{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,25]],"date-time":"2023-09-25T05:49:18Z","timestamp":1695620958782},"reference-count":17,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T00:00:00Z","timestamp":1436832000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Darioush Shirvani and Stefanie Nagel as well as Curt Carste (Terumo BCT)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>In several European countries, preparation of cellular products with open manufacturing systems as used for cryopreservation of peripheral blood stem cells (PBSCs) needs to be performed in a clean\u2010room facility. However, this form of manufacturing is highly expensive and laborious. Thus, safe techniques providing improved efficacy regarding time and material, which are in accordance with legal requirements are highly desirable.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>We have developed, validated, and applied a simple method for cryopreservation of PBSCs within a functionally closed\u2010bag system using the closed cryo freeze prep set. This process fulfills good manufacturing practice requirements and allows for the cryopreservation of PBSCs without a clean\u2010room facility. In addition to cryopreservation of PBSCs, we have recently successfully modified our system for processing, portioning, and cryopreservation of allogeneic donor lymphocytes.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Since 2010, cryopreservation of PBSCs using a closed\u2010bag system has been performed in our facility on a routine basis and 210 patients and healthy donors have been included in this analysis. No significant reduction in viability of CD34+ cells and no process\u2010related contamination were observed. Outcome of hematopoietic stem cell transplantation regarding time of engraftment and infectious complications is comparable to products manufactured in conventional clean\u2010room facilities.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>Our data confirm that cryopreservation of PBSCs within a functionally closed\u2010bag system is safe, effective, and economical. Furthermore, the system has the potential to be extended to other manufacturing processes of cellular products.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.13206","type":"journal-article","created":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T12:47:49Z","timestamp":1436878069000},"page":"2702-2708","source":"Crossref","is-referenced-by-count":3,"title":["Long\u2010term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed\u2010bag system: a technology with potential for broader application"],"prefix":"10.1111","volume":"55","author":[{"given":"Silvia","family":"Spoerl","sequence":"first","affiliation":[{"name":"Medizinische Klinik III, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Peter","sequence":"additional","affiliation":[{"name":"Medizinische Klinik III, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dagmar","family":"W\u00e4scher","sequence":"additional","affiliation":[{"name":"Medizinische Klinik III, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mareike","family":"Verbeek","sequence":"additional","affiliation":[{"name":"Medizinische Klinik III, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helge","family":"Menzel","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology St Franziskus\u2010Hospital, Malteser Norddeutschland Flensburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Peschel","sequence":"additional","affiliation":[{"name":"Medizinische Klinik III, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela M.","family":"Krackhardt","sequence":"additional","affiliation":[{"name":"Medizinische Klinik III, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,7,14]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"L 159\/46","article-title":"Commission Directive 2003\/63\/EC","author":"The Commission of the European Communities","year":"2003","journal-title":"Official Journal of the European Union 27.6"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2002.00013.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2003.00573.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2007.01232.x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2013.01.017"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12012"},{"key":"e_1_2_8_8_1","doi-asserted-by":"crossref","first-page":"5124","DOI":"10.4049\/jimmunol.150.11.5124","article-title":"Impairment of function in aging neutrophils is associated with apoptosis","volume":"150","author":"Whyte MK","year":"1993","journal-title":"J Immunol"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.4204"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-09-3869"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa065464"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2009-03-208355"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V91.9.3148"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/tid.12225"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1086\/514956"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03359.x"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2005.04178.x"},{"key":"e_1_2_8_18_1","unstructured":"Europ\u00e4isches Arzneibuch 6. 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