Pharma Services, Thermo Fisher Scientific, San Diego, California, USA; Biomedical Engineering, California Polytechnic State University: San Luis Obispo, San Lius Obispo, California, USA.
Pharma Services, Thermo Fisher Scientific, San Diego, California, USA.
Cytotherapy. 2023 Oct;25(10):1107-1112. doi: 10.1016/j.jcyt.2023.05.005. Epub 2023 Jun 7.
Cell therapies present a promising treatment for a variety of diseases and are a rapidly growing market. This facilitates the need for robust biomanufacturing processes that can be implemented early during process establishment which enables scalable and reproducible manufacturing. Historically, cell therapy has used equipment originally repurposed from biologics, where the supernatant is harvested at the end of production and not the cells. Unlike biologics, cell therapy requires the preservation of cell phenotype and potency, as well as the functional recovery of the cells for the final formulation. These traditional equipment platforms have been widely adopted and, in many cases, successfully. However, given that cell therapy processes are complex, equipment specifically designed for the intended application will add immense value by producing products that are pure, potent and stable. New equipment better suited for cell therapy is being introduced to improve efficiency and product quality compared with current systems, fill key gaps that exist in current workflows or address an emerging need in new paradigms. Integration of these new instruments in laboratories using current Good Manufacturing Practices to produce cell-based drug products and drug substances requires a risk-based approach to evaluate features based on suitability and compliance with regulatory requirements. The speed at which new equipment is evaluated and implemented into new workflows is critical to match the speed of therapeutic product innovations and manufacturing capabilities. Here, we outline a framework to evaluate new equipment and de-risk implementation based on a series of features, namely, hardware, software, consumables, and workflow compatibility for the intended use. A hypothetical evaluation of three cell processing workflows is used as an example to inform equipment deployment for early process establishment and translational use for current Good Manufacturing Practices-destined workflows.
细胞治疗为多种疾病提供了一种有前途的治疗方法，是一个快速增长的市场。这就需要有强大的生物制造工艺，以便在工艺建立的早期实施，从而实现可扩展和可重复的制造。从历史上看，细胞疗法使用的设备最初是从生物制品中重新利用的，生物制品在生产结束时收获的是上清液，而不是细胞。与生物制品不同，细胞疗法需要保持细胞表型和效力，以及细胞的功能恢复，以用于最终制剂。这些传统的设备平台已经被广泛采用，而且在许多情况下都取得了成功。然而，鉴于细胞疗法工艺的复杂性，专门为特定应用设计的设备将通过生产出纯净、有效和稳定的产品，带来巨大的价值。新的设备更适合细胞治疗，与当前系统相比，可提高效率和产品质量，填补当前工作流程中的关键空白，或满足新范例中的新兴需求。为了生产基于细胞的药物产品和药物物质，使用当前良好生产规范将这些新仪器集成到实验室中，需要采用基于风险的方法，根据适用性和对监管要求的合规性来评估特征。评估新设备并将其快速集成到新工作流程中，以匹配治疗产品创新和制造能力的速度至关重要。在这里，我们概述了一个基于一系列特征（即硬件、软件、消耗品和预期用途的工作流程兼容性）评估新设备和降低风险的框架。以三个细胞处理工作流程的假设评估为例，为早期工艺建立和当前良好生产规范预期工作流程的转化用途提供设备部署信息。
