During routine Good Manufacturing Practice(GMP) compliance supervision, periodic inspections based on risk control concepts have revealed gaps between the current practices of biologics manufacturers in Jilin Province and the latest domestic and international regulatory standards. These gaps span multiple areas, including facility and equipment design for aseptic product manufacturing, airflow pattern control, cleaning and disinfection practices, environmental monitoring, aseptic process simulation, and personnel gowning procedures. This paper compiles and analyzes these identified issues. Considering the inherent tendency of biological product components to support microbial growth, and based on recent regulatory updates alongside a statistical analysis of aseptic manufacturing deficiencies observed during GMP compliance inspections in Jilin's biologics sector, this paper discusses the future direction for improving aseptic assurance levels. The aim is to provide theoretical support for both future regulatory efforts and the enhancement of aseptic assurance capabilities within enterprises.

Objective:To compare the efficacy between deep continuous irrigation combined with vacuum sealing drainage (VSD) and routine dressing change in treating multidrug-resistant bacterial infections at the surgical wound site in patients with major vascular injury.Methods:A retrospective cohort study was conducted to analyze the clinical data of 28 patients with surgical wound infections by multidrug-resistant bacteria after major vascular injury treated at the First Affiliated Hospital of Henan University of Science and Technology from March 2015 to December 2021. There were 15 males and 13 females, aged 15-65 years [(41.8±12.9)years]. All patients received vascular graft surgery after major vascular injury. Postoperative microbiological culture indicated that the wound infections were caused by Carbapenem-resistant organisms (CRO) or vancomycin- resistant Enterococci (VRE), with no available sensitive antibiotics for treatment. The patients received surgical debridement every five days after vascular graft surgery and were divided into two groups to receive the subsequent treatments including a routine dressing change (routine dressing group, 14 patients) or a deep continuous irrigation combined with VSD (irrigation combined with VSD group, 14 patients). On the first day post-operation and then every 3 days, inflammatory indicators [white blood cell count, neutrophils, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and procalcitonin] were observed in the two groups (repeat tests when a patient′s condition changed). Microbiological cultures were applied with patient samples every 5 days to observe the wound and infection control. Comparisons were made between the two groups regarding the duration to normal levels of inflammatory indicators, duration to negative CRO or VRE cultures, visual analogue score (VAS) before and at 1, 2 and 3 hours after changing the irrigation fluid (changing the dressing), conditions of wound skin grafting or flap repair, and incidences of anastomotic fistula.Results:All patients were followed up for 12-24 months [(14.3±2.4)months], during which no wound redness, rupture, purulent discharge or infection recurrence was noted. The duration to normal levels was (9.4±2.4)days for white blood cells, (9.6±2.8)days for neutrophils, (9.8±3.1)days for CRP, (12.2±3.6)days for ESR, and (7.6±1.9)days for procalcitonin in the irrigation combined with VSD group, significantly shorter than those in the routine dressing group [(15.2±3.1)days, (13.6±3.4)days, (14.2±3.9)days, (19.9±3.3)days, and (12.9±4.1)days, respectively] (all P<0.01). The duration to negative CRO or VRE cultures was (13.9±3.1)days in the irrigation combined with VSD group, significantly shorter than that in the routine dressing group [(19.2±6.9)days] ( P<0.05). The VAS before and at 1, 2 and 3 hours after changing the irrigation fluid was (4.2±0.7)points, (4.1±0.9)points, (4.2±0.9)points and (4.1±0.8)points in the irrigation combined with VSD group, respectively, and was (4.3±0.6)points, (6.9±0.7)points, (5.4±0.9)points and (4.5±0.9)points in the routine dressing group, respectively. The VAS score in the irrigation combined with VSD group was significantly lower than that in the routine dressing group at 1 hour and 2 hours after changing the irrigation fluid (all P<0.01), while no significant differences were found before and at 3 hours after changing the irrigation fluid (all P>0.05). After infection control, 5 patients (35.7%) in the irrigation combined with VSD group required skin grafting or flap repair at the wound site, lower than 11 patients (78.6%) in the routine dressing group ( P<0.01). The incidence of anastomotic fistula was 7.1% (1/14) in the irrigation combined with VSD group, lower than 42.9% (6/14) in the routine dressing group ( P<0.05). Conclusion:When multidrug-resistant bacterial infections occur at the surgical wound site after major vascular injury, deep continuous irrigation combined with VSD performs better than routine dressing change in controlling infection as well as in reducing pain, rate of wound skin grafting or flap repair and incidence of anastomotic fistula, without reliance on antibiotics.

Objective To investigate the correlation between the level of postprandial blood glucose (PBG)and the incidence of coronary artery disease(CAD). Methods Eighty-five patients performed coronary angiography with abnormal blood glucose levels were divided into 3 groups according the blood glucose levels: impaired fasting glucose(IFG)group(28 cases), impaired glucose tolerance(IGT)group(29cases)and diabetes mellitus(DM)group(28 cases). The detection rate and the extent of CAD were observed. The risk factors of CAD in 3 groups such as C-reactive protein(CRP),carotid artery intima-media thickness(CIMT), blood lipids, blood pressure, body mass index(BMI)and the correlation with CAD were analyzed. Results Sixty-two cases were confirmed CAD by coronary angiography. The incidence rate of CAD in IGT group[79.3%(23/29)]and DM group[85.7%(24/28)]was significantly higher than that in IFG group[53.6%(15/28)](P ＜ 0.01). The incidence rate of CAD in DM group was higher than that in IGT group, but there was no significant difference(P ＞ 0.05). The incidence rate of two-lesion and three-lesion in IGT group and DM group were significantly higher than those in IFG group(P＜ 0.01). The incidence rate of two-lesion and three-lesion in DM group were higher than those in IGT group, but there was no significant difference(P＞0.05). The levels of CRP, CIMT, BMI, triacylglycerol(TG)and systolic blood pressure(SBP)were higher and HDL-C was lower in IGT group and DM group than those in IFG group(P ＜ 0.01 or ＜ 0.05).The levels of CRP,TG and SBP were higher in DM group than those in IGT group(P＜0.05). Correlation analysis showed, in IGT group and DM group,2 h PG had significantly positive correlation with CRP, CIMT,B MI, TG(P＜0.05 or＜0.01), and had significantly negative correlation with HDL-C(P＜0.05 or ＜0.01).Conclusions PBG is closely related with the development of CAD.IGT patients should be intervened as early as possible, which can be effective in preventing cardiovascular events.

Objective To explore the potential diferentiation of insulin-secreting cells from muscle derived stem cells.Methods SD rat muscle derived stem cells(MDSCs)were isolated and then induced for 7～12 days with combination inductor.Morphological changes of the induced cells were observed under an inveted microscope.DTZ staining,immunocytochemical staining were conducted to examine the production of insulin.Glucose challenge and radio immunoassay were perfomed to evaluate the function of the aggregates,and RT-PCR was conducted to detect the expression of endocrine gene.Results Typical insulin-producing cells were observed at the end of the protocol(12 days).Ditizone staining and immunohistochemistry for insulin were both positive.Insulin was secreted by these cells in response to different concentrations of glucose stimulation(P