With the development of antibody manufacturing technology and improvement of new drug research in domestic industry, more innovative monoclonal antibody products submitted investigational new drug (IND) application. At the same time, monoclonal antibody products from abroad which have been approved marketing authorization and/or conducted clinical trials submitted IND applications in China. The National Medical Products Administration (NMPA) issued the "Guideline of Investigational New Drug Application" (No. 16, 2018) which emphasized the chemical, manufacturing, and control (CMC) regulatory, and dossier requirements in IND application, greatly promoted the application quality of innovative biological products. However, compared to the Food and Drug Administration (FDA) and European Medicines Agency (EMA), our particular guidelines are insufficient, such as guideline on virus safety evaluation of biotechnological investigational medicinal products. This review investigated the questions raised by sponsors from 2018 to 2020, including the end of production cell (EOPC) and/or unprocessed bulk (UPB) testing and virus removal or inactivation validation. Meanwhile, sponsors submitted different dossiers due to differences in understanding of stage requirements of guidelines from domestic and abroad. Based on the guidelines of virus safety from NMPA, FDA, and EMA, and the technical considerations, this review puts forward personal suggestions on the adventitious agents testing and virus removal or inactivation validation in manufacturing process, aim to ensure virus safety of innovative monoclonal antibody products in clinical trials.

Objective To explore an algorithm to define the threshold value for tumor contouring on 18F-fluorodexyglucose (FDG) PET imaging. Methods A National Electrical Manufacturing Association (NEMA)NU 2 1994 PET phantom with 5 spheres of different diameters were filled with 18F-FDG. Seven different sphere-to-background ratios were obtained and the phantom was scanned by Discovery LS 4. For each sphere-to-background ratio, the maximum standardized uptake value ( SUVmax ) of each sphere, the SUV of the border of each sphere ( SUVborder ), the mean SUV of a 1 cm region of background (SUVbg) and the diameter (D) of each sphere were measured. SPSS 13.0 software was used for curve fitting and regression analysis to obtain the threshold algorithm. The calculated thresholds were applied to delineate 29 pathologically confirmed lung cancer lesions on PET images and the obtained volumes were compared with the volumes contoured on CT images in lung window. Results The algorithm for defining contour threshold is TH% = 33.1% + 46.8% SUVbg/SUVmax + 13.9%/D ( r = 0.994) by phantom studies. For 29 lung cancer lesions, the average gross tumor volumes ( GTV ) delineated on PET and CT are ( 7.36 ± 1.62 ) ml and (8.31 ±2.05) ml, respectively (t = -1.26, P＞0.05). Conclusion The proposed threshold algorithm for tumor contouring on PET image could provide comparable GTV with CT.

Objective To investigate the expression and clinical significance of ROC1 in ovarian cancer tissues ,to provide new ideas for the gene therapy of ovarian cancer .Methods 261 women with ovarian cancer underwent resection from December 2005 to December 2007 in the Affiliated Hospital of Zunyi Medical College and with 5 years follow-up were enrolled .ROC1 mRNA transcription and protein expression level of ovarian cancer tissue and surrounding normal tissue were tested ,and later the correla-tion between the results and patient′s prognosis was statistically analyzed .Results ROC1 in ovarian cancer tissue was over-ex-pressed ,but almost no expression in surrounding normal ovarian carcinoma ;ROC1 expression levels had a negative correlation with the survival rate of the patients .Conclusion ROC1 in ovarian cancer tissue was over-expressed ,but almost no expression in sur-rounding normal ovarian carcinoma ;ROC1 expression levels had a negative correlation with the survival rate of the patients .

Objective To investigate the effect of mycobacterium tuberculosis heat shock protein 70(TB .HSP70) as an adjuvant carrier on stimulating hepatitis B virus (HBV) core antigen(HBcAg)specific immune response to an accompanying cytotoxic T lym-phocytes epitope peptide from HBV core antigen in vitro .Methods Recombinant proteins HSP70(P1)、HSP70-HBcAg(18-27) (P2)、HSP70-PreS2B (18-24)-PreS2Th(37-53)-HBcAg(18-27)(P3) were expressed in methylotropic yeast Pichia pastoris GS115 . The expression of recombinant proteins was identified by SDS-PAGE and Western blot .The effect of recombinant proteins on den-dritic cell and lymphocytes of chronic HBV infection volunteers was investigated in vitro .The maturation of dendritic cell was meas-ured by flow cytometry ;the secretion of Th1 cytokines such as IL-12p70 ,IL-1β,TNF-αand IFN-γ was measured by ELISA ;the proliferation of lymphocytes was measured by TdR-3H ;the HBV-spesific cytotoxic activity was measured by the classic 51 Cr .Re-sults The recombinant proteins (P1 ,P2 ,P3) were constructed successfully .P1 ,P2 ,P3 could activate dendritic cell from chronic HBV infection volunteers by upregulation CD1a ,CD40 ,CD86 and production Th1 cytokines such as IL-12p70 ,IL-1β and TNF-α. Especially P3 could better induce autologous T cells to generate HBV specific cytotoxic T lymphocytes response ,activate the prolif-eration of lymphocytes and release IFN-γeffectively .However ,the recombinant HSP70 showed no target cell killing and could not induce immune response effectively .Conclusion TB .HSP70 can be used as an adjuvant carrier to stimulate HBV specific immune response to an accompanying cytotoxic T lymphocytes epitope peptide from HBV core antigen ,and enhance immunogenicity of the cytotoxic T lymphocytes epitope peptide .The P3 with B-and T-epitope can activate the HBV specific immune response effectively .

AIM: To observe clinical efficacy of the intravitreal injection of conbercept treatment for exudative age -related macular degeneration.
METHODS:Prospective study. Totally 112 senile patients (112 eyes) with exudative macular degeneration were randomly divided into study group and the control group, 56 cases in each group. The study group were treated with intravitreal injection of conbercept. The control group received conservative treatment. Uncorrected visual acuity and foveal retinal thickness were observed before and after treatment in the two groups.
RESULTS: Visual acuity of study group improved significantly, and the most obvious improvement was observed at 6mo after treatment. Foveal retinal thickness of study group was reduced after treatment, and the most obvious decrease was observed at 6mo after treatment.CONCLUSION: Intravitreal injection of conbercept can improve visual acuity reduced foveal thickness in senile patients with exudative age - related macular degeneration.

Objective To study the effect of personality characteristics on the quality of life in asthma patients. Methods A total of 769 cases asthma patients were investigated by schedule table EPQ-RSC, AQLQ. With the SPSS10.0, t-test, correlation analysis and multivariable stepwise regression analysis were carried out for the collected data. Results ①The total level of life quality of asthma patients was worse. ②The quality of life of asthma patients was related negatively to dimension N of personality characteristics, and it was related positively to dimension E of personality characteristics. ③ Dimension N of personality characteristics entered the regression equation of quality of life. Conclusion Dimension N of personality characteristics is an important factor for affecting the quality of life in asthma patients.

Gas chromatography with mass spectrum detector ( GC-MSD) coupled with purge-and-trap system was set up to analyze the concentration of isoprene in natural waters. The best experimental conditions were established, including purge gas flow rate ( 50 mL/min ) , purge time ( 15 min ) , the optimum capillary column ( Rt-Alumina BOND/KCl) and the appropriate condition of temperature programming. When analyzing isoprene in natural waters, the precision was <4% (n=6), the detection limit was 0. 5 pmol/L and the recovery was 91%-102%. The preservative experiment showed that there was no obvious variation in sample concentrations of isoprene within 60 days. The concentrations of isoprene measured with the method ranged from 60 . 8 to 278 . 7 pmol/L in the Jiaozhou Bay and its adjacent river estuaries and from 44 . 7 to 77 . 2 pmol/L in Yellow River estuary, which was in good accord with those results reported in literatures in other coastal waters. In conclusion, the analytical method could meet the requirements of the analysis of concentration of isoprene in natural waters.

Objective To assess the clinical value and safety of VenaTech LP permanent inferior vena cava filter (IVCF) for preventing pulmonary embolism (PE) in patients with deep vein thrombosis (DVT). Methods One hundred and seven DVT patients receiving VenaTech LP permanent IVCF implantation from October 2005 to November 2009 were selected. In hospital and following up data were analyzed. Results All the filters were successfully implanted. No symptomatic PE took place during acute stage of thrombosis after filter implantation. No complication took place during following up 1 to 36 months.Conclusion Implantation of VenaTech LP permanent IVCF is safe and effective in the prevention of PE.

Difference between transcranial magnetic stimulation and transcranial direct current stimulation in theory, safety, detection of brain function and clinic treatment were reviewed in order to help reasonably select and effectively apply them in clinic.

The plants in genus Gentianella Moench (Gentianaceae) which comprised approximately 250 species, are mainly distributed in temperate regions of the world.Many Gentianella plants are intensely bitter and employed in traditional medicine to stimulate appetite, treat disorders of the gallbladder, and treat fever like the other bitter gentians in various regions of the world.Some species exhibit other remarkable therapeutic effects in the treatments of obesity,diabetes, and heart diseases.Eleven iridoids, twenty-eight xanthones, three C-glucoflavonoids, and eight other compounds have been isolated from the genus.Most of these compounds are associated with antimicrobial,anti-inflammatory, anti-oxidant, hypoglycemic, and antitumor activities, which provide an empirical base for the traditional utilization of the plants in genus Gentinella Moench.