End to End, Cold Chain Validation Using Sample Attached History Log

摘要 各种再生医学疗法在规模和类型上都很有希望并迅速发展。 治疗产品不是药丸--它们是从病人身上采集的活细胞（有时是细胞 银行），并运送到一家制药公司，修改细胞，然后将它们送回重新。 注射到病人体内物流在这一过程中发挥了巨大的作用，因为样品需要 在整个运输过程中保持超低温。因为这些样本是个性化的 对于特定的病人来说，它们是不能用其他东西代替的。如果损坏或调换， 可怕。 当今最先进的运输技术是，在液氮温度下的干燥运输箱， 温度记录器，物理连接到干燥装运箱-但它们报告装运箱的温度， 而不是样品，因此如果样品被取出进行检查，则不会记录。 为了使再生医学疗法取得成功，冷冻的端到端过程至关重要， 储存和解冻严格按照精确定义的方案进行。短暂变暖事件 并且在整个运输和分配过程中产品温度的变化会对样品产生负面影响 并导致不良的临床结果。因此，有必要验证优化的冷链实践 为每个样本单独进行，以确保最高质量的治疗结果。 这一快速通道提案的目标是开发一个功能性试验产品， 运输之前、期间和之后的端到端温度日志。软件将比较用户定义的方案 标准与样品温度记录，并将提供一个去/不去决定使用的样品。 该项目的具体目标是：（a）开发记录温度历史的样品电子器件 样品的沿着以及精确度为2 °C的时间戳，（B）开发需要 使用电池运行3天，记录时间戳样本温度，并将数据传输回 样品保管员，以及（c）开发一种低温容器，该低温容器可以保持样品数据采集活动，同时 在实验室中移动的样品，以及最后（d）质量保证站，其可以通知最终用户， 通过对照方案设定的标准检查样品的温度记录， sample.

Abstract Regenerative medicine therapies of various kinds are promising and rapidly growing, both in scale and type. The therapeutic products are not pills–they are living cells that are harvested from a patient (or sometimes a cell bank) and are shipped to a pharmaceutical company that modifies the cells and then sends them back to be re- injected into the patient. Logistics plays an outsize role in this process because the samples need to be maintained at ultra-low temperatures throughout the shipping process. Because these samples are personalized to a particular patient, they are not replaceable with something else. If damaged or switched, the outcome will be dire. The state-of-the-art shipment technology today is, a dry shipper at liquid nitrogen temperature with a temperature logger that is physically attached to the dry shipper–but they report the temperature of the shipper, not the sample so if a sample is removed for inspection, this will not be recorded. For regenerative medicine therapies to be successful, it is essential that the end-to-end processes of freezing, storage, and thawing are carried out in strict adherence to precisely defined protocols. Transient warming events and variability in product temperatures throughout shipping and distribution can negatively affect the samples and contribute to poor clinical outcomes. Therefore, it is necessary to validate optimized cold chain practices individually for each sample, to ensure the highest quality therapeutic outcomes. The goal of this fast-track proposal is to develop a functional pilot product that will provide an on-the-sample, end to end temperature log before, during, and after shipping. Software will compare user-defined protocol criteria with the sample temperature record and will provide a go / no-go decision for use of the sample. The specific aims of the project are: (a) develop the on-sample electronics that records the temperature history of the sample along with timestamps with an accuracy of 2 °C, (b) develop the shipper electronics that needs to operate for 3 days on batteries and record time stamped sample temperatures and transmits that data back to the sample custodian, and (c) develop a cryogenic container that can keep the sample data acquisition active while the samples moving around in the lab, and finally (d) a quality assurance station the can inform the end user if the sample is viable by checking the sample's temperature record against the criteria set by the protocols for that sample.