Chengdu Rongsheng Pharmaceuticals Co.

Chengdu, China

Chengdu Rongsheng Pharmaceuticals Co.

Chengdu, China
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Liang H.,Chengdu Rongsheng Pharmaceuticals Co. | Fei B.,Chengdu Rongsheng Pharmaceuticals Co. | Shen H.,Chengdu Rongsheng Pharmaceuticals Co. | Lei T.,Chengdu Rongsheng Pharmaceuticals Co. | And 4 more authors.
Biomedical Research (India) | Year: 2017

Factor IX is a vitamin K-dependent coagulation factor which undergoes several post-translational modifications for its proper function. We established the Chinese hamster ovary cells expressing the recombinant human coagulation factor IX (rhFIX). In order to maximize the expression of rhFIX in serum-free suspension culture, we evaluated the effect of several metal ion concentrations including Ca2+ and Mg2+ in the cell serum-free culture medium. A high production FIX CHO cell line was screened and the highest clotting activity was obtained in 2 mM Ca2+, combined with 1 mM Mg2+ showed an excellent improvement compared with culture without any metal ion addition, the peak FIX activity was 1.36 IU/ml compared with 0.62 IU/ml. It means a higher level of fermentation process and the CHO cell line is a promising alternative for recombinant FIX manufacturing. © 2017, Scientific Publishers of India. All rights reserved.

Huang W.,National Institutes for Food and Drug Control | Song A.,National Institutes for Food and Drug Control | Qiao S.,Beijing Wantai Biological Pharmacy Co. | Zhao C.,National Institutes for Food and Drug Control | And 3 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2016

Objective: To analyze the practicability of using ELISA kit for the detection of hepatitis E virus antigen (HEV-Ag) in plasma donations and Biomex HEV seroconversion panels. Methods: The HEV-Ag positive samples were screened out from 36 340 donated blood plasma samples. Real-time fluorescent PCR was performed for the detection of HEV RNA in HEV-Ag positive samples. The open reading frame 2 (ORF2) in HEV RNA was amplified by nested RT-PCR and the amplified products were confirmed by sequencing analysis. Phylogenetic tree was constructed for HEV genotyping. Five Biomex HEV seroconversion panels were used in this study for the detection of HEV-Ag, anti-HEV antibody and HEV RNA as well as the correlation analysis between HEV-Ag and HEV RNA. Results: Twenty-six out of 36 340 plasma samples (0.07%) were positive for HEV-Ag. Of the 26 samples, 25 samples were positive for HEV RNA as indicated by the results of nested RT-PCR and 23 positive samples were confirmed by sequencing analysis. The positive rate of HEV RNA in blood plasma donators was 1 : 1 580 (0.06%). There were 17 samples of genotype 1 (74%) and 6 samples of genotype 4 (26%) according to the phylogenetic tree analysis. All of the HEV-Ag positive samples were also positive for HEV RNA as indicated by the analysis of Biomex seroconversion panels. HEV-Ag was consistent with the peak of the HEV RNA concentration. Conclusion: A close relationship between HEV-Ag and HEV RNA was observed. HEV-Ag screening could be used as a measure to reduce the risk of HEV transmission by blood transfusion. Copyright © 2016 by the Chinese Medical Association.

Sun X.,Sichuan Agricultural University | Lei T.,Chengdu Rongsheng Pharmaceuticals Co. | Du J.-B.,Sichuan Agricultural University | Yang W.-Y.,Sichuan Agricultural University
International Journal of Agriculture and Biology | Year: 2015

Plastid terminal oxidase (PTOX) is a plastoquinol oxidase, which plays several important roles in plants. Previous studies suggested that PTOX is encoded by a single gene with only one copy in higher plants. Here we report the identification of two possible paralogous PTOX genes on different chromosomes of soybean, both of which are highly homologous to known PTOX genes in other species. These two paralogs have quite different introns and nearly the same exons and were predicted to encode membrane protein with chloroplast transit peptide. The deduced PTOX protein encoded by both paralogs were proposed to be functional, since the existence of highly conserved amino acid sites necessary for a typical PTOX, including six iron-binding sites and Exon 8 domain. Moreover, soybean PTOX also exhibit clear sequence similarity to alternative oxidase (AOX). Organ-specific expression analysis showed high transcript levels of soybean PTOX in stems, leaves and flowers, while the levels in pods and roots were relatively low. In addition, a light-inducible character was also suggested for soybean PTOX in the present study. © 2015 Friends Science Publishers.

Zhang W.,Peking Union Medical College | Ke L.,Peking Union Medical College | Changqing L.,Peking Union Medical College | Zhang Y.,Cheng Du Rongsheng Pharmaceuticals Co. | Li W.,Peking Union Medical College
Journal of Translational Medicine | Year: 2012

Background: To ensure the safety of plasma derivatives, screening for human parvovirus B19V genomic DNA in donated plasma using a pooling strategy is performed in some countries. We investigated the prevalence of B19V DNA and anti-B19V antibodies in Chinese plasma pools, plasma derivatives and plasma donations to evaluate the risk posed by B19V.Methods: Using a Q-PCR assay developed in-house, we tested for B19V genomic DNA in 142 plasma pools collected between January 2009 and June 2011 from two Chinese blood products manufacturers. Plasma derivatives collected between 1993-1995 (10 batches of albumin, 155 batches of intravenous immunoglobulin, IVIG) and 2009-2011 (50 batches of albumin, 54 batches of IVIG, 35 batches of factor VIII, 7 batches of fibrinogen, and 17 batches of prothrombin complex concentrate, PCC) were also tested for B19V contamination. In addition, B19V genome prevalence in minipools(including 90 individual donations) of 49680 individual plasma samples collected between August 2011 and March 2012 by a single Chinese manufacturer was investigated. IgM/IgG was also investigated in plasma pools/derivatives and in minipools with B19V-DNA titers above 1x104 and 1x106 geq/mL using B19 ELISA IgM/IgG assay(Virion-Serion, Würzburg, Germany), respectively.Results: B19V-DNA was detected in 54.2% of plasma pools from two Chinese blood product manufacturers; among recently produced blood products, B19V was detected in 21/54 IVIG samples, 19/35 factor VIII samples, 6/7 fibrinogen samples, and 12/17 PCC samples, but not in albumin samples. The levels of B19V-DNA in these samples varied from 102-107 geq/mL. In samples with >104 geq/mL genome DNA, B19V-specific IgG was also found in all corresponding plasma pools and IVIG, whereas none was detected in the majority of other plasma derivatives. Screening of plasma donations indicated that most minipools were contaminated with B19V-DNA (102-108 geq/mL) and one donation had 1.09 × 1010 geq/mL B19V genomic DNA along with a non-classical IgG/IgM profile.Conclusions: Despite the implementation of some inactivation/removal methods designed to prevent viral contamination, B19V DNA was detectable in Chinese plasma pools and plasma derivatives. Thus, the introduction of B19V screening and discard donation with high viramic concentration for Chinese plasma donors would be desirable. © 2012 Zhang et al.; licensee BioMed Central Ltd.

Wang J.-Y.,University of Sichuan | Wang J.-Y.,Chengdu Rongsheng Pharmaceuticals Co. | Yu H.-R.,University of Sichuan | Xie R.,University of Sichuan | And 4 more authors.
AIChE Journal | Year: 2013

A novel type of core-shell capsules with ultrathin alginate/protamine/silica (APSi) hybrid membranes are successfully fabricated through a coextrusion minifluidic approach and a biosilicification method for immobilization of laccase. The ultrathin membranes were beneficial to the mass transfer across the capsule membranes, and the silica layer on the outer surface was efficient to inhibit the swelling of the capsule membranes. The immobilizing yield was considered to be 100% because all the enzyme molecules were encapsulated inside the capsules through the proposed method, and the laccase activity immobilized in APSi capsules was 61.8 mmol·g-1·min-1. The thermal, pH and storage stabilities of the immobilized laccase in APSi capsules were determined in comparison with free laccase. The stability of encapsulated laccase was significantly improved, which was as high as 67% after 20 days. The residual relative activity of encapsulated laccase remained 45% after 10 cycles. © 2012 American Institute of Chemical Engineers (AIChE).

He T.-P.,Chengdu Rongsheng Pharmaceuticals Co. | Tang J.-Y.,Chengdu Rongsheng Pharmaceuticals Co. | Xu L.,Chengdu Rongsheng Pharmaceuticals Co. | Song C.-L.,Chengdu Rongsheng Pharmaceuticals Co. | And 4 more authors.
Chinese Journal of Biologicals | Year: 2011

Objective: To express recombinant human follicle-stimulating hormone (FSH) in CHO cells. Methods: Recombinant plasmid pcDNA5 / dhfr / FSH containing the α and β subunits of FSH linked at gene level with internal ribosome entry site (IRES) sequence was constructed under the control of a single CMV promoter and transfected to CHO cells, based on which a recombinant CHO cell strain for stable expression was screened and analyzed for growth and expression of target protein. Results: Restriction analysis and sequencing proved that recombinant plasmid pcDNA5 / dhfr / FSH was constructed correctly, with which the positive cloning rate of transfected CHO cells was 80.65%. A recombinant CHO cell strain D5 was obtained by MTX pressure and cloning screening. The expression level of FSH in D5 cell strain in serum-free fed-batch culture in shake-flask was 2.5 IU / ml, which increased by more than 2 times and reached 6 IU / ml in bioreactor with controllable culture parameters. Conclusion: A method for expression of heterodimeric glycoprotein in CHO cells was developed. The obtained recombinant CHO cells were suitable for serum-free and large-scale cultures, with which the target protein was highly expressed in bioreactor, and the expression level might be further increased by optimization of culture condition.

Zheng F.-P.,Chengdu Rongsheng Pharmaceuticals Co. | Wang B.,Chengdu Rongsheng Pharmaceuticals Co. | Zheng Q.,Chengdu Rongsheng Pharmaceuticals Co. | Lv J.-C.,Chengdu Rongsheng Pharmaceuticals Co.
Chinese Journal of Biologicals | Year: 2012

Objective: To analyze the influencing factors of velocity during removal of virus in human immunoglobulin for intravenous injection(IVIG) by DV50 nanofiltration. Methods: The turbidity and concentration of bulk of IVIG were determined by turbidimeter and densimeter respectively. Five batches of bulks with similar concentrations and different turbidities, as well as five batches of bulks with similar turbidities and different concentrations, were subjected to nanofiltration by using the filter elements of the same batch, and the mean velocity was calculated. Another five batches of bulks with similar turbidities and concentrations were subjected to nanofiltration by using the filter elements of different batches, and the mean velocity was calculated. Results: The mean velocity decreased with the increasing turbidity of bulk, while showed no linear relationship to the concentration. The mean velocity of nanofil-tration by using various filter elements showed significant difference. Conclusion: The turbidity of product showed a certain influ-ence, while the concentration showed no significant difference, on velocity. However, the filter element showed significant influence on velocity. The study provided a reference to controlling the velocity during removal of virus by nanofiltration and improving the pro-duction procedure of IVIG.

Yu W.,Chengdu Rongsheng Pharmaceuticals Co. | Mu L.,Chengdu Rongsheng Pharmaceuticals Co. | Lu T.,Chengdu Rongsheng Pharmaceuticals Co. | Li W.,Chengdu Rongsheng Pharmaceuticals Co. | Wang Q.-C.,Chengdu Rongsheng Pharmaceuticals Co.
Chinese Journal of Biologicals | Year: 2015

Objective To compare the human coagulation factor VIII (FVIII) prepared by glycine/sodium chloride precipitation (salting out) and by chromatography. Methods The intermediate sample and final product of FVIII prepared by the two processes were determined the protein content by Biuret method, and for coagulation activity by ACL7000 analyzer, based on which the specific activity was calculated. The residual Tween-80 and TNBP contents, appearance, visual foreign matters, moisture, pyrogen and abnormal toxicity were tested according to the requirements in Chinese Pharmacopeia (Volume VIII, 2010 edition). Results During chromatographic the purification process, the preparation of cryoprecipitate from fresh frozen plasma guaranteed the yield of F VIII, while PEG precipitation decreased the operation volume. Chromatography effectively removed the foreign protein and increased the specific activity of F VIII by at least 25 folds. Neither S/D treatment nor virus inactivation at 80°C for 72 h showed significant effect on the quality of F VIII. Conclusion The specific activity as well as residual Tween-80 and TNBP contents of F VIII prepared by chromatography were superior to those by glycine/sodium chloride, indicating that the chromatographic process was more suitable for the large-scale production of F VIII.

Ye X.-S.,Chengdu Rongsheng Pharmaceuticals Co. | Fu D.-X.,Chengdu Rongsheng Pharmaceuticals Co. | Duan Y.,Chengdu Rongsheng Pharmaceuticals Co. | Zhang S.-L.,Chengdu Rongsheng Pharmaceuticals Co. | And 2 more authors.
Chinese Journal of Biologicals | Year: 2015

Objective To analyze the prevalence of hepatitis E virus (HEV) infection in plasma donors and blood products in 2014. Methods The plasma samples of donors from various provinces (Sichuan, Shandong and Shanxi) were determined for HEV Ag, HEV IgM and HEV IgG by ELISA, of which the positive ones were traced. The final product and pooled plasma were determined for HEV Ag. Results Of the 36 340 samples, 26(0.07%) were positive for HEV Ag. However, of the 3 780 samples, 1 519 (40.19%) were positive for HEV IgG, and 34 (0.90%) for HEV IgM. All the 113 batches of final products and 115 batches of pooled plasma samples were negative for HEV Ag. Conclusion The HEV positive rates in plasma of donors in various areas showed significant difference. However, the prepared blood products showed high safety.

Lu T.,Chengdu Rongsheng Pharmaceuticals Co. | Mu L.,Chengdu Rongsheng Pharmaceuticals Co. | Liu B.,Chengdu Rongsheng Pharmaceuticals Co. | Wang Y.,Chengdu Rongsheng Pharmaceuticals Co.
Chinese Journal of Biologicals | Year: 2015

Objective To prepare and identify a novel intravenous immunoglobulin (IVIG). Methods Eight batches of 10% IVIG were prepared by ultrafiltration. Glycine was used as a stabilizer instead of sugar, of which the concentration was optimized (12 ∼ 18 g/L). The 10% IVIG was tested for overall quality, IgG subclass distribution, Fc activity and stability. Results The optimal concentration of glycine was 15 g/L. The overall quality of 10% IVIG met the relevant requirements, while the IgG subclass distribution, Fc activity and stability were similar to those of 5% IVIG. The overall quality of 10% IVIG met the relevant requirements after storage at 25°c for 6 months and at 2 ∼ 8°C for 6 years. Conclusion The 10% IVIG showed good quality and stability.

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