opportunities for the development of innovative products and services in the life sciences SWOT, which represents Strengths, Weaknesses, Opportunities and Threats, is an analysis that is often used during strategic business planning. It can serve as a precursor to any sort of company action, such as exploring new initiatives or identifying possible areas for change. SWOT's primary objective is to help organizations develop a full awareness of all the factors involved making in a decision. Although at first glance the SWOT analysis seems more fitting for a business course, its application in biotechnology is very valuable. Many start-up companies or new products and services in the life sciences are initiated by researchers who recognize challenges and opportunities to investigate complex phenomena and, in the process, make new discoveries, encounter seemingly insurmountable technical problems, or recognize an opportunity to serve other industries. The SWOT analysis enables these researchers to identify both internal influences (strengths and weaknesses) and external influences (opportunities and threats) that will have an impact on their identified opportunity. This process is often based on the observations gleaned from primary scientific literature – the first step in the scientific method. Recall from last week’s critical analysis assignment that assessing the authenticity of the research findings by careful critical analysis serves to broaden the understanding of the subject matter, and provide a background for conducting further study. This week you will apply your ability to read and critically analyze primary scientific literature to identifying future research challenges and/or opportunities for which you will employ a SWOT analysis. For this assignment, you will read primary article B which is based on a specific area of biotechnology. You will also read a few resources that will help you think creatively and innovatively before you complete the SWOT analysis. You will then analyze and critique the article for its innovative potential in one of four areas: 1) development of a new research method 2) development of a new research project 3) development of a new product 4) development of a new service THE ASSIGNMENT Imagine that you are the CEO of a biotechnology company looking to invest in a new research method, a new research project, a new product, or a new service. You have just read an interesting primary research article (primary article B, which will be provided) and you are evaluating its potential for innovation. After reading primary article B, as well as the SWOT analysis resources, please address each of the following items. I. Paper Format (10 points) A. Title page: Name, Course Name, Instructor Name, Paper Title, Due Date (2.5) B. Sections of paper numbered and labelled properly (2.5) C. Type double-spaced, 11-point, Times New Roman font paper with 1-inch margins (2) D. 3-4 pages (not including title page and reference page) (3) II. Paper Content (70 points) SWOT Analysis - Label each section of your paper according to the labels A-B below. A. Introduction (20 points) 1. Summary (5) - summarize primary article B including the observations, question, hypothesis, experiment, results, and conclusion of the article. 2. Eureka! moment (5) - In 4-5 sentences, describe a Eureka! moment - an aspect of the research (introduction, materials, methods, results, discussion, conclusion) that stood out as you read primary article B that you believe could lead to an innovative research method, project, product, or service. 3. Innovation (5) – Read all of the required resources and watch the required videos listed below on the topics of innovation and creativity. Make notes about key take-away messages (you need not submit these notes.) Apply what you have learned from the videos and slides to fully and specifically explain your innovative method, service, product, or research based on the Eureka! moment you have identified. 4. Creativity (5) - explain the ways in which your innovative method, research, product, or service is creative and can contribute to the biotechnology field. B. SWOT Analysis (50 points) – Based on your proposed innovative method, research, product, or service, fill in the SWOT Analysis Template provided below and embed it into your paper. Use the provided SWOT Analysis Questions to guide you as you fill in the template. 1. Strengths (10) Explain any internal resources that would make the innovation possible 2. Weaknesses (10) Explain any internal factors that could hinder innovation 3. Opportunities (10) Explain any external factors that could contribute to the success of your innovation 4. Threats (10) Explain any external threats that could hinder the success of your innovation 5. SWOT Analysis summary (10) - Present a similar or related method, research, product, or service to your chosen innovation from at least two additional recent primary journal articles. Based on the recent primary literature, what do you regard as the most promising aspect of your proposed innovation and what do you regard as the biggest threat to the future of your proposed innovation? (Be sure to cite the resources) III. Paper References (15 points) If no references are cited, a grade of zero for this assignment will be awarded. A. Use at least 10 references (5) All references should be cited throughout the paper: DO NOT USE WIKIPEDIA B. In-text references in APA format (5) C. End references in APA-format (5) IV. Paper Grammar (5 points) Spelling, punctuation, capitalization, sentence construction, and paragraph construction will be considered in the grading of this assignment. Please submit your paper as a Word document to the appropriate assignment folder. Please label your paper with your first name, last name and SWOT Analysis. For example: Sharon Brown – SWOT Analysis. Read primary article B SWOT ANALYSIS RESOURCES Innovation in 5 Minutes Short Practical Steps to Developing an Innovator’s DNA (Slide Presentation): What is Creativity and Innovation? Use the resources listed below to help you choose a specific area of interest for the opportunities section of the assignment: Career Trends Service Trends Technology Trends Future Technologies That Will Change the World OR technology SWOT ANALYSIS TEMPLATE – FILL IN AND EMBED IN YOUR PAPER Internal Strengths 1. Weaknesses 1. External Opportunities 1. Threats 1.

Tutor Answer

School: Carnegie Mellon University



Development of a New Research Project
Student’s Name




Mastitis is a common disease among dairy cattle that leads to decreased quality and
quantity of milk. Transgenic technology is used to interbreed cattle, and the practice has farreaching implication on the quality of dairy products. Cite conducted research to evaluate the
safety of genetically produced milk. The purpose of the study was to assess the nutritional
composition of HBD3 milk produced by transgenic cattle. Rats were used as the test animals for
this particular study. The authors had hypothesized that there would be a disparity in the
nutritional composition of the two milk varieties (Chen et al., 2017). An after 90 days feeding
intervention, the results of the study revealed no nutritional difference between HBD3 milk and
the conventional milk.
The research starts with a brief description of the study and a review of existing literature
to review what other scholars have researched. The research gap is proposed in the introduction.
The methods and material section review the subjects used in the study and the procedure used.
The results section documents the findings of the study in a chronological manner with a brief
description of how statistical analysis was conducted. The discussion section relates the findings
of the research with what is already known about the topic
The research study eyes to introduce a new research project and precisely the nutritional
composition of milk with HBD3. Transgenic cattle have HBD3 in their milk, and the compound
has been pivotal in the prevention of mastitis among daily cattle.



Existing literature shows that milk with HBD3 is also pivotal in inhibiting the microbial
activity of certain strains of bacteria that are responsible for causing various infections. Milk
with HBD3 is believed to be vital in preventing gastrointestinal difficulties. Research has also
linked HBD3 with the inhibition of the HIV.
There is sufficient information supporting the validity and reliability of the research
study. HBD3 has the capability of treating mastitis in cows and thus paving the way for use in
biotechnology research. Milk with HBD3 has a higher antimicrobial activity against pathogens
that reduce the quality and quantity of milk. HBD3 acts by inhibiting the growth of any strains of
bacteria that cause mastitis (Chen et al., 2017). The sample population was relatively sufficient
to observe the desired outcomes. The researchers conducted the study for a total of 90 days
which in this case is adequate time to evaluate the desirable outcomes. If the timing of
intervention is short and there is a high likelihood that the results of the study cannot be
generalized for any other group.
The outcomes of the research did not reveal any insight into the viability and practicality
of the project. After the experiment, it was evident that there was no difference in the nutritional
composition of HBD3 milk and conventional milk. Genetically produced products ought to be
tested before any research is conducted to test their suitability in a research project (Chen et al.,
2017). However, these tests are prone to errors and may off...

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