In recent years, the biopharmaceutical industry has grown rapidly, and the market size of monoclonal antibody drugs has increased significantly. Accurate structural characterization and quality control are the supporting technologies for the development of monoclonal antibody drugs. As a significant post-translational modification of antibody drugs, glycosylation has an important influence on its efficacy, stability, and immunogenicity. The existing literature usually uses liquid chromatography-mass spectrometry to perform major glycosylation modifications of monoclonal antibody drugs. Characterization, there are few studies on low-abundance glycosylation, but the characterization and control of low-abundance glycosylation cannot be ignored. In this study, we have established a qualitative and quantitative analysis technology for N-glycans based on RapiFluor-MS reagent-labeled monoclonal antibody drugs. This method has a short sample processing time and high sensitivity. It can not only characterize the main glycoforms of three monoclonal antibody drugs (adalimumab, bevacizumab, and trastuzumab) but also can quantify low-abundance N-glycans. The results of the study showed that the main glycoforms specified in the Pharmacopoeia could be detected in different batches of monoclonal antibody drugs, but the content of N-glycans in different batches of samples is not identical. After that, we analyzed the N-glycans connection sites and glycoforms at the intact glycopeptide level, further enriching the N-glycans structure information of the monoclonal antibody. The qualitative and quantitative analysis technology of N-glycans based on RapiFluor-MS reagent-labeled monoclonal antibody drugs can realize the in-depth characterization and control of glycosylation modification of monoclonal antibody drugs.

The research and development of monoclonal antibodies (mAbs) is a rapidly developing field. From the first generation of murine mAbs to the fourth generation of fully human mAbs, the efficacy and safety of mAbs in the treatment of various diseases have been continuously improved. In order to regulate the development and evaluation of mAbs, drug regulatory agencies and pharmacopeias of America and China have tried to issue feasible test procedures and acceptance criteria for quality evaluation of mAbs and biosimilars. Mass spectrometry (MS) technique with high sensitivity, resolution, selectivity, and specificity has become an important tool to evaluate the quality characteristics of monoclonal antibody-related products or specify mAb quality. The research of MS-based monoclonal antibody study involves structure characterization, impurity analysis, pharmacokinetics/pharmacodynamics (PK/PD), etc. This review focuses on the current quality control requirements of mAb related products and the development of MS technique for mAb quality characterization and specification. It is expected to provide information and references for evaluating the quality of monoclonal antibodies under research and development.

Objective:To understand the current situation of hospital violence medical students experienced during the internship period and their professional identity.Method:With the method of cluster sampling,a questionnaire survey was conducted among 500 medical students from a medical college in Ganzhou,to understand the characteristics of hospital violence and compare the difference between the medical students who experienced violence and those not.Results:The effective recovery rate of questionnaire was 90.8％,of which 61.4％ of medical students had witnessed hospital violence,8.1％ of students had experienced hospital violence;the hospital violence that medical students experienced were characterized by low frequency and emotional violence.The overall score of personal identity was (117.05 ± 19.65),was in a medium level.Among the comparison of personal identity between the medical students who had experienced violence and those not,there was a significant difference in occupational cognition dimension (P ＜ 0.01),but there was no significant difference in the total score and other four dimensions (P ＞ 0.05).Conclusion:We should pay attention to the current situation of hospital violence that students experienced and their professional attitude,carry out targeted training and psychological counseling to improve their ability to respond to hospital violence and enhance their professional identity.

Objective To investigate the efficacy of butylphthalide on elderly patients with acute cerebral infarction and its effect on serum uric acid,c-reactive protein,and hemorheology.Methods Elderly patients (86 cases) with acute cerebral infarction in Xi'an No.1 Hospital from January 2015 to December 2015 were randomly divided into two groups.The control group was treated with conventional symptomatic treatment of acute cerebral infarction,observation group added with butylphthalide soft capsules.The NIHSS score and efficacy of the two groups,the serum uric acid,c-reactive protein,and the change of hemorheology before and after treatment were compared.Results The effective rate of observation group was 90.70％,significantly higher than that of control group 72.09％ (P ＜ 0.05);The NIHSS score,serum uric acid and c-reactive protein levels,blood viscosity and platelet aggregation rate of two groups after treatment were significantly lower (P ＜ 0.05),the Barthel index were significantly increased (P ＜ 0.05),and the change of observation group were more significant (P ＜ 0.05).Conclusion Butylphthalide has high curative effect on elderly patients with acute cerebral infarction,can reduce the level of serum uric acid,c-reactive protein and the degree of nerve function defect,improve the hemorheology and life self-care activities ability,which can protect the brain.

CX-conjugated antigen(BSA-CX) were produced by methods of EDC.The spleen cells of BALB/C mouse immunized by BSA-CX were fused with SP2/0 plasmacytoma cells using PEG4000,and selected cultured with HAT and HT medium.A hybridoma cell line of 2H8-B1-F4 was secreened for specificity to CX,and cloned by limited dilution method for 3 times,which secrete high affinity and stable monoclonal antibodies against CX with indirect ELISA. The antibody was characterized by IgG1 isotype, the titers of antibody in cell supernatant and ascites were 1∶1000 and 1∶4?10~5,respectively.The mAb against CX was selective toward dicloxacillin, oxacillin with cross-reactivity of about 19.6% and 21.3%,which can be used to detect CX residues by competitive ELISA.

Breast Neoplasms ; genetics ; Carcinoma, Ductal, Breast ; genetics ; Female ; Genes, erbB-2 ; Humans ; In Situ Hybridization ; methods ; In Situ Hybridization, Fluorescence ; Silver

Adult ; Diagnosis, Differential ; Female ; Humans ; Keratin-18 ; metabolism ; Mucin-1 ; metabolism ; Omentum ; metabolism ; pathology ; Peritoneal Neoplasms ; metabolism ; pathology ; ultrastructure ; Pregnancy ; Trophoblastic Neoplasms ; metabolism ; pathology ; ultrastructure ; Trophoblastic Tumor, Placental Site ; pathology ; Vimentin ; metabolism

Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects ; Tricuspid Valve Stenosis ; etiology

In view of the predominance problems in present experimental teaching of medical microbiology, we reformed the experimental contents and experimental teaching methods,to establish an entire experimental curriculum teaching system to be suitable for seven-year system and long educational system students,which manifests the creative teaching idea.

Objective To investigate the change of serum Tg levels of DTC patients with positive stimulated Tg (Tg ≥ 10.00 μg/L),negative 131I-diagnostic whole body scan(Dx-WBS) and no distant metastasis 6 months after initial 131I therapy.Methods Fifty-six DTC patients (20 males,36 females,average age 43.11 (21-70) y) with intermediate or low risk of recurrence according to American Thyroid Association (ATA) guideline were enrolled into the retrospective study.All patients were grouped according to stimulated Tg level after initial 131I therapy:group with positive Tg (Tg+ group,n =19) and group with negative Tg (Tgˉ group,n=37).Changes of suppressed Tg at 1 year and 2.5 years (Tg1ysup and Tg2.5ysup) after initial therapy were compared between the two groups.Serum TSH level,TgAb level,neck ultrasound and chest CT results were also evaluated.The two-sample t test and x2 test were used for statistical analysis with SPSS 17.0.Results Stimulated Tg and Tglysup levels in Tg+ group were remarkably higher than those in Tgˉ group:(24.27±4.10) μg/L vs (2.73±3.01) μg/L,t=7.191,P＜0.05(6 months after initial 131I therapy) ; (2.21±0.55) vs (0.48±0.10) μg/L,t=3.102,P＜0.05(1 year after initial 131I therapy),respectively.In Tg+ group,suppressed Tg level decreased with time in 68.4％ (13/19) of patients,of whom the Tg2.5ysup level was much lower than Tglysup level ((0.53±0.15) μg/L vs (1.38±0.50) μg/L).Tg2.5sup level in Tg+ group became comparable to that in Tgˉ group ((1.44±0.52) μg/L vs (0.38±0.07) μg/L; t =2.001,P＞0.05).In each group,one case of recurrence with suppressed Tg of 1.4 μg/L and 0.1 μg/L respectively,was observed using neck ultrasound after 2 years of follow-up.Conclusions Serum Tg levels decreased with time for Tg+/131I-Dx-WBS-DTC patients with intermediate or low risk of recurrence.It might not be necessary to follow up these patients with Tg and 131 I-DxWBS after 6 months of initial 131I therapy.