Shanghai CP Guojian Pharmaceutical Co.

Shanghai, China

Shanghai CP Guojian Pharmaceutical Co.

Shanghai, China

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Schiestl M.,Sandoz GmbH | Li J.,Shanghai CP Guojian Pharmaceutical Co. | Abas A.,National University of Malaysia | Gao K.,National Institute for Food and Drug Control NIFDC | And 4 more authors.
Biologicals | Year: 2014

A determination of biosimilarity is based on a thorough characterization and comparison of the quality profiles of a similar biotherapeutic product and its reference biotherapeutic product. Although the general principles on the role of the quality assessment in a biosimilar evaluation are widely understood and agreed, detailed discussions have not been published yet. We try to bridge this gap by presenting a case study exercise based on fictional but realistic data to highlight key principles of an evaluation to determine the degree of similarity at the quality level. The case study comprises three examples for biosimilar monoclonal antibody candidates. The first describes a highly similar quality profile whereas the second and third show greater differences to the reference biotherapeutic product. The aim is to discuss whether the presented examples can be qualified as similar and which additional studies may be helpful in enabling a final assessment. The case study exercise was performed at the WHO implementation workshop for the WHO guidelines on quality assessment of similar biotherapeutic products held in Xiamen, China, in May 2012. The goal was to illustrate the interpretation of the comparative results at the quality level, the role of the quality assessment in the entire biosimilarity exercise and its influence on the clinical evaluation. This paper reflects the outcome of the exercise and discussion from Xiamen. © 2013 The International Alliance for Biological Standardization.


Gao W.,Shanghai CP Guojian Pharmaceutical Co. | Zhang J.,Sanofi S.A. | Xiang J.,Shanghai CP Guojian Pharmaceutical Co. | Zhang L.,Shanghai CP Guojian Pharmaceutical Co. | And 4 more authors.
Current Cancer Drug Targets | Year: 2016

Antibody-drug conjugates (ADCs) take the advantage of antigen specificity of monoclonal antibodies to deliver highly potent cytotoxic drugs selectively to antigen-expressing tumor cells. The recent approval of Adcetris™ and Kadcyla™ as well as emerging data from numerous ongoing clinical trials underscore the role of ADCs as a new therapeutic option for cancer patients. However, conventional conjugation methods generally result in a heterogeneous mixture of ADCs, which can result in significant therapeutic liabilities and can lead to complicated manufacturing processes. The increased understanding from the clinical investigation of current ADCs and site-specific bioconjugation technologies has enabled scientists to accelerate the discovery and development of the next generation ADCs with defined and homogeneous composition. The present manuscript reviews the recent advances and trends in the research and development of novel ADCs obtained by site-specific conjugation method. © 2016 Bentham Science Publishers.


PubMed | World Health Organization, Food Republic, Health Products Regulation Group HPRG, Pfizer and 5 more.
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2014

A determination of biosimilarity is based on a thorough characterization and comparison of the quality profiles of a similar biotherapeutic product and its reference biotherapeutic product. Although the general principles on the role of the quality assessment in a biosimilar evaluation are widely understood and agreed, detailed discussions have not been published yet. We try to bridge this gap by presenting a case study exercise based on fictional but realistic data to highlight key principles of an evaluation to determine the degree of similarity at the quality level. The case study comprises three examples for biosimilar monoclonal antibody candidates. The first describes a highly similar quality profile whereas the second and third show greater differences to the reference biotherapeutic product. The aim is to discuss whether the presented examples can be qualified as similar and which additional studies may be helpful in enabling a final assessment. The case study exercise was performed at the WHO implementation workshop for the WHO guidelines on quality assessment of similar biotherapeutic products held in Xiamen, China, in May 2012. The goal was to illustrate the interpretation of the comparative results at the quality level, the role of the quality assessment in the entire biosimilarity exercise and its influence on the clinical evaluation. This paper reflects the outcome of the exercise and discussion from Xiamen.


Ma Y.,Shanghai CP Guojian Pharmaceutical Co. | Lin B.-R.,Shanghai CP Guojian Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2013

In this article, we reviewed the clinical pharmacokinetic characteristics of etanercept. The results demonstrated that etanercept and its biosimilars showed similar clinical pharmacokinetic characteristics. There were no significant differences among healthy volunteers and patients of different indications. In patients with renal disease and heart failure, the elimination of etanercept was not affected by the disease. Combination with DMARDs such as methotrexate could not affect its pharmacokinetic characteristics. Weight, body surface area and age (<17) were the important factors that could influence etanercept's distribution and elimination. However, the impact of gender seemed to be insignificant.


Cai C.,Shanghai Ocean University | Wang Y.,Shanghai University of Traditional Chinese Medicine | Li C.,Shanghai CP Guojian Pharmaceutical Co. | Guo Z.,Shanghai Ocean University | And 4 more authors.
Journal of Ocean University of China | Year: 2014

Phycoerythrin and phycocyanin were purified from Porphyra yezoensis Ueda with their bioactivity determined in this study. Continuous precipitation with ammonium sulfate at different concentrations (10%, 20%, 40% and 50%) increased the purity (A564:A280) of phycoerythrin to 1.49, 3.92 fold of the raw extract (0.38) and the purity (A615:A280) of phycocyanin to 0.70, 3.33 fold of the raw extract (0.21). Two more times of chromatography with hydroxylapatites finally made the purity of phycoerythrin and phycocyanin reach 5.50, 14.47 fold of the raw extract, and 5.10, 24.29 fold of the raw extract, respectviely. The yield of high purity phycoerythrin and phycocyanin were 0.21% and 0.09% of dried P. yezoensis blade, respectively. The photodynamic cytotoxic experiment showed that both phycoerythrin and phycocyanin inhibited the growth of liver tumor cells significantly. It was found that 250 mg L-1 purified phycoerythrin and phycocyanin inhibited the growth of hepatocellular carcinoma cells 24 h after laser-irradiation by 80% and 59%, respectively, and 100 mg L-1 purified phycoerythrin and phycocyanin induced the apoptosis of 31.54% and 32.54% of the cells, respectively, 8 h after photodynamic therapy. Oue findings demonstrated that P. yezoensis can serve as photosensitizer (phycoerythrin and phycocyanin) producer. © 2014 Science Press, Ocean University of China and Springer-Verlag Berlin Heidelberg.


Wang T.,Shanghai CP Guojian Pharmaceutical Co. | Ma Y.,Shanghai CP Guojian Pharmaceutical Co. | Ma Y.-M.,Shanghai CP Guojian Pharmaceutical Co. | Lin B.-R.,Shanghai CP Guojian Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2015

Relapsed and refractory B-cell precursor acute lymphoblastic leukemia has a dismal prognosis. Currently, drugs approved for the treatment of similar diseases were very limted. The US FDA had approved blinatumomab (Blincyto™, AMG103) for the treatment of Philadelphia chromosome-negative relapsed and refractory B-cell precursor acute lymphoblastic leukemia through the accelerated approval program. Blinatumomab is a kind of tumor immunotherapeutic drugs, which has been developed based on bispecific T cell engager system owned by Amgen Inc. Blinatumomab is a bispecific antibody that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It activates endogenous T cells, and then the cytotoxic T cells recognize and kill the malignant B cells. In this article we summarized the pharmacology, pharmacokinetics, clinical efficacy and safety profile of blinatumomab. © 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved.


Ma Y.,Shanghai CP Guojian Pharmaceutical Co. | Wang T.,Shanghai CP Guojian Pharmaceutical Co. | Ma Y.-M.,Shanghai CP Guojian Pharmaceutical Co. | Lin B.-R.,Shanghai CP Guojian Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2014

Ramucirumab is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody developed by Eli Lilly. Ramucirumab can specifically bind to human vascular endothelial growth factor receptor 2 (VEGFR2) and effectively prevent the interaction between VEGFR2 and its ligands (including VEGF-A, VEGF-C and VEGF-D). The blockade of VEGFR2 can inhibit the activation of VEGFR2 and downstream signaling transduction. Its indication for the treatment of patients with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy has been approved by FDA on April 2014. This article summarized the pharmacology, pharmacokinetics, clinical efficacy and safety profiles of ramucirumab.


Wang G.-H.,Shanghai CP Guojian Pharmaceutical Co.
Chinese Journal of Biologicals | Year: 2011

Objective: To develop a procedure for purification of immunotoxin ScFv(anti HER2)-PE38. Methods: Immunotoxin ScFv (anti HER2)-PE38 was de-naturalized, then re-naturalized and purified by metal chelate column chromatography, and further purified by molecular sieve chromatography. The purified product was analyzed by SDS-PAGE. Results: The immunotoxin ScFv (anti HER2)-PE38 in a form of inclusion body was effectively dissolved with 8 mol / L urea. The optimal gradient of diluent, time and flow rate for renaturation were 0-100%, 150 min and 2 ml/min respectively. The purity of target protein after renaturation reached more than 95%. The molecular sieve chromatography with Superdex 200 showed satisfactory effect, by which the purity of purified product reached more than 98%. Conclusion: A procedure for purification of immunotoxin ScFv (anti HER2)-PE38 was developed, which laid a foundation of further study.


Lacy S.E.,AbbVie Bioresearch Center | Wu C.,Shanghai CP Guojian Pharmaceutical Co. | Ambrosi D.J.,AbbVie Bioresearch Center | Hsieh C.-M.,AbbVie Bioresearch Center | And 7 more authors.
mAbs | Year: 2015

Interleukin-1 (IL-1) cytokines such as IL-1α, IL-1β, and IL-1Ra contribute to immune regulation and inflammatory processes by exerting a wide range of cellular responses, including expression of cytokines and chemokines, matrix metalloproteinases, and nitric oxide synthetase. IL-1α and IL-1β bind to IL-1R1 complexed to the IL-1 receptor accessory protein and induce similar physiological effects. Preclinical and clinical studies provide significant evidence for the role of IL-1 in the pathogenesis of osteoarthritis (OA), including cartilage degradation, bone sclerosis, and synovial proliferation. Here, we describe the generation and characterization of ABT-981, a dual variable domain immunoglobulin (DVD-Ig) of the IgG1/k subtype that specifically and potently neutralizes IL-1a and IL-1b. In ABT-981, the IL-1β variable domain resides in the outer domain of the DVD-Ig, whereas the IL-1a variable domain is located in the inner position. ABT-981 specifically binds to IL-1α and IL-1β, and is physically capable of binding 2 human IL-1α and 2 human IL-1β molecules simultaneously. Single-dose intravenous and subcutaneous pharmacokinetics studies indicate that ABT-981 has a half-life of 8.0 to 10.4 d in cynomolgus monkey and 10.0 to 20.3 d in rodents. ABT-981 exhibits suitable drug-like-properties including affinity, potency, specificity, half-life, and stability for evaluation in human clinical trials. ABT-981 offers an exciting new approach for the treatment of OA, potentially addressing both disease modification and symptom relief as a disease-modifying OA drug. © 2015, AbbVie Inc.


Patent
Shanghai CP Guojian Pharmaceutical Co. | Date: 2011-07-20

This invention discloses a kind of concentrated medium for large-scale culture of Chinese Hamster Ovary cell. The said medium comprises basic medium and high dose additives. This invention also discloses the method of adding the described concentrated medium in large-scale fed-batch culture of CHO cells.

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