Changchun Keygen Biological Products Co.

Changchun, China

Changchun Keygen Biological Products Co.

Changchun, China
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Su J.,Chinese Institute of Materia Medica | Tang Y.,Chinese Institute of Materia Medica | Shen H.,Changchun Key gen Biological Products Co. | Zhang J.,Chinese Institute of Materia Medica | And 6 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2016

Objective: To evaluate the immunogenicity and safety of a booster dose of Japanese encephalitis vaccine co-administrated with live attenuated varicella vaccine and to provide a scientific basis and guidance for the feasibility of combined vaccination of the two vaccines. Methods: A total of 439 children who met the inclusion and exclusion criteria received either a booster dose of Japanese encephalitis vaccine (JEV) alone (n=200) or a booster dose of Japanese encephalitis vaccine co-administered with live attenuated varicella vaccine (JEV+ LAV) (n=239). Serum samples were collected from each subject before and 35 to 42 days after the second immunization of JEV for the detection of antibodies against Japanese encephalitis. Seroconversion rates, geometric mean antibody titers (GMT) and adverse event rates were compared between the two groups. Results: There were significant differences in the seroconversion rates between JEV and JEV+ LAV groups before the booster vaccination (89.78% vs 63.06%, χ2=38.797, P<0.001). The GMT of JE neutralizing antibodies was 1:19.117 in JEV group and 1:7.129 in JEV+ LAV group before the booster dose of JEV (t=6.618, P<0.001). The seroconversion rates were 96.774% in JEV group and 97.297% in JEV+ LAV group after immunization with no significant differences between them (χ2=0.097, P=0.755). The GMT of JE neutralizing antibodies in JEV group was significantly higher than that of JEV+ LAV group after the second immunization of JEV (1:453.693 vs 1:285.692, t=3.548, P<0.001). Stratification analysis was also conducted among non-susceptible and susceptible population. Both of the two populations showed no significant differences in the seroconversion rate and GMT between the two groups before and after the booster dose vaccination. Safety analysis showed that the adverse event rates of JEV and JEV+ LAV groups were 8.0% and 12.6%, respectively, with no significant differences between them (χ2=2.405, P=0.121). No serious adverse events were observed. Conclusion: Co-administration of Japanese encephalitis vaccine with live attenuated varicella vaccine did not impact the immunogenicity of Japanese encephalitis vaccine and was well tolerated. Copyright © 2016 by the Chinese Medical Association.


Chen H.,China National Biotec Group Company Ltd | Liu X.,China National Biotec Group Company Ltd | Shen H.,Changchun Keygen Biological Products Co. | Ma F.,U.S. Center for Disease Control and Prevention | And 6 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2016

Objective: To evaluate the effectiveness and safety of varicella attenuated live vaccine (VarV) produced by A Co. Ltd. Methods: We selected 3 provinces in China and enrolled 15002 children aged 3-<11 in this random, multicenter study. Participants were randomly divided into two groups; the experimental group and the control group. Every varicella case was collected and recorded to calculate the vaccine efficacy. Vaccine safety was assessed by means of spontaneous report and regular follow-up visits. Results: During the observation period, the incidence of varicella was 0.147% in the experimental group and 1.155% in the control group (P<0.001). The vaccine efficacy was 87.27%. The adverse reaction rate after vaccination was lower than the rates reported in other literatures. Conclusion: The VarV produced by A Co., Ltd. in China was effective and safe in preventing varicella. Copyright © 2016 by the Chinese Medical Association.


Wu B.,Jilin University | Wu B.,Changchun Institute of Technology | Cong Q.,Jilin University | Sun T.,Changchun Keygen Biological Products Co. | And 2 more authors.
Harbin Gongcheng Daxue Xuebao/Journal of Harbin Engineering University | Year: 2016

Considering the huge numbers of internal combustion engines in use worldwide, even a small reduction in the friction of the piston-cylinder sleeve system would greatly impact energy conservation and emission reduction. In this paper, we use the LX-2V engine as a test matrix. First, we applied drag reduction and a wear-resistant stripe pattern on a shell's surface to the main friction pair of the internal combustion engine-piston skirt. We then constructed a three-level and three-factor orthogonal test plan. Under the worst skirt conditions, we analyzed the finite element contact for the standard piston and nine bionic piston models, and obtained and compared the three most typical test indexes. We then used a range analysis method to test and optimize the design. Lastly, we selected a standard piston, a bionic piston with optimum performance, and a piston with an optimum combination on which to carry out a durability bench test of the internal combustion engine. Results show that the bionic piston performs better than the standard piston regarding the unloading of concentrated stress of the piston's oil return hole, drag reduction, and abrasion resistance. The average abrasion loss of the bionic piston was 42.9% less than that of the standard piston. In addition, the average cylinder pressure changing rate of the bionic piston was 50.2% more stable than that of the standard piston. © 2016, Editorial Board of Journal of Harbin Engineering. All right reserved.


Zhang Y.,Changchun Keygen Biological Products Co. | Hao B.-S.,Changchun Keygen Biological Products Co. | Zhao H.-B.,Changchun Keygen Biological Products Co.
Chinese Journal of New Drugs | Year: 2012

Original infection of varicella-zoster virus can induce varicella and then herpes when the virus is activated again. In recent years, with the progress of aging of domestic population, the incidence rate of herpes is increasing apparently, and there is no apparent therapeutic effect to treat post-herpetic neuralgia caused by herpes with antiviral drugs. Therefore, the prevention and therapy of herpes has been attached more and more importance for it has become an important public hygiene issue. The prevention of herpes with vaccine has been accepted by the society widely. In this article, we summarized the causative agent of herpes and the current situation of research and development of vaccine research.


Liang H.-Y.,Changchun Keygen Biological Products Co. | Zou Y.,Changchun Keygen Biological Products Co.
Chinese Journal of New Drugs | Year: 2012

Varicella, a common infectious disease in childhood, is caused by varicella-zoster virus. The initial infection is manifested as varicella, and the virus continues to lurk in the spinal ganglia. When the body is in a pathological condition or the immune function is decreased, it produces shingles. Freeze dried live attenuated varicella vaccine is prepared by varicella-zoster virus strain, and it is the only means of varicella infection prevention. Here, we reviewed the development status of freeze dried live attenuated varicella vaccine at home and abroad and the development trend in the future.


Wang F.,Changchun Keygen Biological Products Co. | Shan X.-F.,Changchun Keygen Biological Products Co. | Dai C.-H.,Changchun Keygen Biological Products Co. | Li Q.,Changchun Keygen Biological Products Co. | And 5 more authors.
Chinese Journal of New Drugs | Year: 2012

Objective: To compare the yield and quality of live attenuated varicella vaccine produced with flask and advanced Cell-Stack. Methods: 2BS cell were cultivated in 4-layer or 10-layer Cell-Stack and flask, inoculated with VZV Oka strain when it grows into thick monolayer, digested by EDTA and collect pathological cell by dilution and centrifugation when lesion rate reached over 70%, then add protective agent and store under -65°C. When it is tested to be qualified, prepare stock solution and semi-finished product by sonication and clarification. Finally transfer to filling and packaging workshop to freeze-dry it. Results: Test results of stock solution and final product produced with Cell-Stack and flask consisted with the requirement of Registration Standard of Live Attenuated Varicella Vaccine. Conclusion: Cell-Stack cultivation method significantly decreased the factory area, increased vaccine's yield, ensured the controllability and stability of vaccine's quality, which is suitable for large scale production of live attenuated varicella vaccine.


Zhang Y.,Changchun Keygen Biological Products Co. | Li H.-Y.,Changchun Keygen Biological Products Co. | Zhao H.-B.,Changchun Keygen Biological Products Co. | Yan L.,Changchun Keygen Biological Products Co. | And 4 more authors.
Chinese Journal of Biologicals | Year: 2015

Objective: To analyze the immunogenicity of live attenuated herpes zoster (HZ) vaccine prepared with Oka strain. Methods: Rhesus monkeys were immunized s. c. with live attenuated HZ vaccine prepared with Oka strain, at virus titers of 5. 46 and 4. 9 IgPFU/ml respectively, and observed for general status, of which the serum samples were collected 2, 4, 8 and 12 weeks and 6, 9 and 12 months after immunization, and determined for antibody level against varicella-zoster virus (VZV) with fluorescent antibody to membrane antigen (KAMA). Results: No adverse reactions were observed after immunization. Roth the antibody positive conversion rates of monkeys 2 weeks after immunization with the vaccine at virus titers of 5. 46 and 4. 9 lgPFU/ml were 100%, while the GMTs 2 weeks after immunization were 111. 7 and 27. 9, and those 4 weeks after immunization reached peak values of 168. 8 and 84. 4, respectively. The antibody titer against VZV were still at high levels 12 months after immunization. Conclusion: Live attenuated HZ vaccine prepared with Oka strain showed good immunogenicity in rhesus monkeys.


Liang H.-Y.,Changchun Keygen Biological Products Co. | Sui B.,Changchun Keygen Biological Products Co. | He B.-S.,Changchun Keygen Biological Products Co. | Liang X.,Changchun Keygen Biological Products Co. | And 4 more authors.
Chinese Journal of Biologicals | Year: 2014

Objective To prepare varicella-zoster virus (VZV) Oka strain by the current and novel methods respectively and compare their multiplicities of infection ( MOIs) and proliferation dynamic difference in 2BS cells. Methods VZV Oka strain of passage 47 prepared by the current (storage in frozen at -70°C in maintain medium containing 2% calf serum) and novel (storage in frozen at -196 °C in virus freezing medium containing 90% calf serum) methods respectively, with which the 2BS cells of passage 37 were infected at various MOIs (0. 000 5, 0. 001, 0. 005, 0. 01, 0. 05 and 0. 1) and observed for CPE. Viruses inoculated at various MOIs and cultured for various hours were harvested and prepared into vaccines, of which the titers in bulk and final product as well as stability at 37 °C were determined by plaque assay to optimize the MOIs of virus seeds prepared by two methods to 2BS cells. Results The CPE of 2BS cells reached a peak value 72 h after infection with vims seed prepared by the current method at MOIs of 0. 01 ∼ 0. 1 and with that prepared by the novel method at MOIs of 0. 001 ∼ 0. 01. The titers of final products of vaccines prepared by the virus harvested by two methods were 4. 4 ∼ 4. 6 lgPFU/ml, which decreased to 3. 8 ∼ 4. 0 lgPFU/ml after storage at 37°C for one week. However, the titers in bulk, final product and after storage at 37°C showed no significant difference, which met the requirements for live attenuated varicella vaccine manufactured by Changchun Keygen Biological Products Co., Ltd. Conclusion The optimal MOIs of VZV Oka strain prepared by the current and novel methods were 0. 01 ∼ 0. 1 and 0. 001 ∼ 0. 01 respectively. However, the virus seed prepared by the novel method was more suitable for the production of varicella vaccine.


Shan X.-F.,Changchun Keygen Biological Products Co. | Wang F.,Changchun Keygen Biological Products Co. | Dai C.-H.,Changchun Keygen Biological Products Co. | Yang M.-B.,Changchun Keygen Biological Products Co. | And 6 more authors.
Chinese Journal of Biologicals | Year: 2014

Objective: To improve the method for preparation of Oka strain as a seed of live attenuated varicella-zoster vaccine so as to increase its titer and prolong the storage period. Methods: The working seeds of Oka strain was prepared by original (virus adsorption infection) and improved (virus mixed infection) methods respectively,then determined for titer and evaluated for stability after storage at -70 ° for 0,1,6 and 12 months by plaque assay. Three batches of vaccine were prepared and subjected to overall control tests. Results: The titers of seeds prepared by virus adsorption infection method and by virus mixed infection method were 6. 6 and 6. 5 lgPFU/ml respectively. The titer of virus prepared by the improved method showed no significant decrease after storage at -70 ° for 12 months, while that by the original method decreased significantly after storage for 6 months. All the control test results of final products of vaccines prepared by the two methods met the relevant requirements, while the virus titers and stabilities at 37 ° showed no significant difference. Conclusion: Both the titer and stability at -70 °C of varicella-zoster vaccine virus seed prepared by virus mixed infection method increased significantly.


Dai C.-H.,Changchun Keygen Biological Products Co. | Wang F.,Changchun Keygen Biological Products Co. | Shan X.-F.,Changchun Keygen Biological Products Co. | Li Q.,Changchun Keygen Biological Products Co. | And 3 more authors.
Chinese Journal of Biologicals | Year: 2013

Objective: To compare the culture effects of human diploid cell 2BS strain with disposable culture flask and with common flask. Methods The 2BS cells at the same concentrations were inoculated into disposable culture flask and small common flask respectively, and incubated at (37 ± 0. 5) °C for 3 d, observed for growth under microscope and counted, then infected with varicella-zoster virus (VZV) Oka strain at a MOI of 0.025-0.05 and incubated at (35 ± 0.5) °C for 3 d. The cells were harvested when CPE reached more than 70% to prepare freeze-dried live attenuated varicella vaccine. Overall control tests were performed on the prepared vaccine according to the standard for registration of live attenuated varicella vaccine and the requirements in Chinese Pharmacopoeia(Volume III, 2010 edition). Results: At the same concentrations for inoculation, the area of 2BS cell culture in disposable culture flask increased as compared with that in common flask, while the total cell count was relatively large. The 2BS cells in disposable flask became adherent rapidly, which were in spindle shape, at high density, with good directivity, clear outline and full cytoplasm, and in even distribution. However, the 2BS cells in common flask became adherent slowly and were uneven in growth. All the quality indexes of vaccines prepared with 2BS cells cultured in both disposable culture flask and common flask met the requirements in Chinese Pharmacopoeia (Volume III, 2010 edition). If the virus titers showed no significant difference, the yield of varicella vaccine prepared with 2BS cells cultured in disposable culture flask increased remarkably. Conclusion: The yield of live attenuated varicella vaccine prepared with 2BS cells cultured in disposable culture flask increased remarkably as compared with that in common flask.

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