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báo cáo hóa học:" A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice"

Tuyển tập các báo cáo nghiên cứu về hóa học được đăng trên tạp chí sinh học quốc tế đề tài : A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice | Journal of Translational Medicine BioMed Central Open Access Methodology A practical approach for the validation of sterility endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice Sabrina Soncin Viviana Lo Cicero Giuseppe Astori Gianni Soldati Mauro Gola Daniel Surder and Tiziano Moccetti Address The Cell Therapy Unit Cardiocentro Ticino Via Tesserete 48 CH-6900 Lugano Switzerland Email Sabrina Soncin - sabrina.soncin@cardiocentro.org Viviana Lo Cicero - viviana.locicero@cardiocentro.org Giuseppe Astori - giuseppe.astori@cardiocentro.org Gianni Soldati - gianni.soldati@cardiocentro.org Mauro Gola - mauro.gola@ldm.ch Daniel Surder - daniel.suerder@cardiocentro.org Tiziano Moccetti - tiziano.moccetti@cardiocentro.org Corresponding author Published 8 September 2009 Received 5 June 2009 _ _-mno - .-70 I lozil z-rn roi 1 -TO Accepted 8 September 2009 Journal of Translational Medicine 2009 7 78 doi 10.1186 1479-5876-7-78 This article is available from http www.translational-medicine.cOm content 7 1 78 2009 Soncin et al licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http creativecommons.org licenses by 2.0 which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Abstract Background Main scope of the EU and FDA regulations is to establish a classification criterion for advanced therapy medicinal products ATMP . Regulations require that ATMPs must be prepared under good manufacturing practice GMP . We have validated a commercial system for the determination of bacterial endotoxins in compliance with EU Pharmacopoeia 2.6.14 the sterility testing in compliance with EU Pharmacopoeia 2.6.1 and a potency assay in an ATMP constituted of mononucleated cells used in cardiac regeneration. Methods For the potency assay cells were placed in the .