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前途，而且增长迅速。 治疗产品不是药丸--它们是从患者身上获取的活细胞(有时是细胞 银行)，并被运送到一家制药公司，由Modifi提取细胞，然后送回重新- 注射到病人体内。物流在这一过程中扮演着超大的角色，因为样品需要 在整个运输过程中保持超低温。因为这些样品是个性化的 对于特定的患者，它们不能被其他东西取代。如果损坏或切换，结果将是 变得可怕。 当今最先进的装运技术是，液氮温度下的干式托运人 实际连接到干式托运人的温度记录仪-但它们报告托运人的温度， 不是样品，所以如果样品被取出进行检查，这将不会被记录下来。 再生医学疗法要想取得成功，冷冻的端到端过程至关重要， 储存和解冻严格遵守DefiNed协议。瞬变变暖事件 在整个运输和分销过程中，产品温度的变化会对样品产生负面影响 并导致较差的临床结果。因此，有必要验证优化的冷链实践 每个样本单独使用，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种功能性试验产品，该产品将提供现场样品， 发货前、发货期间和发货后的端到端温度记录。软件将比较User-defiNed协议 标准与样品温度记录相一致，并将为样品的使用提供通过/不通过的决定。 该项目的目标是：(A)开发记录温度历史的随样品电子设备(on-fi)。 以及2°C精度的时间戳，(B)开发需要的托运人电子产品 使用电池运行3天，并记录带时间戳的样品温度，并将数据传输回 样品保管人，以及(C)开发一种低温容器，使样品数据采集保持活动状态，同时 样品在实验室中移动，并且finally(D)质量保证站可以通知最终用户 通过对照协议为此设定的标准来检查样本的温度记录，样本是可行的 样本。

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.