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Yue S.-L.,Wuhan Institute of Biological Products Co. | Li C.-S.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2017

As the active form of human plasminogen (Plg), plasmin (Plm) is an essential component of fibrinolytic system. The physiological function refers Plg/Plm an extensive prospects of application in clinical therapy. Plg/Plm has been studied in clinical trials. This paper reviews the conversion mechanism, related diseases, main function, pre-clinical/clinical studies and manufacturing process of Plg/Plm.


News Article | November 9, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Rotavirus Infections  ,complete with analysis by stage of development,drug target,mechanism of action (MoA),route of administration (RoA) and molecule type. The report also coversthe descriptive pharmacological action of the therapeutics,its complete research and development history and latest news and press releases. Additionally,the report provides an overview of key players involved in therapeutic development for Rotavirus Infections   and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios,enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Rotavirus Infections - Pipeline Review,H2 2016 addition with 26 market data tables and 13 figures, spread across 62 pages is available at http://www.rnrmarketresearch.com/rotavirus-infections-pipeline-review-h2-2016-market-report.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases,company/university websites,clinical trial registries,conferences,SEC filings,investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally,various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Beijing Minhai Biotechnology Co., Ltd,Bharat Biotech International Limited,Biological E. Limited,Curevac AG ,Medicago Inc. ,MSD Wellcome Trust Hilleman Laboratories Pvt Ltd,Nanotherapeutics, Inc.,Serum Institute of India Limited,Shantha Biotechnics Limited,Sinovac Biotech Ltd.,Takeda Pharmaceutical Company Limited,Wuhan Institute of Biological Products Co., Ltd. Inquire before buying http://www.rnrmarketresearch.com/contacts/inquire-before-buying?rname=748014(This is a premium report price at US$2000 for a single user PDF license).


Wu H.-F.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

Human papillomavirus (HPV) is mainly transmitted through sexual contact, which may lead to cervical cancer as well as anal and genital malignancies. Currently, cervical cancer is the second most common gynecological malignancy worldwide. Effective vaccines for prevention and treatment of HPV infection are of important significance, among which therapeutic vaccines are more attractive. This article reviews the progress in research on therapeutic HPV vaccine.


Hu D.-C.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

The high expression of recombinant antibody in mammalian cells is dependent on the construction of high expression vector, optimization of antibody gene sequence, screening of stable antibody-expressing cell strains, modification of host cells as well as optimization of cell culture process. The progress in research on above-mentioned problems is reviewed in this paper.


Sun W.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2014

Objective: To investigate the tetanus antibody levels in healthy plasma donors in Songzi City, Hubei Province, China. Methods: A total of 539 healthy plasma donors in Songzi City, at ages of 18-55 years, were randomly selected and divided into five age groups (not more than 35, 36-40, 41-45, 46-50 and 51-55 years), of whom plasma samples were collected and determined for serum tetanus antibody level by indirect ELISA. Results: The tetanus antibodies of 479 of the 539 donors reached protective levels, with a positive rate of 88. 9% and an average total content (ATC) of (2.350 ± 3.246) IU/ml. The tetanus antibody positive rates in various groups were nearly 90%, which showed no significant difference (P > 0.05). The positive rate in the donors at ages of not more than 35 years was the highest (89.8%), while that in those at ages of 51-55 years was the lowest (87.8%). However, the ATC was the highest in the donors at ages of 46-50 years [(2. 622 ±3.518) IU/ml], while was the lowest in those at ages of 51-55 years [(1.870 ± 2.947) IU/ml]. The distributions of antibody levels in the donors at ages of 41-45 and 51-55 years showed significant difference (P < 0.05), while those in other age groups showed no significant difference (P > 0.05). Conclusion: Most of healthy adults at ages of 18-55 years in Songzi City showed the immunity against tetanus.


Hu D.-C.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

Objective: To construct a cell strain for stable expression of chimeric antibody against human CD4 and characterize the expressed product. Methods: Plasmid pHDC4 containing anti-CD4 chimeric antibody gene was transfected into CHO-DHFR cells in mediation of liposome, based on which the cell strain for stable expression of anti-CD4 chimeric antibody was screened by selective culture, limiting dilution cloning and MTX pressure screening, then cultured in a large scale by cell factory. The culture supernatant was collected, from which the target antibody was purified by protein A affinity chromatography determined for expression by laser confocal microscopy, and characterized by mass spectrometry, N-terminal amino acid sequencing and determination of equilibrium dissociation constant(KD). Results: The expression level of anti-CD4 chimeric antibody in constructed cell strain reached 4.29 ∼ 10.52 μg/ml, which was 12.68 mg/L after large-scale culture as proved by BCA method. Laser confocal microscopy showed that both the constant region from human origin and the variable region from mouse origin were stably expressed in the constructed cell strain. Mass spectrometry indicated that the anti-CD4 chimeric antibody consisted of components from mouse and human origins. The N-terminal amino acid sequence of light chain was completely consistent with that of its parental antibody WuT4. The KD of the chimeric antibody was 2.67 × 10-9 M. Conclusion: The cell strain for stable expression of chimeric antibody against human CD4 was successfully constructed, and the expressed chimeric antibody maintained the antigen binding specificity and affinity of parental antibody WuT4.


Zou G.-R.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

Objective: To evaluate the safety of adsorbed diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) manufactured by Wuhan Institute of Biological Products Co., Ltd (WIBP). Methods: A multicenter, random, double blind and parallel controlled clinical trial was performed on 1 331 healthy infants aged 3-6 months in Chengdu and Xi'an Cities, without history of inoculation with the vaccine or the history of the relevant diseases. The infants were randomly divided into trial and control groups according to a proportion of 2 to 1. The infants in trial group were inoculated with three doses of DTaP manufactured by WIBP, while those in control groups 1 and 2 with DTaP manufactured by Chengdu Institute of Biological Products Co., Ltd. and Tiantan Biological Products Co., Ltd. respectively, each at an interval of one month according to the schedule for primary immunization in EPI. However, the infants in Chengdu City were boosted 16 months after the first dose. The safety of vaccines were observed, based on which the DTaP manufactured by WIBP was observed for adverse reactions by large-scale vaccination in twenty-five cities and counties belonging to seventeen provinces including Hubei and Hunan. Results: No significant differences were observed in the incidences of systemic reactions, fever reactions of or above grade II or local reactions above grade II in trial and control groups after primary immunization (P > 0.05). The expected systemic and local reaction rates after booster immunization showed no significant difference in trial and control groups (P > 0.05). No unexpected adverse events were observed after primary and booster immunizations. The adverse reaction rate of 58 120 infants after inoculation with DTaP manufactured by WIBP was 292.5/100 000. Conclusion: The DTaP manufactured by WIBP showed high safety.


Shen Z.-J.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

Objective: To prepare the virus-like particles (VLPs) of hepatitis A virus (HAV), and lay a foundation of development of HAV VLPs as vaccine. Methods: P1-2A, P2 and P3 genes were amplified from HAV HM175-clone4 by RT-PCR. P1-2A and P3 genes were subcloned into vector FastBacDual, and the constructed recombinant plasmid pFastBacDual-P1-P3 was transformed to E. coli DH10Bac™. The obtained recombinant shuttle plasmid Bacmid-P1-P3 was transfected to sf-9 cells for packaging of recombinant baculovirus. The recombinant baculovirus vAcP1P3 after proliferation was infected to insect cells Tn-5 and cultured for 72 h. The expressed HAV VLPs were determined by in situ IFA, EIA, Western blot and transmission electron microscopy, and purified by ultrafiltration and sucrose density gradient centrifugation. Results: Recombinant expression vector and recombinant shuttle plasmid were constructed correctly as proved by restriction analysis and sequencing. The titers of recombinant baculovirus of passages 2, 3 and 4 were 1.58 × 105, 2.13 × 107 and 3.98 × 107 TCID50/ml respectively. The expression of HAV protein was observed in sf-9 cells 72 h after transfection with vAcP1P3. The expressed HAV antigen in Tn-5 cells transfected with vAcP1P3 mainly existed in precipitate, of which the content was significantly higher than that in wild HAV (P < 0.001). Western blot showed that the VP3 content in HAV VLPs was lower than that in wild baculovirus. VP1 and VP3 fragments, with relative molecular masses of about 30 700 and about 27 700 respectively, were observed in HAV VLPs. VLPs at a mean diameter of about 50 nm were observed by transmission electron microscopy, which were slightly larger than natural HAV particles. Purified HAV protein mainly existed in 40% ∼ 50% sucrose density gradient, indicating formation of VLPs. Conclusion: HAV VLPs were prepared successfully, which laid a foundation of development of novel hepatitis A vaccine.


Wu J.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

Objective: To analyze the sequence of N genes of 19 rabies virus (RABV) strains isolated from Anhui Province, China in 2011 as well as its difference with other representative street strains and vaccine strains. Methods: The brain tissues of 10 dogs biting people and 121 dogs from dog meat market in Huaibei District, Anhui Province were collected, and detected for RABV antigen by direct immunofluorescent assay, then further identified by intracranial inoculation to Kunming suckling mice. The N gene of RABV was amplified by RT-PCR and cloned into vector pMD18-T for sequencing and genetic analysis, and the results were compared with those of other representative street strains and vaccine strains. Results: Of the 131 brain tissue samples of dogs, 19 were positive for RABV. The positive rates of RABV in the dogs biting people and the dogs from dog meat market were 90% and 8.26% respectively. The homologies between nucleotide and deduced amino acid sequences of N gene of the 19 positive strains were 97.5% ∼ 99.7% and 98.7% ∼ 100% respectively. However, the homologies of nucleotide and deduced amino acid sequences of N gene of the 19 strains to those of representative strains for production of vaccines for human use and for animal use were 85.4% ∼ 89.9% and 94.9% ∼ 99.1% respectively. Most of the nucleotide variations were synonymous mutations. The 19 strains were highly aggregated on phylogenetic tree, which belonged to the same branch with the representative street strains isolated in China previously (except HN10) and to the same subgroup as that of CTN-181 strain. Conclusion: Nineteen rabies virus strains were successfully isolated and identified from the brain tissues of dogs biting people and dogs from dog meat market in Anhui Province, which belonged to RABV genotype I and showed regional characteristic. The study is of a certain significance in monitoring the epidemic of RABV in specified regions.


Zou G.-R.,Wuhan Institute of Biological Products Co.
Chinese Journal of Biologicals | Year: 2013

Objective: To observe the immunogenicity and immune persistence of adosorbed diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) manufactured by Wuhan Institute of Biological Products Co., Ltd (WIBP). Methods: A total of 670 mature healthy infants without immunization history of DTaP or history of diphtheria, tetanus and pertussis in Chengdu Region in September 2007 were selected and divided into trial and control groups according to a proportion of 2:1. The infants in trial group were immunized with three doses of DTaP manufactured by WIBP, while those in control group with DTaP by a manufacturer, each at an interval of one month and a dosage of 0.5 ml, and boosted in March 2009. Venous blood samples were collected before and 30-50 d after primary immunization, before and one month, 1, 2 and 3 years after booster immunization, from which sera were separated and determined for the GMTs of pertussis toxin antibody (PT-Ab), filamentous hemagglutinin antibody (FHA-Ab), diphtheria antibody (D-Ab) and tetanus antibody(T-Ab) by ELISA. If the infants were positive for the antibodies before immunization, the 4-fold increasing rate of GMT was calculated. Results: A total of 544 infants, 351 in trial group and 193 in control group, received a full course of primary immunization according to the schedule. After primary immunization, no significant differences were observed in the positive conversion rates of four antibodies or the 4-fold increasing rate of antibody levels in trial and control groups (P > 0.05). However, the GMT of FHA-Ab in trial group was significantly higher than that in control group (P < 0.05). Before booster immunization, the positive conversion rates of four antibodies in trial group showed no significant difference with those in control group (P > 0.05). However, one month after booster immunization, the positive conversion rate of FHA-Ab in trial group was significantly higher than that in control group (P < 0.05). The positive conversion rates and GMTs of four antibodies 1, 2 and 3 years after booster immunization showed no significant differences in trial and control groups (P > 0.05). The GMTs of four antibodies were more than the protective levels one year, while those of PT-Ab and FHA-Ab were less than the protective levels 2 years after booster immunization. However, the GMTs of D-Ab and T-Ab were still more than the protective level 3 years after booster immunization. Conclusion: The DTaP manufactured by WIBP showed good immunogenicity and immune persistence.

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