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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. Source

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. Source

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. Source

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. Source

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. Source

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