CryoMACS冷冻袋与Maco Biotech冷冻-醋酸乙烯基醋酸乙烯袋对造血祖细胞冷冻保存的比较

IF 1.2 4区 生物学 Q4 CELL BIOLOGY
Biopreservation and Biobanking Pub Date : 2020-10-01 Epub Date: 2020-08-18 DOI:10.1089/bio.2019.0135
Valentina Becherucci, Silvia Bisin, Stefano Ermini, Luisa Piccini, Valentina Gori, Francesca Gentile, Riccardo Ceccantini, Elena De Rienzo, Barbara Bindi, Paola Pavan, Vanessa Cunial, Elisa Allegro, Francesca Brugnolo, Franco Bambi
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引用次数: 1

摘要

背景:造血祖细胞(HPCs)冷冻保存具有应用价值,特别是在自体环境中,可以在收集后数年用于治疗。低温保存的目的是保存造血干细胞的治疗特性,成功的低温保存取决于几个因素,如保存程序、生物保存介质、冷冻速率和解冻程序。在这种情况下,冷冻袋的选择是至关重要的,因为它在冷冻过程中提供机械保护。由于澳门生物科技冷冻醋酸乙烯基(EVA)袋®在我国已不再供应,因此我们开展了一项比较研究,以验证与Miltenyi CryoMACS®冷冻袋的生物等效性。方法:本研究采用CD34+富集产物制备HPC单采。冷冻袋内填满相同体积,控制速率冷冻,在液氮气相中保存至少6个月。解冻后,使用微生物挑战测试所有袋子的完整性和无菌性。此外,还通过评估白细胞、单核细胞、淋巴细胞和CD34+细胞的恢复情况进行了比较。结果:两种厂家的包装袋在评价参数方面无显著差异。数据得到确认,甚至根据填充量比较袋子。本研究的数据支持CryoMACS冷冻袋与Maco Biotech冷冻eva袋在HPC冷冻保存方面具有生物等效性的结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of CryoMACS Freezing Bags with Maco Biotech Freezing-Ethinyl Vinyl Acetate Bags for Hematopoietic Progenitor Cells Cryopreservation Using a CD34+-Enriched Product.

Background: Hematopoietic progenitor cells (HPCs) cryopreservation have applications, especially in the autologous setting, allowing therapeutic use several years after collection. Cryopreservation aims to preserve the therapeutic properties of HPCs, and successful cryopreservation depends on several factors such as preservation procedures, biopreservation media, freezing rates, and thawing procedures. In this context, the choice of the freezing bag is critical as it provides mechanical protection during the freezing process. Since Maco Biotech Freezing-ethinyl vinyl acetate (EVA) Bags® are no longer available in our country, a comparative study was developed to verify bioequivalence with the Miltenyi CryoMACS® freezing bag. Methods: In this study, a CD34+-enriched product was used to better reproduce HPC apheresis. Freezing bags were filled with the same volume, cryopreserved with controlled rate freezing, and stored in the vapor phase of liquid nitrogen for at least 6 months. After thawing, all bags were tested for integrity and sterility using a microbial challenge. In addition, a comparison was developed by evaluating recovery of white blood cells, mononuclear cells, lymphocytes, and CD34+ cells. Results: No significant differences between the two manufacturers' bags have been observed in terms of the evaluated parameters. Data were confirmed, even comparing bags according to filling volume. Data presented in this study support the conclusion that CryoMACS freezing bags are bioequivalent to Maco Biotech Freezing-EVA Bags for HPC cryopreservation.

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来源期刊
Biopreservation and Biobanking
Biopreservation and Biobanking CELL BIOLOGY-MEDICAL LABORATORY TECHNOLOGY
CiteScore
3.30
自引率
12.50%
发文量
114
审稿时长
6-12 weeks
期刊介绍: Biopreservation and Biobanking is the first journal to provide a unifying forum for the peer-reviewed communication of recent advances in the emerging and evolving field of biospecimen procurement, processing, preservation and banking, distribution, and use. The Journal publishes a range of original articles focusing on current challenges and problems in biopreservation, and advances in methods to address these issues related to the processing of macromolecules, cells, and tissues for research. In a new section dedicated to Emerging Markets and Technologies, the Journal highlights the emergence of new markets and technologies that are either adopting or disrupting the biobank framework as they imprint on society. The solutions presented here are anticipated to help drive innovation within the biobank community. Biopreservation and Biobanking also explores the ethical, legal, and societal considerations surrounding biobanking and biorepository operation. Ideas and practical solutions relevant to improved quality, efficiency, and sustainability of repositories, and relating to their management, operation and oversight are discussed as well.
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