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Utility of routine evaluation of sterility of cellular therapy products with or without extensive manipulation: Best practices and clinical significance

机译:常规评估细胞治疗产品无菌性的效用,无论是否有广泛的操纵:最佳实践和临床意义

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摘要

Graphical AbstractHighlights?Routine sterility testing improves best practices in the HSCT setting.?Contamination of stem cell products has no significant impact on the outcome of HSCT.?Use of antibiotics in media for expansion of ATMPs is advisable.?Costs of sterility testing of ATMPs is high when performed in GMP-approved laboratory.AbstractBackgroundWe analyzed the results of routine sterility testing performed in our center over the last 10 years, in the context both hematopoietic stem cell transplantation (HSCT) and Advanced Therapeutic Medicinal Products (ATMPs).
机译:<![cdata [ 图形抽象 亮点 常规无菌测试改善了HSCT设置中的最佳实践。 干细胞产品的污染对结果没有显着影响HSCT。 建议用于扩展ATMP的媒体中的抗生素。 < CE:标签>? 在GMP批准的实验室进行时,ATMPS的无菌测试的成本很高。 抽象 背景 我们分析了过去10年在我们的中心在我们的中心进行的常规无菌测试的结果,在上下文中,造血干细胞移植(HSCT)和先进的治疗药物产品(ATMPS)。

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  • 来源
    《Cytotherapy》 |2018年第2期|共9页
  • 作者单位

    Centre of Cellular Therapy “G. Lanzani” Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Centre of Cellular Therapy “G. Lanzani” Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Centre of Cellular Therapy “G. Lanzani” Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Centre of Cellular Therapy “G. Lanzani” Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Haematology and Bone Marrow Transplant Unit Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Haematology and Bone Marrow Transplant Unit Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Microbiology &

    Virology Laboratory Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Microbiology &

    Virology Laboratory Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Microbiology &

    Virology Laboratory Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Haematology and Bone Marrow Transplant Unit Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

    Centre of Cellular Therapy “G. Lanzani” Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 细胞工程;
  • 关键词

    advanced therapeutic medicinal products; cost analysis; hematopoietic stem cell transplantation; microbial contamination;

    机译:先进的治疗药品;成本分析;造血干细胞移植;微生物污染;

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