Reproducibility of GMP-compliant production of therapeutic stressed peripheral blood mononuclear cell-derived secretomes, a novel class of biological medicinal products
一类新的生物医药产品治疗性应激外周血单核细胞分泌素GMP生产的重复性
作者: Maria LaggnerAlfred GugerellChristiane BachmannHelmut HofbauerVera VorstandlechnerMarcus SeiboldGhazaleh Gouya LechnerAnja PeterbauerSibylle MadlenerSvitlana DemyanetsDirk SorgenfreyTobias OstlerMichael ErbMichael MildnerHendrik Jan Ankersmit
作者单位: 1Division of Thoracic Surgery, Medical University of Vienna, Vienna, Austria
2Aposcience AG, Vienna, Austria
3Independent Consultant, Mainaschaff, Germany
4Austrian Red Cross Blood Transfusion Service of Upper Austria, Linz, Austria
5Molecular Neuro-Oncology, Department of Pediatrics and Adolescent Medicine and Institute of Neurology, Medical University of Vienna, Vienna, Austria
6Comprehensive Cancer Center of the Medical University of Vienna, Vienna, Austria
7Department for Laboratory Medicine at the Medical University of Vienna, Vienna, Austria
8Dr. Regenold GmbH, Badenweiler, Germany
9SYNLAB Analytics and Services Switzerland AG, Birsfelden, Switzerland
10Research Division of Biology and Pathobiology of the Skin, Department of Dermatology, Medical University of Vienna, Vienna, Austria
刊名: Stem Cell Research & Therapy, 2020, Vol.11 (1), pp.1068-1077
来源数据库: Springer Nature Journal
DOI: 10.1186/s13287-019-1524-2
关键词: Regenerative medicineCell-free secretomesParacrine factorsSecretomeGood manufacturing practiceReproducibilityICH criteriaBiological medicinal productsSpecifications
英文摘要: Abstract(#br)Background(#br)The recent concept of secretome-based tissue regeneration has profoundly altered the field of regenerative medicine and offers promising novel therapeutic options. In contrast to medicinal products with a single active substance, cell-derived secretomes comprise pleiotropic bioactive ingredients, representing a major obstacle for reproducible drug product efficacy and warranting patient safety. Good manufacturing practice (GMP)-compliant production guarantees high batch-to-batch consistency and reproducible efficacy of biological medicinal products, but different batches of cellular secretomes produced under GMP have not been compared yet, and suitable quality control parameters have not been established. To this end, we analyzed diverse biological and...
全文获取路径: Springer Nature  (合作)
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影响因子:3.652 (2012)

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