Navigating the Complexities of CGT Clinical Trial Sample Management
As cell and gene therapies (CGT) advance into the clinical stage, many cold chain complexities arise not only for these novel products but also for the biological samples that must be collected from patients during clinical trials. Managing these sensitive materials—including storage, transportation, and tracking—requires robust and adaptable systems to ensure safety, integrity, and regulatory compliance that are essential for FDA review.
We interviewed Kathi Shea, Senior Director of Repository Innovation at Azenta Life Sciences, to learn how biotech companies can better navigate the clinical phases of CGT development.
临床试验会给CGT开发带来哪些后勤挑战?
临床试验赞助商需要在接受治疗后将研究性药品的递送给临床部位和样本收集。这些过程是交织在一起的,有一个可以支持从第0阶段到第3阶段及以后的活动的合作伙伴是一个优势。118金宝搏app
When storing and handling clinical-phase samples and materials, their fragility cannot be overstated. Retrieving materials manually from a liquid nitrogen freezer can quickly warm the targeted and non-targeted samples in unintended ways. Repeated exposure over time has a compounding effect as well. If I move a box of samples from -180˚C to ambient conditions, I basically have 90 seconds before it starts crossing the glass transition temperature, the point at which degradation occurs. Automated units, on the other hand, can keep biological materials well below that critical temperature throughout the entire retrieval process, significantly lowering the risk of degradation.
您如何保持高级疗法的质量,其中许多保质期和储存要求的要求很短?
您需要一个符合所有监管要求的强大质量管理系统,包括良好的制造实践(GMP)和良好的组织实践(GTP),为那些被认为是血液产品的人。同样,从一开始就一直运输到最终分布至关重要的那一刻起,完全可追溯性至关重要。最后,具有自动化和受过良好训练人员的全球设施网络为CGT公司提供了最快的途径来推进其计划。
存储和管理CGT材料和临床样品需要哪些保障措施?
库存管理系统应具有各种保障措施和风险缓解协议。如果您定义了一个项目应在一定温度下具有一组材料,则该系统不应允许您将其存储在不同的温度下。
从基础架构的角度来看,您需要完成所有增加存储单元内温度安全性和稳定性的所有操作。例如,应通过真空隔离管道喂食液氮冰柜,无论是自动化的还是手动的,可确保根据需求立即递送LN2。所有线路都应始终保持底漆,以使冷LN2始终到达冰柜。在液氮输送的任何中断时,具有大型LN2储罐来采购单元,这增加了另一层保护。
What about regulatory compliance for advanced therapies?
Cell and gene therapies are viewed as innovative therapies by the FDA. For regulatory purposes, they may be treated more like a pharmaceutical or more like a blood product. A quality system that is set up to handle both is required. There is also a strong need to obtain state licensure to support distribution globally for both types of products. Customers also benefit from additional accreditation and certifications like ISO, CAP, EMA, and PMDA.
Azenta Life Sciences在CGT开发的各个阶段提供了全面的解决方案。了解我们如何从目标发现到扩展。118金宝搏app
About Kathi Shea
Kathi Shea是Azenta Life Sciences存储库创新的高级总监。她曾在伊斯伯董事会任职8年,包括董事,秘书司库和总裁。她拥有30年的领先生物措施计划的经验,并就生物座席设计和质量系统的设计以及最佳的收集,保存和注释生物传感收集的方法提供建议。