Packaging Considerations for Biopreservation.
Packaging Considerations for Biopreservation.
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生物保存的包装注意事项。
DOI：
10.1159/000326083
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发表时间：
2011
期刊：
影响因子：
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通讯作者：
Thirumala,Sreedhar
中科院分区：
文献类型：
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作者：
Woods,ErikJ;Thirumala,Sreedhar
出于多种原因，选择用于生物保存的包装系统至关重要。理想的生物保存容器系统必须提供封闭完整性、样品稳定性和容易获得保存的材料。这意味着系统需要密封，以确保在整个处理、储存和分配过程中保持标本的完整性;系统必须在长时间内保持稳定，因为许多生物库样本可能会无限期储存;必须使用功能封闭的访问系统，以避免样本取出时的污染。本研究审查了一种新的市售小瓶配置容器的适用性，该容器采用血袋式密封件和穿刺系统，可密封并在冻存和生物库程序中保持稳定。这种基于小瓶的系统允许在样品处理期间满足当前良好制造/组织规范（cGTP）要求，并且可以提供护理者容易递送的益处。在本研究中，对CellSeal®封闭系统冷冻管进行了评价，并与标准螺旋盖小瓶进行了比较。通过运输和维持冻存间充质干细胞模型的功能活力，评价CellSeal系统的耐久性、闭合完整性。这项初步概念验证研究的结果表明，CellSeal小瓶非常适合生物保存和生物库，并为小体积冷冻的临床和商业细胞治疗产品提供了合适的容器系统。
The packaging system chosen for biopreservation is critical for many reasons. An ideal biopreservation container system must provide for closure integrity, sample stability and ready access to the preserved material. This means the system needs to be hermetically sealed to ensure integrity of the specimen is maintained throughout processing, storage and distribution; the system must remain stable over long periods of time as many biobanked samples may be stored indefinitely; and functionally closed access systems must be used to avoid contamination upon sample withdraw. This study reviews the suitability of a new commercially available vial configuration container utilizing blood bag style closure and access systems that can be hermetically sealed and remain stable through cryopreservation and biobanking procedures. This vial based systems allow for current good manufacturing/tissue practice (cGTP) requirements during processing of samples and may provide the benefit of ease of delivery by a care giver. In this study, the CellSeal®closed system cryovial was evaluated and compared to standard screw cap vials. The CellSeal system was evaluated for durability, closure integrity through transportation and maintenance of functional viability of a cryopreserved mesenchymal stem cell model. The results of this initial proof-of-concept study indicated that the CellSeal vials are highly suitable for biopreservation and biobanking, and provide a suitable container system for clinical and commercial cell therapy products frozen in small volumes.