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Study on Methods and Requirements for Quality Control ofRecombinant Human Tumor Necrosis Factor RelatedApoptosis Inducing Ligand(rhTRAIL)

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To establish methods and requirements for quality control of recombinant human tumor necrosis factor related apoptosis inducing ligand(rhTRAIL).Method:Biological potency of rhTRAIL was determined by NCI-H460 cell cytotoxity assay.relative molecular mass of rhTRAIL was detected by reducing SDS-PAGE.Purity of rhTRAIL was analyzed by SDS-PAGE and RP-HPLC.Isoelectric point and peptide mapping were detected separately by CE and tryptic digestion.Routine tests were all carried out accordingly to the National Requirements for Biological Products.Results:The requirements and methods for quality control of rhTRAIL had been established and used for quality control of bulk and final product.The results of all tests complied with the requirements of quality control of rhTRAIL.Conclusion:The methods and requirements for quality control of rhTRAIL showed advantages of assuring the products safety and efficacy,which can be used for routine quality control of rhTRAIL.

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Keywords: bioassay; quality control; recombinant human tumor necrosis factor related apoptosis inducing ligand

Document Type: Research Article

Publication date: 01 March 2005

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  • Journal of Pharmaceutical Analysis is a professional journal administrated by China Association for Science and Technology, sponsored by Chinese Pharmaceutical Association, held by National Institutes for Food and Drug Control, edited and published by the Editorial Board of Journal of Pharmaceutical Analysis, and publicly distributed at home and abroad. It is one of the first group of journals that created by academic leaders in the field of drug control. It originated from Drug Control Communication which magazine was founded in 1951 and later been renamed in 1981. In 2005, it was changed from bi-monthly journal to monthly journal. Journal of Pharmaceutical Analysis is among core journals in nature sciences and even other Chinese core journals, whose main columns are research reports, communications, review, forum, information and etc. It mainly reports the latest research results, explore new theories, introduce new development, spread new techniques, and promote new methods of pharmaceutical analysis. Its contents include peer-reviewed research reports, research presentation and summary reviews on all aspects of pharmaceutical analysis including drug development, pharmaceutical manufacturing, clinical research, drug safety, quality assessment, and market surveillance. Main authors and target reader are professional and technical personnel engaged in research, application as well as higher education in pharmaceutical analysis.
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