Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.
Concordia University Irvine, 1530 Concordia West, Irvine, CA 92612, United States of America.
Biofabrication. 2024 Jun 3;16(3). doi: 10.1088/1758-5090/ad4de2.
Toward the translation of allogeneic cell therapy products, cell banks are needed not only to manufacture the final human product but also during the preclinical evaluation of an animal-based analogous cellular product (ACP). These cell banks need to be established at both the master cell bank (MCB) level and the working cell bank (WCB) level. Inasmuch as most of the development of cell therapy products is at academic centers, it is imperative that academic researchers understand how to establish MCBs and WCBs within an academic environment. To illustrate this process, using articular cartilage as the model, a cell bank for an ACP was developed (MCBs at passage 2, WCBs at passage 5) to produce self-assembled neocartilage for preclinical evaluation (constructs at passage 7). The cell bank system is estimated to be able to produce between 160 000 and 400 000 constructs for each of the six MCBs. Overall, the ACP cell bank yielded constructs that are analogous to the intended human product, which is critical toward conducting preclinical evaluations of the ACP for inclusion in an Investigational New Drug application to the FDA.
在同种异体细胞治疗产品的翻译中，不仅需要细胞库来制造最终的人类产品，还需要在基于动物的类似细胞产品（ACP）的临床前评估中使用细胞库。这些细胞库需要在主细胞库（MCB）和工作细胞库（WCB）两个层面上建立。由于大多数细胞治疗产品的开发都在学术中心进行，因此学术研究人员必须了解如何在学术环境中建立 MCB 和 WCB。为了说明这一过程，我们以关节软骨作为模型，开发了一种 ACP 的细胞库（MCB 在第 2 代，WCB 在第 5 代），以生产用于临床前评估的自组装新软骨（第 7 代构建体）。据估计，每个 MCB 可以生产 16 万到 40 万个构建体。总的来说，ACP 细胞库产生的构建体与预期的人类产品类似，这对于对 ACP 进行临床前评估并将其纳入向 FDA 提交的新药研究申请至关重要。
