Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.

The objective of this study was to develop fermented vegetable juices that possess antidiabetic and antioxidant activities. Lactobacillus plantarum MKHA15 (MKHA15) and Leuconostoc mesenteroides MKSR (MKSR) were applied to ferment onion, cabbage, and tomato juices at 37℃ and 30℃ for 72 h, respectively, and their functionality was tested using the 12 h hour-fermented juice by MKHA15, and 48 h hour-fermented juice by MKSR. Inhibition of α-glucosidase activity was observed in all fermented juices. The onion juice fermented by MKHA15 showed significantly higher α-glucosidase inhibition activity compared to other juices. All juices showed more than 70% inhibition of α-amylase activity. The DPPH radical scavenging activity of onion juice fermented by MKSR showed significantly lower activity than cabbage and tomato juices; however, no difference was observed between the types of starter cultures. The SOD-like activity of cabbage juice fermented by MKSR was the highest among the fermented juices. The juices fermented by MKHA15 showed higher reducing power than those by MKSR. Therefore, we believe that cabbage, onion and tomato juice fermented by MKHA15 and MKSR would be useful in probiotic juices, as they possess antidiabetic and antioxidant activities.
Brassica ; Fruit and Vegetable Juices ; Lactobacillus plantarum ; Lactobacillus ; Leuconostoc ; Lycopersicon esculentum ; Onions ; Probiotics ; Vegetables

This study compared the predictive models for the growth kinetics of Staphylococcus aureus in ham rice balls. In addition, a semi-quantitative risk assessment of S. aureus on ham rice balls was conducted using FDA-iRISK 4.0. The rice was rounded with chopped ham, which was mixed with mayonnaise (SHM), soy sauce (SHS), or gochujang (SHG), and was contaminated artificially with approximately 2.5 log CFU·g⁻¹ of S. aureus. The inoculated rice balls were then stored at 7℃, 15℃, and 25℃, and the number of viable S. aureus was counted. The lag phases duration (LPD) and maximum specific growth rate (SGR) were calculated using a Baranyi model as a primary model. The growth parameters were analyzed using the polynomial equation as a function of temperature. The LPD values of S. aureus decreased with increasing temperature in SHS and SHG. On the other hand, those in SHM did not show any trend with increasing temperature. The SGR positively correlated with temperature. Equations for LPD and SGR were developed and validated using R² values, which ranged from 0.9929 to 0.9999. In addition, the total DALYs (disability adjusted life years) per year in the ham rice balls with soy sauce and gochujang was greater than mayonnaise. These results could be used to calculate the expected number of illnesses, and set the hazard management method taking the DALY value for public health into account.
Hand ; Kinetics ; Methods ; Public Health ; Risk Assessment ; Safety Management ; Soy Foods ; Staphylococcus aureus ; Staphylococcus

Recently, there has been a growing demand for natural preservatives because of increased consumer interest in health. In this study, we produced Lactobacillus rhamnosus cell-free supernatant (LCFS) and evaluated and compared its antimicrobial activity with existing natural preservatives against pathogenic microorganisms and in chicken breast meat contaminated with Escherichia coli and Staphylococcus aureus. Lactobacillus rhamnosus cell-free supernatant possessed 30 units of lysozyme activity and contained 18,835 mg/L of lactic acid, 2,051 mg/L of citric acid and 5,060 mg/L of acetic acid. Additionally, LCFS inhibited the growth of fourteen pathogenic bacteria, S. aureus, Bacillus cereus, Listeria monocytogenes, Vibrio parahaemolyticus, Listeria innocua, S. epidermidis, L. ivanovii, E. coli, Pseudomonas aeruginosa, Shigella sonnei, Shi. flexneri, Proteus vulgaris, Pseudomonas fluorescens, and Klebsiella pneumoniae. The antibacterial activity of LCFS was stronger than that of egg white lysozyme (EWL), Durafresh (DF) and grapefruit seed extract (GSE). Additionally, LCFS maintained its antimicrobial activity after heat treatment at 50℃~95℃ and at pH values of 3~9. Moreover, LCFS inhibited the growth of E. coli and S. aureus in chicken breast meat. In conclusion, it is expected that LCFS, which contains both lysozyme and three organic acids, will be useful as a good natural preservative in the food industry.
Acetic Acid ; Bacillus cereus ; Bacteria ; Breast ; Chickens ; Citric Acid ; Citrus paradisi ; Egg White ; Escherichia coli ; Food Industry ; Hot Temperature ; Hydrogen-Ion Concentration ; Klebsiella pneumoniae ; Lactic Acid ; Lactobacillus rhamnosus ; Lactobacillus ; Listeria ; Listeria monocytogenes ; Meat ; Muramidase ; Proteus vulgaris ; Pseudomonas aeruginosa ; Pseudomonas fluorescens ; Shigella sonnei ; Staphylococcus aureus ; Vibrio parahaemolyticus

The survival rate after lung transplantation has increased in recent years, leading to an increase in non-pulmonary conditions that require surgical intervention. These post-transplant surgical procedures, however, are associated with high mortality and morbidity rates. Intra-abdominal conditions are the most common reasons for surgical intervention. We describe here two patients who underwent abdominal surgery under general anesthesia following lung transplantation. One patient underwent cholecystectomy due to cholecystitis after heart-lung transplantation, and the other patient had an exploratory laparotomy for duodenal ulcer perforation after double lung transplantation. Depending on the type of transplant intervention, the physiology of the transplanted lung must be considered for general anesthesia. Knowledge of underlying conditions and immunosuppressive therapy following transplantation are important for safe and effective general anesthesia.
Anesthesia* ; Anesthesia, General ; Cholecystectomy ; Cholecystitis ; Duodenal Ulcer ; Heart-Lung Transplantation ; Humans ; Laparotomy ; Lung ; Lung Transplantation* ; Mortality ; Physiology ; Survival Rate

BACKGROUND/OBJECTIVES: We investigated total 26 ingredients of Saengshik which will be commercially produced as an anti-diabetic dietary supplement. SUBJECTS/METHODS: Thirteen vegetables, nine cereals, three legumes and one seed were extracted with aqueous ethanol for 2 h at 60degrees C, and evaluated for their inhibitory effects against alpha-amylase and alpha-glucosidase and for total phenolic and flavonoid contents. RESULTS: All ingredients inhibited alpha-amylase activity except cabbage. Strong inhibitory activity of alpha-amylase was observed in leek, black rice, angelica and barley compared with acarbose as a positive control. Stronger inhibition of alpha-glucosidase activity was found in small water dropwort, radish leaves, sorghum and cabbage than acarbose. All Saengshik ingredients suppressed alpha-glucosidase activity in the range of 0.3-60.5%. Most ingredients contained total phenols which were in the range of 1.2-229.4 mg gallic acid equivalent/g dried extract. But, total phenolic contents were not observed in carrot, pumpkin and radish. All ingredients contained flavonoid in the range of 11.6-380.7 mg catechin equivalent/g dried extract. CONCLUSIONS: Our results demonstrate that Saengshik containing these ingredients would be an effective dietary supplement for diabetes.
Acarbose ; alpha-Amylases* ; alpha-Glucosidases* ; Angelica ; Brassica ; Catechin ; Edible Grain ; Cucurbita ; Daucus carota ; Dietary Supplements ; Ethanol ; Fabaceae ; Gallic Acid ; Food, Organic* ; Hordeum ; Oenanthe ; Phenol ; Phenols ; Raphanus ; Sorghum ; Vegetables

BACKGROUND: Rapid fluid warming has been a cardinal measure to maintain normothermia during fluid resuscitation of hypovolemic patients. A previous laboratory simulation study with different fluid infusion rates showed that a fluid warmer using magnetic induction is superior to a warmer using countercurrent heat exchange. We tested whether the simulation-based result is translated into the clinical liver transplantation. METHODS: Two hundred twenty recipients who underwent living donor liver transplantation between April 2009 and October 2011 were initially screened. Seventeen recipients given a magnetic induction warmer (FMS2000) were matched 1 : 1 with those given a countercurrent heat exchange warmer (Level-1 H-1000) based on propensity score. Matched variables included age, gender, body mass index, model for end-stage liver disease score, graft size and time under anesthesia. Core temperatures were taken at predetermined time points. RESULTS: Level-1 and FMS groups had comparable core temperature throughout the surgery from skin incision, the beginning/end of the anhepatic phase to skin closure. (P = 0.165, repeated measures ANOVA). The degree of core temperature changes within the dissection, anhepatic and postreperfusion phase were also comparable between the two groups. The minimum intraoperative core temperature was also comparable (Level 1, 35.6degrees C vs. FMS, 35.4degrees C, P = 0.122). CONCLUSIONS: A countercurrent heat exchange warmer and magnetic induction warmer displayed comparable function regarding the maintenance of core temperature and prevention of hypothermia during living donor liver transplantation. The applicability of the two devices in liver transplantation needs to be evaluated in various populations and clinical settings.
Anesthesia ; Body Mass Index ; Body Temperature Changes ; Hot Temperature ; Humans ; Hypothermia ; Hypovolemia ; Liver Diseases ; Liver Transplantation* ; Living Donors* ; Propensity Score ; Resuscitation ; Rewarming ; Skin ; Transplants

BACKGROUND: Rapid fluid warming has been a cardinal measure to maintain normothermia during fluid resuscitation of hypovolemic patients. A previous laboratory simulation study with different fluid infusion rates showed that a fluid warmer using magnetic induction is superior to a warmer using countercurrent heat exchange. We tested whether the simulation-based result is translated into the clinical liver transplantation. METHODS: Two hundred twenty recipients who underwent living donor liver transplantation between April 2009 and October 2011 were initially screened. Seventeen recipients given a magnetic induction warmer (FMS2000) were matched 1 : 1 with those given a countercurrent heat exchange warmer (Level-1 H-1000) based on propensity score. Matched variables included age, gender, body mass index, model for end-stage liver disease score, graft size and time under anesthesia. Core temperatures were taken at predetermined time points. RESULTS: Level-1 and FMS groups had comparable core temperature throughout the surgery from skin incision, the beginning/end of the anhepatic phase to skin closure. (P = 0.165, repeated measures ANOVA). The degree of core temperature changes within the dissection, anhepatic and postreperfusion phase were also comparable between the two groups. The minimum intraoperative core temperature was also comparable (Level 1, 35.6degrees C vs. FMS, 35.4degrees C, P = 0.122). CONCLUSIONS: A countercurrent heat exchange warmer and magnetic induction warmer displayed comparable function regarding the maintenance of core temperature and prevention of hypothermia during living donor liver transplantation. The applicability of the two devices in liver transplantation needs to be evaluated in various populations and clinical settings.
Anesthesia ; Body Mass Index ; Body Temperature Changes ; Hot Temperature ; Humans ; Hypothermia ; Hypovolemia ; Liver Diseases ; Liver Transplantation* ; Living Donors* ; Propensity Score ; Resuscitation ; Rewarming ; Skin ; Transplants

Food is an essential component of good health and a high quality of life. This is especially true for the elderly, where health and quality of life can vary due to eating issues. This study attempts to measure the satisfaction with food-related life in the elderly of South Korea, while examining differences in social support, depression, isolation, and life satisfaction based on the level of satisfaction with food-related life. Data collection was conducted using one-on-one surveys from December 2011 to January 2012. A total of 390 elderly (aged 65 and over) who live in Korea participated in this study. The results showed that the satisfaction with food-related life was high (3.52 out of 5). The elderly who had company during a meal or a meal preparer showed a higher satisfaction with their food-related life. Social support was high (5.32 out of 7) and the feelings of isolation were low (3.85 out of 5). The average satisfaction with life was 4.42 out of 7, indicating a fair satisfaction with life, while the average depression score was relatively low (8.77 out of 26). In general, the elderly with a higher satisfaction with food-related life had a higher social support and overall satisfaction with their life. On the other hand, the elderly with a lower satisfaction with food-related life generally reported higher levels of depression and isolation. A positive correlation was observed between satisfaction with food-related life, social support, and satisfaction of life, while a negative correlation was found between satisfaction with food-related life, isolation, and depression. The results of this study indicate that managing the satisfaction with food-related life is an important component of mental health in the elderly.
Aged ; Data Collection ; Depression ; Eating ; Hand ; Humans ; Korea ; Meals ; Mental Health ; Quality of Life ; Republic of Korea ; Social Isolation

PURPOSE: This study aimed to examine influence of cognitive function, disease severity and disability on ability to perform activity of daily living (ADL) after ischemic stroke. METHODS: A total of 88 patients with ischemic stroke were recruited from January 1, 2008 to December 31, 2012 and assessed with the standardized cognitive test battery and self-reports about disease severity, disability, and ADL. To analyze the data, ANOVA, Pearson correlation coefficients and multiple regression were conducted using SPSS/WIN program. RESULTS: Significant correlations were found between ADL and visuospatial function, visual memory, executive function, and disability (r=.29~.38). Executive function and disability explained 17.3% of total variability in ADL performance after ischemic stroke. CONCLUSION: Executive function may be a promising target for cognitive rehabilitation after ischemic stroke. Thus, effective therapeutic interventions such as cognitive training for stroke patients should be considered to improve their ability to perform ADL.
Activities of Daily Living* ; Cognition ; Executive Function ; Humans ; Memory ; Rehabilitation ; Severity of Illness Index ; Stroke*